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

Recruiting now · Not applicable

Conditions studied: Lesion; Femoral

In brief

In lower limb peripheral arterial disease, the stage of intermittent claudication has a prevalence of more than 5% over the age of 60, and affects patients who are often still active. Frequent anatomical lesions are strictures / occlusions of the superficial femoral artery. There is a current low level of evidence for the treatment modalities of long lesions (15-25 cm) of the superficial femoral artery and in particular no clinical trial comparing the femoro-popliteal bypass to the endovascular procedure whose patency in retrospective series. appears lower than that of surgery but nevertheless appears in the European recommendations for first-line treatment, with the absence of a dedicated trial being highlighted.

Key facts

Study ID: NCT05216731
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 290
Starts: 2025-01-20
Expected to finish: 2030-05-20
Last updated by the study team: 2025-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

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

Full record on ClinicalTrials.gov

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