Self-expanding Nitinol Stents of High vs. Low Chronic Outward Force in De-novo Femoropopliteal Occlusive Arterial Lesions (BIOFLEX-COF)

This is an interventional treatment trial for Stent Restenosis Read More

Inclusion Criteria:

Patient related:

1. Subject (or their legal guardian) has read, understood and provided written informed consent, which has been reviewed and approved by the Institutional Review Board.
2. At least 18 years of age.
3. Male, infertile female or female participants of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7-days prior to study procedure.
4. Projected life expectancy of greater than two years.
5. The ability to comply with protocol follow-up requirements and required testing.

Clinical:

1. Lifestyle-limiting claudication or CLI (meeting angiographic entry criteria) affecting a lower extremity (Rutherford stages 2-5). Patients with Rutherford stage 2 are only eligible after unsuccessful conventional and/or medicamentous therapy.
2. Resting ankle-brachial index (ABI) ≤ 0.8 in the study limb.
3. Inflow lesion - if present - has been treated successfully (inflow treatment in same procedure permissible)

Angiographic and Lesion Requirements (assessed intraoperatively):

1. TASC A-D lesions from stenoses /occlusions ≤ 35cm.
2. Popliteal artery is patent 5 cm proximal to the radiographic knee joint line.
3. Reference diameter of 4.0 - 7.0 mm in proximal and distal treatment segments within the SFA.
4. Patent SFA orifice (the proximal 5 mm after femoral bifurcation).
5. At least one patent (<50% stenotic) inflow vessel present, proven angiographically. Study eligibility is given when inflow lesion has been treated successfully (inflow treatment in same procedure permissible). Successful treatment of inflow lesion is defined as <50% stenosis without death or severe vascular complication.
6. At least one patent (<50% stenotic)tibial artery runoff to the ankle present, proven angiographically. Study eligibility is given when runoff vessel lesion has been treated successfully (inflow treatment in same procedure permissible). Successful treatment of inflow lesion is defined as <50% stenosis without death or severe vascular complication.Guidewire has successfully traversed lesion and is within the true lumen of the distal vessel.

Exclusion Criteria:

1. Pregnant and/or breast-feeding women.
2. Lesion length > 35 cm.
3. Flow-limiting occlusive disease of inflow and / or outflow arteries that cannot be treated sufficiently.
4. Previous stenting or femoral bypass surgery in the target vessel.
5. Clinical relevant aneurysmatic disease of the abdominal aorta, ipsilateral femoral arteries or arteries of the knee.
6. Rutherford stage 0, 1 or 6
7. Non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger's disease, vasculitis).
8. Septicaemia.
9. Ischemic stroke within the last three months.
10. Any previously known coagulation disorder, including hypercoagulability
11. Morbid obesity or operative scarring that precludes percutaneous approach (physician's discretion).
12. Contraindication to anticoagulation or antiplatelet therapy.
13. Known allergy to medication or contrast media used in this trial, if pre-treatment is not possible (physician's discretion).
14. Known allergies to stent components (especially Nickel).
15. Severe calcification of the target lesion.
16. Current participation in another clinical research trial, that has not reached its primary endpoint.
17. The patient is institutionalized based on a legal verdict.