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NOT YET RECRUITING
NCT07142330

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

Sponsor: Ramsay Générale de Santé

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2025-09-01

Completion Date

2026-09-01

Last Updated

2025-08-26

Healthy Volunteers

No

Interventions

PROCEDURE

Atherectomy

Two different techniques : rotational atherectomy or thromboendarterectomy

Locations (1)

Hôpital Privé de Villeneuve d'Ascq,

Villeneuve-d'Ascq, France