Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant
Assistance Publique - Hôpitaux de Paris
290 participants
Jan 20, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria13
- 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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Interventions
Under general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis).
Under general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty.
Locations(16)
View Full Details on ClinicalTrials.gov
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NCT05216731