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

RecruitingNAAges 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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)
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What it tests

  • Femoro-popliteal bypass
  • Endovascular procedure
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Where

16 sites
CHU - Hôpitaux de Bordeaux
Bordeaux, France
Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, France
Hôpital de la Cavale Blanche
Brest, France
Centre hospitalier René Dubos
Cergy-Pontoise, France
Hôpital Henri Mondor, APHP
Créteil, France
Hôpital François Mitterrand
Dijon, France
Hôpital Edouard Herriot
Lyon, France
Hôpital de la Timone, APHP
Marseille, France

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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