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

Assistance Publique - Hôpitaux de Paris16 sites in 1 country290 target enrollmentJanuary 20, 2025

ConditionsLesion; Femoral

Overview

Phase: N/A
Intervention: Not specified
Conditions: Lesion; Femoral
Sponsor: Assistance Publique - Hôpitaux de Paris
Enrollment: 290
Locations: 16
Primary Endpoint: Primary patency rate at 2 year follow-up.
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 20, 2025

End Date

May 20, 2030

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Assistance Publique - Hôpitaux de Paris

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Primary patency rate at 2 year follow-up.

Time Frame: 2 year

Primary patency is defined by the presence of satisfactory flow in the superior femoral artery or bypass

Secondary Outcomes

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