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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05811364
Registration number
NCT05811364
Ethics application status
Date submitted
14/03/2023
Date registered
13/04/2023
Date last updated
9/11/2023
Titles & IDs
Public title
The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease
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Scientific title
The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease
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Secondary ID [1]
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VBX 22-06
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aortoiliac Occlusive Disease
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Peripheral Arterial Disease
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Condition category
Condition code
Cardiovascular
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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 - Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Treatment: Devices - Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent
Active comparator: VBX Device Group - Subject in this group will receive treatment with the GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
Active comparator: BMS Control Group - Subjects in this group will receive treatment with a commercially available bare metal stent (BMS) that is approved for treatment of the disease
Treatment: Devices: Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.
Treatment: Devices: Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent
Treatment of target lesions in the common and/or external iliac arteries by stenting with a commercially available bare metal stent that is approved for treatment of the disease.
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Intervention code [1]
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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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Primary Patency
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Assessment method [1]
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Blood flow through the target lesion (no evidence of binary restenosis \>50% or occlusion) without a Target Lesion Revascularization (TLR).
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Timepoint [1]
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1 year
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Secondary outcome [1]
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Technical success
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Assessment method [1]
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Deployment of device with \< 30% residual stenosis on final angiography.
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Timepoint [1]
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at the procedure
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Secondary outcome [2]
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Acute procedural success
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Assessment method [2]
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Binary assessment based on technical success and freedom from device or procedure-related serious adverse events (SAE) requiring intervention.
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Timepoint [2]
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at the procedure
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Secondary outcome [3]
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Clinical success
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Assessment method [3]
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Improvement from baseline of at least 1 Rutherford Category and freedom from device or procedure-related SAE requiring intervention.
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Timepoint [3]
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Through 1 month
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Secondary outcome [4]
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Hemodynamic Status
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Assessment method [4]
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Change in Ankle-brachial index (ABI)/toe-brachial index (TBI) as compared to baseline
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Timepoint [4]
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Through 5 years
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Secondary outcome [5]
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Change in EQ-5D-5L
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Assessment method [5]
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Change in EQ-5D-5L responses as compared to baseline. The EQ-5D-5L Questionnaire measures quality of life (QoL) over 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is measured over five levels from no problems to extreme problems. Scored on a 0 to 100 scale with 0 as the worst possible health and 100 is the best possible health.
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Timepoint [5]
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Through 5 years
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Secondary outcome [6]
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Change in WIQ
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Assessment method [6]
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Change in Walking Impairment Questionnaire (WIQ) responses as compared to baseline. The WIQ is a validated QoL measurement of walking abilities over 3 dimensions: distance, speed, and stair-climbing. Scored on a 0 to 100 scale with 0 as no degree of difficulty and 100 is the highest degree of difficulty.
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Timepoint [6]
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Through 5 years
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Secondary outcome [7]
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Primary patency
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Assessment method [7]
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Blood flow through the target lesion (no evidence of binary restenosis \>50% or occlusion) without a Target Lesion Revascularization (TLR).
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Timepoint [7]
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Through 5 years
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Secondary outcome [8]
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Freedom from binary restenosis
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Assessment method [8]
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Freedom from binary restenosis. binary restenosis defined as evidence of \>50% restenosis or occlusion of the target lesion(s) based on core lab adjudicated duplex ultrasound or angiography
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Timepoint [8]
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Through 5 years
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Secondary outcome [9]
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Primary assisted patency
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Assessment method [9]
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Blood flow maintained (no evidence of occlusion) through the target lesion with or without a Target Lesion Revascularization (TLR).
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Timepoint [9]
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Through 5 years
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Secondary outcome [10]
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Secondary patency
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Assessment method [10]
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Blood flow through the target lesion with or without a Target Lesion Revascularization (TLR).
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Timepoint [10]
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Through 5 years
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Secondary outcome [11]
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Freedom from target lesion revascularization
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Assessment method [11]
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Freedom from target lesion revascularization (TLR). TLR defined as endovascular or surgical intervention performed on the target lesion(s).
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Timepoint [11]
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Through 5 years
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Secondary outcome [12]
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Cumulative reintervention rate
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Assessment method [12]
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Rate of first and recurrent Target Lesion Revascularization (TLR).
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Timepoint [12]
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Through 5 years
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Secondary outcome [13]
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Freedom from clinically driven target lesion revascularization
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Assessment method [13]
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Freedom from clinically driven target lesion revascularization. Endovascular or surgical intervention performed on the target lesion(s) in response to recurrent symptoms (increase = 1 Rutherford Category).
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Timepoint [13]
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Through 5 years
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Secondary outcome [14]
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Amputation-free survival
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Assessment method [14]
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Binary assessment based on freedom from major amputation (target limb, amputation above the metatarsals) and all-cause mortality
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Timepoint [14]
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Through 5 years
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Secondary outcome [15]
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Survival
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Assessment method [15]
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Freedom from all-cause mortality
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Timepoint [15]
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Through 5 years
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Secondary outcome [16]
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Change in Rutherford Category
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Assessment method [16]
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Change in Rutherford Category as compared to baseline. Scaled from 0 to 6, with 0 as asymptotic and 6 as major tissue loss, extending above the transmetatarsal (TM) level, functional foot no longer salvageable.
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Timepoint [16]
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Through 5 years
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Eligibility
Key inclusion criteria
* Age = 18 years at time of informed consent signature
* Informed Consent Form (ICF) is signed by the subject
* Subject can comply with protocol requirements, including follow-up
* Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford Category 2-5)
* Patient has de novo or restenotic lesion(s) found in the common and/or external iliac artery(ies)
* Patient has: Unilateral or bilateral single or multiple lesions (>50% stenosis or chronic total occlusion) each between 4 and 11 cm in length
* Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm
* Patient has a sufficient (<50% stenotic) common femoral artery and at least one sufficient (<50% stenotic) femoral artery (deep or superficial).
* Patient has at least one sufficient (<50% stenotic) infrapopliteal run-off vessel.
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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
* Life expectancy <1 year
* Patient is pregnant at time of informed consent.
* Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin).
* Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and not undergoing hemodialysis.
* Patient has evidence of a systemic infection.
* Patient has a known intolerance to antithrombotic medications that prevent compliance with study or control device Instructions for Use.
* Patient has had vascular catheterization of the lower extremities within 30 days of randomization (excluding diagnostic angiograms for the study procedure).
* Patient has previous stenting in the iliac arteries.
* Patient has previous surgical bypass in the target limb.
* Patient is currently participating in another investigative clinical study unless received written approval by the sponsor.
* Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy, lithotripsy, or any ablative device to facilitate stent delivery.
* Patient has an abdominal aortic artery lesion or aneurysm.
* Patient has a lesion that requires stent placement within 2 cm of the inguinal ligament.
* Patient has isolated common iliac artery stenosis that can be treated with a single device (i.e., common iliac artery stenosis that does not require kissing stents or extend into the external iliac artery).
* Patient has outflow disease that requires concomitant interventions (i.e. common femoral endarterectomy or femoral / tibial revascularization).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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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
Recruiting
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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
17/10/2023
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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
30/04/2031
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Actual
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Sample size
Target
244
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Pennsylvania
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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Germany
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State/province [5]
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Regensburg
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Country [6]
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Netherlands
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State/province [6]
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Arnhem
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Country [7]
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New Zealand
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State/province [7]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
W.L.Gore & Associates
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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 objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.
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Trial website
https://clinicaltrials.gov/study/NCT05811364
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Makensley Lordeus
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Address
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Country
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Phone
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623-234-5989
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Fax
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Email
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[email protected]
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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 not provided in
https://clinicaltrials.gov/study/NCT05811364
Download to PDF