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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02869087




Registration number
NCT02869087
Ethics application status
Date submitted
31/05/2016
Date registered
16/08/2016

Titles & IDs
Public title
The DESappear Study: Drug Eluting Scaffold
Scientific title
DESappear Study: Drug Eluting Scaffold With an Absorbable Platform for Primary Lower Extremity Arterial Revascularization
Secondary ID [1] 0 0
ELX CL 1501
Universal Trial Number (UTN)
Trial acronym
DESappear
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Vascular Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Akesys Prava Scaffold

Experimental: Single Group - Single Arm study, study subjects are assigned to treatment with the Akesys Prava Scaffold


Treatment: Devices: Akesys Prava Scaffold
Implantation of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral Scaffold System
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Freedom from composite of perioperative death < 30 days and freedom from major adverse limb events (MALE) defined as the occurrence of major amputation, thrombectomy, thrombolysis or major open surgical revascularization
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Primary Patency defined as the freedom from restenosis (>50% diameter reduction defined by Duplex Ultrasound) or clinically driven target lesion revascularization through 6 months
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
Freedom from composite of perioperative death within 30 days and freedom from major adverse limb events (MALE) defined as the occurrence of major amputation, thrombectomy, thrombolysis or major open surgical revascularization.
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Freedom from the composite of target lesion (TL) occlusion, reintervention or restenosis defined as a >50% diameter reduction in the target lesion, as confirmed by Duplex Ultrasound or angiography
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
All cause mortality
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Technical Success defined as the successful delivery and deployment of the device assessed by angiography at the conclusion of the procedure
Timepoint [4] 0 0
Post Procedure- Procedure may take up to 2 hours
Secondary outcome [5] 0 0
Technical Success defined as no implantation of metallic stent assessed by angiography at the conclusion of the procedure
Timepoint [5] 0 0
Post Procedure, procedure may take up to 2 hours
Secondary outcome [6] 0 0
Technical Success defined as < 30%residual stenosis after successful implantation of the scaffold assessed by angiography at the conclusion of the procedure
Timepoint [6] 0 0
Post Procedure, procedure may take up to 2 hours
Secondary outcome [7] 0 0
Major target extremity amputation
Timepoint [7] 0 0
1 month,6 months,12 months, 24 months, 36 months
Secondary outcome [8] 0 0
Minor target extremity amputation
Timepoint [8] 0 0
1 month,6 months,12 months, 24 months, 36 months
Secondary outcome [9] 0 0
Scaffold Thrombosis
Timepoint [9] 0 0
1 month,6 months,12 months, 24 months, 36 months
Secondary outcome [10] 0 0
Target Lesion binary restenosis by duplex ultrasound Peak Systolic Velocity ratio (PSVR>2.4)
Timepoint [10] 0 0
1 month, 6 months,12 months, 24 months, 36 months
Secondary outcome [11] 0 0
Clinically driven target lesion restenosis defined as any intervention due to worsening symptoms, a fall in ABI or TL restenosis as determined by duplex ultrasound
Timepoint [11] 0 0
1 month,6 months,12 months, 24 months, 36 months
Secondary outcome [12] 0 0
Target extremity revascularisation
Timepoint [12] 0 0
1 month,6 months,12 months, 24 months, 36 months
Secondary outcome [13] 0 0
Primary patency of the target lesion
Timepoint [13] 0 0
1 month,6 months,12 months, 24 months, 36 months
Secondary outcome [14] 0 0
Primary assisted patency of the target lesion
Timepoint [14] 0 0
1 month,6 months,12 months, 24 months, 36 months
Secondary outcome [15] 0 0
Secondary patency of the target lesion
Timepoint [15] 0 0
1 month,6 months,12 months, 24 months, 36 months
Secondary outcome [16] 0 0
Rutherford Becker clinical category
Timepoint [16] 0 0
1 month,6 months,12 months, 24 months, 36 months
Secondary outcome [17] 0 0
Ankle Brachial Index in the target extremity
Timepoint [17] 0 0
1 month,6 months,12 months, 24 months, 36 months
Secondary outcome [18] 0 0
Walking Capacity as demonstrated by the Walking Impairment Questionnaire
Timepoint [18] 0 0
1 month,6 months,12 months, 24 months, 36 months
Secondary outcome [19] 0 0
Quality of Life measures using VASCUQoL- disease specific
Timepoint [19] 0 0
1 month,6 months,12 months, 24 months, 36 months
Secondary outcome [20] 0 0
Duplex ultrasound derived Peak Velocity (PSV) at the target lesion
Timepoint [20] 0 0
1 month,6 months,12 months, 24 months, 36 months

Eligibility
Key inclusion criteria
Clinical inclusion criteria:

1. Subject is =18 years of age.
2. Subject has been informed of the nature of the study, agrees to its provisions, is able to provide informed consent, and agrees to undergo all protocol-required follow up examinations and requirements.
3. Subject's life expectancy is at least 1 year.
4. Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 2-4).
5. For females of childbearing potential, a negative pregnancy test within 14 days before index procedure is required
6. Subject is able to take a P2Y12 receptor antagonist (e.g. clopidogrel, ticagrelor, prasugrel or ticagrelor) and acetylsalicylic acid (aspirin).

Angiographic inclusion criteria:

1. A single, de novo native disease segment of the SFA
2. Proximal margin of target lesion is =1 cm distal to the common femoral artery bifurcation; distal margin of target lesion is within the SFA.
3. Vessel diameter from =5.0 mm to =6.0 mm evaluated by on-line quantitative vascular angiography (QVA) after pre-dilatation per core laboratory guidelines.
4. Target lesion diameter reduction =50%
5. Target lesion length =53 mm
6. Patent inflow artery free from significant lesion (=50% diameter reduction;
7. Patent distal popliteal artery free from significant lesion (=50%) with angiographic demonstration of at least one fully patent distal outflow artery (anterior tibial, posterior tibial, or peroneal) to its terminus.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinical exclusion criteria:

1. Previous bypass surgery or stenting at the TL;
2. Percutaneous or open surgical revascularization of the contralateral iliac or infrainguinal arteries =30 days prior to the planned index procedure. Iliac artery lesions may be treated during the index procedure if necessary for approach to the TL;
3. Failure to successfully cross the target lesion with a guide wire;
4. Subject has a known abdominal aortic aneurysm >4 cm in diameter, a known iliac artery aneurysm >3 cm in diameter, or history of open surgical abdominal aortic or iliac revascularization.
5. Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm;
6. Subject is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus);
7. Acute limb ischemia;
8. History of a bleeding diathesis;
9. History of a hypercoagulability syndrome;
10. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3; a WBC <3,000 cells/mm3; or hemoglobin <10.0 g/dL;
11. Acute or chronic renal dysfunction (creatinine >2.5 mg/dl or >176 µmol/L), or on chronic hemodialysis;
12. Severe liver impairment as defined by total bilirubin =3 mg/dl or two times increase over the normal level of SGOT/AST or SGPT/ALT;
13. Known allergies to the following: aspirin, clopidogrel, prasugrel, ticagrelor, or heparin, contrast agent (that cannot be adequately premedicated), or drugs similar to sirolimus (i.e. tacrolimus, everolimus, zotarolimus) or other macrolides;
14. Subject requires planned procedure within 30 days that would necessitate the discontinuation of clopidogrel, prasugrel, or ticagrelor;
15. Subject is on chronic Coumadin therapy
16. Subject has had or is planned to have treatment with DES or drug coated balloon (DCB) within 90 days pre- or post-index procedure;
17. Subject is non-ambulatory;
18. Subject has undergone percutaneous intervention of the coronary, carotid, or arterial bed exclusive of the <30 days prior to the planned index procedure.
19. Subject has received, or is on the waiting list for, an organ transplant;
20. Subject had a myocardial infarction (MI) within the previous 30 days prior to the planned index procedure;
21. Subject has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limit the subject's ability to walk;
22. Subject has unstable angina defined as rest angina with ECG changes;
23. Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment;
24. Subject has acute thrombophlebitis (superficial or deep) in either extremity;
25. Subject has other medical conditions (e.g., cancer, congestive heart failure or substance abuse) that may cause the subject to be non-compliant with protocol requirements or confound data interpretation;
26. Subject is currently participating or wanting to participate in a clinical trial following 6 months after the index procedure in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials);
27. Subject is unable to understand or unwilling to cooperate with study procedures;
28. Subject has prior minor or major amputation of either lower extremity;
29. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy;
30. Pre-operative plan for additional treatment of the target lesion at the time of the study procedure with alternative therapy such as drug-eluting stent (DES) and scaffold, laser, atherectomy, cryoplasty, cutting balloon, drug-eluting balloon, or brachytherapy (vessel preparation with uncoated balloon angioplasty is allowed); 31Plan for cardiovascular surgical or interventional procedure =30 days after the study procedure including planned treatment of the contralateral lower extremity.

Angiographic exclusion criteria:

1. Target extremity has an angiographically significant (>50% diameter reduction) lesion located in the target vessel distal to the target lesion;
2. Thrombus in the target vessel;
3. Stenosis (>50%) or occlusion of an ipsilateral inflow artery;
4. Angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion, or from crossing or pre-dilating the target lesion;
5. Target lesion has calcification with either of the following characteristics:

* Circumferential orientation, or
* Thickness >2 mm (radially) within the wall of the target lesion.
6. Failure to achieve less than 30% residual stenosis after balloon predilation.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2021
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Steiermark
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Tienen
Country [5] 0 0
Germany
State/province [5] 0 0
Niedersachsen
Country [6] 0 0
Germany
State/province [6] 0 0
NRW
Country [7] 0 0
Germany
State/province [7] 0 0
Freiburg
Country [8] 0 0
Germany
State/province [8] 0 0
Leipzig
Country [9] 0 0
Germany
State/province [9] 0 0
Muenster
Country [10] 0 0
New Zealand
State/province [10] 0 0
Auckland
Country [11] 0 0
New Zealand
State/province [11] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Elixir Medical Corporation
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Syntactx
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Massachusetts General Hospital
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Genae
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marc Bosiers, Doctor
Address 0 0
AZ Sint-Blasius Dendermonde
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT02869087