NCT07142330

Evaluation of Atherectomy in the Management of Occlusive Lesions of the Common Femoral Arteries

Evaluation of Atherectomy in the Management of Occlusive Lesions of the Common Femoral Arteries (RAFAL)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Ramsay Générale de Santé · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Thromboendarterectomy is the standard technique for the treatment of symptomatic occlusive lesions of the common femoral artery. It consists of surgically controlling the artery and interrupting circulation, opening the vessel and removing the atherosclerotic plaque. However, this technique is associated with healing difficulties, postoperative infections, and debilitating incisional pain. The rise of endovascular therapies, particularly at the coronary level, has led to the emergence of new deocclusion techniques, including rotational atherectomy. This technique relies on the use of an intravascular catheter that reams out the atherosclerotic plaque while re-aspirating the resulting debris. A few studies have examined the use of rotational atherectomy for occlusive lesions of the common femoral arteries, but have not evaluated its results compared to the standard treatment. The aim of this multicenter cohort is to describe the efficacy and safety of rotational atherectomy and the standard treatment, thromboendarterectomy, in symptomatic occlusive lesions affecting the common femoral artery.

Conditions

• Femoral Artery Occlusion
• Atheromatous Plaques

Interventions

Type	Name	Description
PROCEDURE	Atherectomy	Two different techniques : rotational atherectomy or thromboendarterectomy

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-05-01
• Completion: 2026-09-01
• First posted: 2025-08-26
• Last updated: 2025-08-26

Locations

1 site across 1 country: France