Not Yet RecruitingNot Applicable

DRug-Eluting BallOOn Versus Primary Polymer-coated Paclitaxel Eluting STenting for Femoro-popliteal Lesions

France402 participantsStarted 2025-05

Plain-language summary

Main objective of the study: To demonstrate that a primary DCB strategy is non-inferior in terms of primary patency to a primary SEDES strategy for above-the-knee femoro-popliteal lesions at 12 months. Primary endpoint: Freedom from loss of primary patency at 12 months: loss of primary patency will be defined as the need for target vessel revascularization and/or binary restenosis (defined as \>70% in diameter or peak systolic velocity \>2.4 m/sec at duplex examination). Secondary objectives: To demonstrate that a primary DCB strategy is non-inferior to a primary SEDES strategy in terms of: * Intra-operative technical success. * Safety at 1, 6, 12, 18 and 24 months. * Primary patency at 1, 6, 12, 18 and 24 months. * Assisted primary patency at 1, 6, 12, 18 and 24 months. * Secondary patency at 1, 6, 12, 18 and 24 months. * All target vessel revascularization at 1, 6, 12, 18 and 24 months. * Clinically-driven target vessel revascularization at 1, 6, 12, 18 and 24 months. * All TLR at 1, 6, 12, 18 and 24 months. * Clinically-driven TLR at 1, 6, 12, 18 and 24 months. * All target extremity revascularization at 1, 6, 12, 18 and 24 months. * Number of secondary interventions at 1, 6, 12, 18 and 24 months. * Binary restenosis at 1, 6, 12, 18 and 24 months. * Mean Rutherford category at 1, 6, 12, 18 and 24 months. * Mean ABI value at 1, 6, 12, 18 and 24 months. * Absolute claudication distance improvement at 1, 6, 12, 18 and 24 months. * Quality of life at 1, 6, 12, 18 and 24 months. * Cost at 1, 6, 12, 18 and 24 months.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject age ≥ 18 * Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form. * Rutherford category 2-4. * Femoro-popliteal stenosis/occlusion * Target lesion is below the origin of the profunda femoris and does not exceed the medial femoral epicondyle. * Patent inflow artery (\<30% diameter stenosis). * Patency of at least one infrapopliteal artery to the ankle (\<30% diameter stenosis) in continuity with the native femoropopliteal artery. Exclusion Criteria: * Inability to obtain informed consent. * Life expectancy \<24 months. * Pregnancy or breastfeeding during study period. * Known clotting disorders. * Contraindication to antiplatelet therapy or anticoagulants. * Known hypersensitivity to nitinol or paclitaxel. * Enrollment into another study. * Significant iliac or common femoral stenosis (\<30% diameter) requiring intervention during the index procedure. * In-stent restenosis * Total occlusion non-crossable by a guidewire. * Acute thrombosis of target vessel * Prior ipsilateral femoro-popliteal bypass. * Implantation of a drug-eluting stent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Loss of primary patency

Timeframe: at 12 months

Trial details

NCT IDNCT06835660

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-11

Contact for this trial

Raphaël COSCAS, MD, PhD

+ 33 1 49 09 55 85 raphael.coscas@aphp.fr

View on ClinicalTrials.gov More Femoropopliteal Lesion trials