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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hôpital Henri Mondor, APHP
  Créteil, France Recruiting
• Hôpital François Mitterrand
  Dijon, France Recruiting
• CHU de Poitiers
  Poitiers, France Recruiting
• 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

Study contacts

• Study coordinator: Joseph TOUMA, MD, PhD
• Email: joseph.touma@aphp.fr
• Phone: + 33 6 30 03 10 93

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.