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

Overview

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.

Interventions

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

Primary outcome measures

• Primary patency rate at 2 year follow-up. [Time frame: 2 year]

Secondary outcome measures (8)

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

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

France · 16 centers

• 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
• … and 8 more centers

Identifiers

NCT: NCT05216731 · APHP191106

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗