Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant (PELI-CAN)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Lesion; Femoral

Treatments: Procedure: Endovascular procedure; Procedure: Femoro-popliteal bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT05216731

APHP191106

Details and patient eligibility

About

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.

Enrollment: 290 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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290 participants in 2 patient groups

Bypass group

Experimental group

Description:

Under general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis).

Treatment:

Procedure: Femoro-popliteal bypass

Endovascular procedure group

Active Comparator group

Description:

Under general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty.

Treatment:

Procedure: Endovascular procedure