Bypass versus endovascular treatment for long superficial femoral artery lesions causing claudication

Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant

This trial tests whether femoro-popliteal bypass surgery or an endovascular procedure better keeps 15–25 cm superficial femoral artery blockages open in adults with moderate leg claudication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 290 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 16 sites (Bordeaux and 15 other locations)
• Trial ID: NCT05216731 on ClinicalTrials.gov

What this trial studies

This interventional study directly compares surgical femoro-popliteal bypass with endovascular treatment for long (15–25 cm) lesions of the superficial femoral artery in patients with unilateral Rutherford 2–3 claudication. Eligible patients must be suitable for both procedures and have preserved or restored iliac inflow with at least one patent below-knee artery. Participants will undergo the assigned revascularization and be followed for vessel patency, symptom relief, and complications over planned follow-up visits. The aim is to generate prospective head-to-head data to inform treatment choice for long femoro-popliteal lesions.

Who should consider this trial

Good fit: Adults with unilateral Rutherford 2 or 3 lower extremity arterial disease due to a 15–25 cm TASC C or D lesion of the superficial femoral artery who are eligible for both bypass surgery and endovascular treatment are ideal candidates.

Not a fit: Patients with altered iliac inflow, prior surgery or stent on the affected superficial femoral artery, active bacteremia, pregnancy, breastfeeding, or contraindications to antiplatelet therapy or heparin are unlikely to be eligible or benefit from participation.

Why it matters

Potential benefit: If successful, the trial could identify which procedure provides longer-lasting artery patency and better walking ability, helping doctors choose the best first-line treatment.

How similar studies have performed: There is no dedicated randomized head-to-head trial for these long lesions; retrospective series suggest endovascular patency may be lower than surgery but definitive prospective comparisons are lacking.

Eligibility criteria

Inclusion Criteria:

* Adult patient
* Effective contraception for the duration of research for fertile women of childbearing age
* Unilateral Rutherford 2 or 3 symptomatic Lower Extremity Artery Disease (LEAD) arteritic patient with a lesion of the superficial femoral artery Trans-Atlantic Inter-Society Consensus (TASC) C or D between 15 and 25 cm
* Patient eligible for bypass surgery and endovascular procedure
* No alteration of the upstream flow (iliac flow preserved or restored)
* Patient with at least one patent artery below the knee
* Patient informed and having signed the information and consent form to participate in the study

Exclusion Criteria:

* Known pregnancy or breastfeeding
* Iliac flow altered upstream
* History of surgery or stent on the affected superficial femoral artery
* Concomitant bacteremia (positive blood cultures in the 7 days preceding the procedure)
* Known intolerance to antiaggregants or heparin
* Contraindication to the endovascular procedure (severe renal failure contraindicating the injection of contrast product despite prior hydration, known severe allergy to iodinated contrast product \[unless the center chooses to use carbon dioxide injection\]) or bypass surgery (cardiovascular, respiratory or other comorbidities, contraindicating general anesthesia, local contraindications for bypass: skin lesion at the operative site)
* No affiliation to a social security regime or to another social protection regime
* Patient deprived of liberty or under legal protection (guardianship, trusteeship)
* Inability, according to the investigator, to understand or refusal to sign the informed consent to participate in the study (non-French speaking patient, cognitive disorders)
* Ongoing participation in another research protocol Participation in non-interventional research is authorized

Secondary exclusion criterion:

* Negative opinion from the anesthesiologist-resuscitator at the end of the pre-anesthetic consultation
* Positive pregnancy test from the pre-operative laboratory test (result received after obtaining consent, but before the surgical procedure)

Where this trial is running

Bordeaux and 15 other locations

• CHU - Hôpitaux de Bordeaux — Bordeaux, France (Active_not_recruiting)
• Hôpital Ambroise Paré, APHP — Boulogne-Billancourt, France (Active_not_recruiting)
• Hôpital de la Cavale Blanche — Brest, France (Active_not_recruiting)
• Centre hospitalier René Dubos — Cergy-Pontoise, France (Active_not_recruiting)
• Hôpital Henri Mondor, APHP — Créteil, France (Recruiting)
• Hôpital François Mitterrand — Dijon, France (Recruiting)
• Hôpital Edouard Herriot — Lyon, France (Active_not_recruiting)
• Hôpital de la Timone, APHP — Marseille, France (Not_yet_recruiting)
• CHU de Nice — Nice, France (Active_not_recruiting)
• CHU Carémeau — Nîmes, France (Not_yet_recruiting)
• Hôpital Européen Georges Pompidou, APHP — Paris, France (Active_not_recruiting)
• Hôpital Bichat - Claude Bernard, APHP — Paris, France (Active_not_recruiting)
• Hôpital La Pitié-Salpêtrière, APHP — Paris, France (Not_yet_recruiting)
• CHU de Poitiers — Poitiers, France (Recruiting)
• CHU de Rangueil — Toulouse, France (Active_not_recruiting)
• Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu — Vandœuvre-lès-Nancy, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Joseph TOUMA, MD, PhD

Conditions Lesion; Femoral; Bypass; Endovascular procedure; Long lesions of the superficial femoral artery