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

Обзор

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.

Вмешательства

• Процедура Femoro-popliteal bypass
  Under general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis).
• Процедура Endovascular procedure
  Under general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty.

Первичные конечные точки

• Primary patency rate at 2 year follow-up. [Срок оценки: 2 year]

Вторичные конечные точки (8)

• Primary patency rate at 1 year follow-up. [Срок оценки: 1 year]
• Secondary patency rate at 1 and 2 years follow-up. [Срок оценки: 1 and 2 years]
• Clinical improvement according to the Rutherford classification (clinical stages of ischemia) at 1, 6, 12 and 24 months [Срок оценки: 1, 6, 12 and 24 months]
• Improvement of the walking perimeter at 1 and 2 years (<200m,> 200m, unlimited) [Срок оценки: 1 and 2 years]
• The increase in the systolic pressure index at discharge from hospital, then at 1, 6, 12 and 24 months (<0.75,> 0.75) [Срок оценки: 1, 6, 12 and 24 months]
• The quality of life measured by the Vascu-Qol 6 to 2 years [Срок оценки: 2 years]
• The treatment burden measured by the Treatment Burden Questionnaire at 6 months [Срок оценки: 6 months]
• Number of participants with adverse events as assessed by hematoma, redo surgery or vascular infection at 2 years [Срок оценки: During 2 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 16 центров

• CHU - Hôpitaux de Bordeaux — Bordeaux
• Hôpital Ambroise Paré, APHP — Boulogne-Billancourt
• Hôpital de la Cavale Blanche — Brest
• Centre hospitalier René Dubos — Cergy-Pontoise
• Hôpital Henri Mondor, APHP — Créteil
• Hôpital François Mitterrand — Dijon
• Hôpital Edouard Herriot — Lyon
• Hôpital de la Timone, APHP — Marseille
• … и ещё 8 центров

Идентификаторы

NCT: NCT05216731 · APHP191106

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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