Self-expanding Nitinol Stents of High vs. Low Chronic Outward Force in De-novo Femoropopliteal Oc… (NCT03097679) | Clinical Trial Compass
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Self-expanding Nitinol Stents of High vs. Low Chronic Outward Force in De-novo Femoropopliteal Occlusive Arterial Lesions
Austria86 participantsStarted 2015-10-01
Plain-language summary
The objective of the BIOFLEX-COF trial is to investigate differences in formation of intimal hyperplasia at one and two years after implantation of nitinol-stents with high vs. low COF in de-novo femoropopliteal occlusive lesions in patients with symptomatic peripheral arterial disease.
The BIOFLEX-COF trial is a prospective, randomized controlled trial. 80 subjects will be enrolled and randomly assigned to either a high COF group (LifeStent Vascular Stent) or low COF group (Pulsar).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject (or their legal guardian) has read, understood and provided written informed consent, which has been reviewed and approved by the Institutional Review Board.
✓. At least 18 years of age.
✓. 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.
✓. Projected life expectancy of greater than two years.
✓. The ability to comply with protocol follow-up requirements and required testing.
✓. 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.
✓. Resting ankle-brachial index (ABI) ≤ 0.8 in the study limb.
✓. Inflow lesion - if present - has been treated successfully (inflow treatment in same procedure permissible)
Exclusion criteria
✕. Pregnant and/or breast-feeding women.
✕. Lesion length \> 35 cm.
✕. Flow-limiting occlusive disease of inflow and / or outflow arteries that cannot be treated sufficiently.