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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01023789
Registration number
NCT01023789
Ethics application status
Date submitted
30/11/2009
Date registered
2/12/2009
Date last updated
14/02/2018
Titles & IDs
Public title
ABSORB EXTEND Clinical Investigation
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Scientific title
ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold (BVS) System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
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Secondary ID [1]
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0
ACTRN12610000131055
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Secondary ID [2]
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0
09-386
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Universal Trial Number (UTN)
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Trial acronym
ABSORB EXTEND
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Myocardial Ischemia
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0
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Coronary Artery Stenosis
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0
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Coronary Disease
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0
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Coronary Artery Disease
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0
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Coronary Restenosis
0
0
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Cardiovascular Disease
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0
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Condition category
Condition code
Cardiovascular
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0
0
0
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Coronary heart disease
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Cardiovascular
0
0
0
0
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Other cardiovascular diseases
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Cardiovascular
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0
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - ABSORB BVS
Experimental: ABSORB BVS - Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease
Treatment: Devices: ABSORB BVS
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation
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Intervention code [1]
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0
Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
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Assessment method [1]
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0
The composite endpoint composed of
* Cardiac death,
* Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),
* Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI).
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Timepoint [1]
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0
= 7 days post index procedure (In hospital)
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Primary outcome [2]
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0
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
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Assessment method [2]
0
0
The composite endpoint composed of
* Cardiac death,
* Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),
* Ischemia-driven target lesion revascularization (TLR) by CABG or PCI.
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Timepoint [2]
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0
0 to 30 days
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Primary outcome [3]
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0
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
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Assessment method [3]
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0
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
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Timepoint [3]
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0
0 to 180 days
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Primary outcome [4]
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0
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
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Assessment method [4]
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0
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
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Timepoint [4]
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0
0 to 1 year
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Secondary outcome [1]
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0
Clinical Device Success
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Assessment method [1]
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Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis \< 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met.
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Timepoint [1]
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On day 0 (immediate post-index procedure)
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Secondary outcome [2]
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0
Clinical Procedure Success
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Assessment method [2]
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Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of \< 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In a dual lesion setting both lesions must meet clinical procedure success.
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Timepoint [2]
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0
On day 0 (immediate post-index procedure)
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Secondary outcome [3]
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0
Number of Participants With Cardiac Death
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Assessment method [3]
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0
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
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Timepoint [3]
0
0
= 7 days post index procedure (In-hospital )
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Secondary outcome [4]
0
0
Number of Participants With Myocardial Infarction (MI) - Per Protocol
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Assessment method [4]
0
0
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of creatine kinase (CK) levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
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Timepoint [4]
0
0
= 7 days post index procedure (In-hospital )
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Secondary outcome [5]
0
0
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
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Assessment method [5]
0
0
Revascularization at the target lesion associated with any of the following:
* Positive functional ischemia study.
* Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).
* Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
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Timepoint [5]
0
0
= 7 days post index procedure (In-hospital )
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Secondary outcome [6]
0
0
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
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Assessment method [6]
0
0
Revascularization in the target vessel associated with any of the following:
* Positive functional ischemia study.
* Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).
* Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
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Timepoint [6]
0
0
= 7 days post index procedure (In-hospital )
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Secondary outcome [7]
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0
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
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Assessment method [7]
0
0
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Timepoint [7]
0
0
= 7 days post index procedure (In-hospital )
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Secondary outcome [8]
0
0
Number of Participants With Cardiac Death
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Assessment method [8]
0
0
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
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Timepoint [8]
0
0
0 to 30 days
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Secondary outcome [9]
0
0
Number of Participants With Myocardial Infarction (MI) - Per Protocol
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Assessment method [9]
0
0
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
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Timepoint [9]
0
0
0 to 30 days
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Secondary outcome [10]
0
0
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
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Assessment method [10]
0
0
Revascularization at the target lesion associated with any of the following:
* Positive functional ischemia study.
* Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).
* Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
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Timepoint [10]
0
0
0 to 30 days
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Secondary outcome [11]
0
0
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
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Assessment method [11]
0
0
Revascularization in the target vessel associated with any of the following:
* Positive functional ischemia study.
* Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).
* Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
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Timepoint [11]
0
0
0 to 30 days
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Secondary outcome [12]
0
0
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
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Assessment method [12]
0
0
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Timepoint [12]
0
0
0 to 30 days
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Secondary outcome [13]
0
0
Number of Participants With Cardiac Death
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Assessment method [13]
0
0
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
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Timepoint [13]
0
0
0 to 180 days
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Secondary outcome [14]
0
0
Number of Participants With Myocardial Infarction (MI) - Per Protocol
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Assessment method [14]
0
0
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
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Timepoint [14]
0
0
0 to 180 days
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Secondary outcome [15]
0
0
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
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Assessment method [15]
0
0
Revascularization at the target lesion associated with any of the following:
* Positive functional ischemia study.
* Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).
* Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Query!
Timepoint [15]
0
0
0 to 180 days
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Secondary outcome [16]
0
0
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
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Assessment method [16]
0
0
Revascularization in the target vessel associated with any of the following:
* Positive functional ischemia study.
* Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).
* Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Query!
Timepoint [16]
0
0
0 to 180 days
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Secondary outcome [17]
0
0
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
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Assessment method [17]
0
0
Query!
Timepoint [17]
0
0
0 to 180 days
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Secondary outcome [18]
0
0
Number of Participants With Cardiac Death
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Assessment method [18]
0
0
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
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Timepoint [18]
0
0
0 to 1 year
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Secondary outcome [19]
0
0
Number of Participants With Myocardial Infarction (MI) - Per Protocol
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Assessment method [19]
0
0
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
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Timepoint [19]
0
0
0 to 1 year
Query!
Secondary outcome [20]
0
0
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
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Assessment method [20]
0
0
Revascularization at the target lesion associated with any of the following:
* Positive functional ischemia study.
* Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).
* Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Query!
Timepoint [20]
0
0
0 to 1 year
Query!
Secondary outcome [21]
0
0
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
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Assessment method [21]
0
0
Revascularization in the target vessel associated with any of the following:
* Positive functional ischemia study.
* Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).
* Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Query!
Timepoint [21]
0
0
0 to 1 year
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Secondary outcome [22]
0
0
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
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Assessment method [22]
0
0
Query!
Timepoint [22]
0
0
0 to 1 year
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Secondary outcome [23]
0
0
Number of Participants With Cardiac Death
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Assessment method [23]
0
0
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Query!
Timepoint [23]
0
0
0 to 2 year
Query!
Secondary outcome [24]
0
0
Number of Participants With Myocardial Infarction (MI) - Per Protocol
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Assessment method [24]
0
0
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
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Timepoint [24]
0
0
0 to 2 year
Query!
Secondary outcome [25]
0
0
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
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Assessment method [25]
0
0
Revascularization at the target lesion associated with any of the following:
* Positive functional ischemia study.
* Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).
* Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Query!
Timepoint [25]
0
0
0 to 2 year
Query!
Secondary outcome [26]
0
0
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
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Assessment method [26]
0
0
Revascularization in the target vessel associated with any of the following:
* Positive functional ischemia study.
* Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).
* Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Query!
Timepoint [26]
0
0
0 to 2 year
Query!
Secondary outcome [27]
0
0
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Query!
Assessment method [27]
0
0
Query!
Timepoint [27]
0
0
0 to 2 year
Query!
Secondary outcome [28]
0
0
Number of Participants With Cardiac Death
Query!
Assessment method [28]
0
0
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Query!
Timepoint [28]
0
0
0 to 3 years
Query!
Secondary outcome [29]
0
0
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Query!
Assessment method [29]
0
0
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of CK levels to = two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Query!
Timepoint [29]
0
0
0 to 3 years
Query!
Secondary outcome [30]
0
0
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Query!
Assessment method [30]
0
0
Revascularization at the target lesion associated with any of the following:
* Positive functional ischemia study.
* Ischemic symptoms and angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).
* Revascularization of a target lesion with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Query!
Timepoint [30]
0
0
0 to 3 years
Query!
Secondary outcome [31]
0
0
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Query!
Assessment method [31]
0
0
Revascularization in the target vessel associated with any of the following:
* Positive functional ischemia study.
* Ischemic symptoms and an angiographic minimal lumen diameter stenosis = 50% by core laboratory quantitative coronary angiography (QCA).
* Revascularization of a target vessel with diameter stenosis = 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Query!
Timepoint [31]
0
0
0 to 3 years
Query!
Secondary outcome [32]
0
0
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Query!
Assessment method [32]
0
0
Query!
Timepoint [32]
0
0
0 to 3 years
Query!
Secondary outcome [33]
0
0
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Query!
Assessment method [33]
0
0
The composite endpoint composed of
* Cardiac death,
* Myocardial infarction (Q wave and Non-Q wave),
* Ischemia-driven target vessel revascularization by CABG or PCI.
Query!
Timepoint [33]
0
0
= 7 days post index procedure (In hospital)
Query!
Secondary outcome [34]
0
0
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Query!
Assessment method [34]
0
0
The composite endpoint composed of
* Cardiac death,
* Myocardial infarction (Q wave and Non-Q wave),
* Ischemia-driven target vessel revascularization by CABG or PCI.
Query!
Timepoint [34]
0
0
0 to 30 days
Query!
Secondary outcome [35]
0
0
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Query!
Assessment method [35]
0
0
The composite endpoint composed of
* Cardiac death,
* Myocardial infarction (Q wave and Non-Q wave),
* Ischemia-driven target vessel revascularization by CABG or PCI.
Query!
Timepoint [35]
0
0
0 to 180 days
Query!
Secondary outcome [36]
0
0
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Query!
Assessment method [36]
0
0
The composite endpoint composed of
* Cardiac death,
* Myocardial infarction (Q wave and Non-Q wave),
* Ischemia-driven target vessel revascularization by CABG or PCI.
Query!
Timepoint [36]
0
0
0 to 1 year
Query!
Secondary outcome [37]
0
0
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Query!
Assessment method [37]
0
0
The composite endpoint composed of
* Cardiac death,
* Myocardial infarction (Q wave and Non-Q wave),
* Ischemia-driven target vessel revascularization by CABG or PCI.
Query!
Timepoint [37]
0
0
0 to 2 years
Query!
Secondary outcome [38]
0
0
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Query!
Assessment method [38]
0
0
The composite endpoint composed of
* Cardiac death,
* Myocardial infarction (Q wave and Non-Q wave),
* Ischemia-driven target vessel revascularization by CABG or PCI.
Query!
Timepoint [38]
0
0
0 to 3 years
Query!
Secondary outcome [39]
0
0
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Query!
Assessment method [39]
0
0
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Query!
Timepoint [39]
0
0
0 to 2 years
Query!
Secondary outcome [40]
0
0
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Query!
Assessment method [40]
0
0
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Query!
Timepoint [40]
0
0
0 to 3 years
Query!
Secondary outcome [41]
0
0
Number of Participants With Scaffold Thrombosis (Early)
Query!
Assessment method [41]
0
0
According to the Academic Research Consortium (ARC) Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation
\*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Query!
Timepoint [41]
0
0
0 to 30 days
Query!
Secondary outcome [42]
0
0
Number of Participants With Scaffold Thrombosis
Query!
Assessment method [42]
0
0
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation
\*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Query!
Timepoint [42]
0
0
0 to 180 days
Query!
Secondary outcome [43]
0
0
Number of Participants With Scaffold Thrombosis (Late)
Query!
Assessment method [43]
0
0
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation
\*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Query!
Timepoint [43]
0
0
31 - 365 days
Query!
Secondary outcome [44]
0
0
Number of Participants With Scaffold Thrombosis
Query!
Assessment method [44]
0
0
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation
\*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Query!
Timepoint [44]
0
0
0 to 1 year
Query!
Secondary outcome [45]
0
0
Number of Participants With Scaffold Thrombosis (Very Late)
Query!
Assessment method [45]
0
0
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation
\*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Query!
Timepoint [45]
0
0
366 days to 2 years
Query!
Secondary outcome [46]
0
0
Number of Participants With Scaffold Thrombosis
Query!
Assessment method [46]
0
0
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation
\*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
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Timepoint [46]
0
0
0 to 2 years
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Secondary outcome [47]
0
0
Number of Participants With Scaffold Thrombosis
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Assessment method [47]
0
0
According to the ARC Definition, Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.
Timing:
Acute stent thrombosis\*: 0 - 24 hours post stent implantation Subacute stent thrombosis\*: \>24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: \>1 year post stent implantation
\*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
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Timepoint [47]
0
0
0 to 3 years
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Secondary outcome [48]
0
0
Area Stenosis (%)
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Assessment method [48]
0
0
Query!
Timepoint [48]
0
0
18 months
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Secondary outcome [49]
0
0
Minimum Lumen Area
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Assessment method [49]
0
0
Query!
Timepoint [49]
0
0
18 months
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Secondary outcome [50]
0
0
Mean Vessel Area
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Assessment method [50]
0
0
Query!
Timepoint [50]
0
0
18 months
Query!
Secondary outcome [51]
0
0
Minimum Vessel Area
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Assessment method [51]
0
0
Query!
Timepoint [51]
0
0
18 months
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Secondary outcome [52]
0
0
Maximum Vessel Area
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Assessment method [52]
0
0
Query!
Timepoint [52]
0
0
18 months
Query!
Secondary outcome [53]
0
0
Mean Lumen Area
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Assessment method [53]
0
0
Query!
Timepoint [53]
0
0
18 months
Query!
Secondary outcome [54]
0
0
Maximum Lumen Area
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Assessment method [54]
0
0
Query!
Timepoint [54]
0
0
18 months
Query!
Secondary outcome [55]
0
0
Mean Plaque Area
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Assessment method [55]
0
0
Query!
Timepoint [55]
0
0
18 months
Query!
Secondary outcome [56]
0
0
Minimum Plaque Area
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Assessment method [56]
0
0
Query!
Timepoint [56]
0
0
18 months
Query!
Secondary outcome [57]
0
0
Maximum Plaque Area
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Assessment method [57]
0
0
Query!
Timepoint [57]
0
0
18 months
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Secondary outcome [58]
0
0
Mean Reference Area
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Assessment method [58]
0
0
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Timepoint [58]
0
0
18 months
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Secondary outcome [59]
0
0
Calculated Minimum Lumen Diameter
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Assessment method [59]
0
0
The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - treated lesion, treated site or treated segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.
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Timepoint [59]
0
0
18 months
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Secondary outcome [60]
0
0
Calculated Diameter Stenosis
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Assessment method [60]
0
0
The value calculated as 100 \* (1 - Minimum Lumen Diameter (MLD) / reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
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Timepoint [60]
0
0
18 months
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Eligibility
Key inclusion criteria
* Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.
* Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is = 2.0 mm and = 3.3 mm and target lesion length is = 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA).
* Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of = 50% and < 100% with a TIMI flow of = 1.
* If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (LAD with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches).
* Percutaneous interventions for lesions in a non-target vessel are allowed if done = 30 days prior to or if planned to be done 6 months after the index procedure.
* Percutaneous intervention for lesions in the target vessel are allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
* Lesion(s) involving a bifurcation with side branch vessel = 2 mm in diameter and/or ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation.
* Total occlusion (TIMI flow 0), prior to wire passing.
* Target vessel(s) contains visible thrombus.
* Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).
* Subject has received brachytherapy in any epicardial vessel (including side branches).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2016
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Sample size
Target
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Accrual to date
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Final
812
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
0
0
Eastern Heart Clinic, The Prince of Wales Hospital - Randwick
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Recruitment hospital [2]
0
0
Wesley Hospital - Auchenflower
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Recruitment hospital [3]
0
0
St. Vincent's Hospital - Melbourne
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Recruitment hospital [4]
0
0
Monash Medical Center - Melbourne
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Recruitment postcode(s) [1]
0
0
2031 - Randwick
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Recruitment postcode(s) [2]
0
0
- Auchenflower
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Recruitment postcode(s) [3]
0
0
3065 - Melbourne
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Recruitment postcode(s) [4]
0
0
3168 - Melbourne
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Recruitment outside Australia
Country [1]
0
0
Argentina
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State/province [1]
0
0
Buenos Aires
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Country [2]
0
0
Austria
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State/province [2]
0
0
Linz
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Country [3]
0
0
Belgium
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State/province [3]
0
0
Aalst
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Country [4]
0
0
Brazil
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State/province [4]
0
0
Sao Paulo
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Country [5]
0
0
Brazil
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State/province [5]
0
0
Uberlandia
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Country [6]
0
0
Canada
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State/province [6]
0
0
Montreal
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Country [7]
0
0
Canada
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State/province [7]
0
0
Ottawa
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Country [8]
0
0
Canada
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State/province [8]
0
0
Quebec
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Country [9]
0
0
Canada
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State/province [9]
0
0
Toronto
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Country [10]
0
0
China
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State/province [10]
0
0
Hong Kong
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Country [11]
0
0
Denmark
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State/province [11]
0
0
Århus N
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Country [12]
0
0
France
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State/province [12]
0
0
Massy
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Country [13]
0
0
France
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State/province [13]
0
0
Toulouse
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Country [14]
0
0
Germany
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State/province [14]
0
0
Berlin
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Country [15]
0
0
Germany
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State/province [15]
0
0
Heidelberg
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Country [16]
0
0
India
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State/province [16]
0
0
Andhar Pradesh
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Country [17]
0
0
India
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State/province [17]
0
0
Andhra Pradesh
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Country [18]
0
0
India
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State/province [18]
0
0
Ahmedabad
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Country [19]
0
0
India
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State/province [19]
0
0
Chennai
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Country [20]
0
0
India
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State/province [20]
0
0
Gurgaon
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Country [21]
0
0
India
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State/province [21]
0
0
Lucknow
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Country [22]
0
0
India
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State/province [22]
0
0
New Delhi
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Country [23]
0
0
Israel
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State/province [23]
0
0
Petah Tikva
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Country [24]
0
0
Italy
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State/province [24]
0
0
Catanzaro
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Country [25]
0
0
Italy
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State/province [25]
0
0
Milano
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Country [26]
0
0
Japan
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State/province [26]
0
0
Itabashi
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Country [27]
0
0
Japan
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State/province [27]
0
0
Kanagawa
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Country [28]
0
0
Japan
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State/province [28]
0
0
Kansai
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Country [29]
0
0
Japan
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State/province [29]
0
0
Chiyoda-ku
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Country [30]
0
0
Malaysia
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State/province [30]
0
0
Kuala Lumpur
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Country [31]
0
0
Netherlands
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State/province [31]
0
0
Eindhoven
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Country [32]
0
0
Netherlands
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State/province [32]
0
0
Rotterdam
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Country [33]
0
0
New Zealand
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State/province [33]
0
0
Auckland
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Country [34]
0
0
New Zealand
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State/province [34]
0
0
Christchurch
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Country [35]
0
0
Poland
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State/province [35]
0
0
Krakow
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Country [36]
0
0
Singapore
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State/province [36]
0
0
Singapore
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Country [37]
0
0
South Africa
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State/province [37]
0
0
Johannesburg
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Country [38]
0
0
Spain
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State/province [38]
0
0
Madrid
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Country [39]
0
0
Spain
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State/province [39]
0
0
Pontevedra
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Country [40]
0
0
Sweden
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State/province [40]
0
0
Lund
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Country [41]
0
0
Switzerland
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State/province [41]
0
0
Bern
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Country [42]
0
0
Taiwan
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State/province [42]
0
0
Kaohsiung
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Country [43]
0
0
Taiwan
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State/province [43]
0
0
Taipei
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Country [44]
0
0
United Kingdom
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State/province [44]
0
0
Leicester
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Country [45]
0
0
United Kingdom
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State/province [45]
0
0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Abbott Medical Devices
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular.
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Trial website
https://clinicaltrials.gov/study/NCT01023789
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Trial related presentations / publications
Costa JR Jr, Abizaid A, Whitbourn R, Serruys PW, Jepson N, Steinwender C, Stuteville M, Ediebah D, Sudhir K, Bartorelli AL; ABSORB EXTEND investigators. Three-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Final results of the ABSORB EXTEND trial. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):E1-E7. doi: 10.1002/ccd.27715. Epub 2018 Oct 4. Moriyama N, Shishido K, Tanaka Y, Yokota S, Hayashi T, Miyashita H, Koike T, Yokoyama H, Takada T, Nishimoto T, Ochiai T, Tobita K, Yamanaka F, Mizuno S, Murakami M, Takahashi S, Saito S. Neoatherosclerosis 5 Years After Bioresorbable Vascular Scaffold Implantation. J Am Coll Cardiol. 2018 May 1;71(17):1882-1893. doi: 10.1016/j.jacc.2018.02.051. Ishibashi Y, Nakatani S, Sotomi Y, Suwannasom P, Grundeken MJ, Garcia-Garcia HM, Bartorelli AL, Whitbourn R, Chevalier B, Abizaid A, Ormiston JA, Rapoza RJ, Veldhof S, Onuma Y, Serruys PW. Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II). JACC Cardiovasc Interv. 2015 Nov;8(13):1715-26. doi: 10.1016/j.jcin.2015.07.026. Abizaid A, Ribamar Costa J Jr, Bartorelli AL, Whitbourn R, van Geuns RJ, Chevalier B, Patel T, Seth A, Stuteville M, Dorange C, Cheong WF, Sudhir K, Serruys PW; ABSORB EXTEND investigators. The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled. EuroIntervention. 2015 Apr;10(12):1396-401. doi: 10.4244/EIJV10I12A243. Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16. Gogas BD, King SB 3rd, Timmins LH, Passerini T, Piccinelli M, Veneziani A, Kim S, Molony DS, Giddens DP, Serruys PW, Samady H. Biomechanical assessment of fully bioresorbable devices. JACC Cardiovasc Interv. 2013 Jul;6(7):760-1. doi: 10.1016/j.jcin.2013.04.008. No abstract available. Muramatsu T, Onuma Y, Garcia-Garcia HM, Farooq V, Bourantas CV, Morel MA, Li X, Veldhof S, Bartorelli A, Whitbourn R, Abizaid A, Serruys PW; ABSORB-EXTEND Investigators. Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold: an interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials. JACC Cardiovasc Interv. 2013 Mar;6(3):247-57. doi: 10.1016/j.jcin.2012.10.013.
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Public notes
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Contacts
Principal investigator
Name
0
0
Alexandre Abizaid, MD
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Address
0
0
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01023789
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