The DESappear Study: Drug Eluting Scaffold (DESappear)

This is an interventional treatment trial for Peripheral Vascular Disease Read More

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.

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.