NCT05216731

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lesion; Femoral

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-20
• Primary completion: 2030-03-07
• Completion: 2030-05-20
• First posted: 2022-01-31
• Last updated: 2025-10-03

Locations

16 sites across 1 country: France