Clinical Trial

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

Study acronym: RAFAL
Not Yet Recruiting
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Record status
This record was last updated August 26, 2025 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07142330
Lead Sponsor GCS Ramsay Santé pour l'Enseignement et la Recherche
Conditions Femoral Artery Occlusion, Atheromatous Plaques
Enrollment 120 participants
Start Date 2025-09-01
Primary Completion 2026-05-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-26