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

Ramsay Générale de Santé

Status: Not yet enrolling

Conditions: Femoral Artery Occlusion; Atheromatous Plaques

Treatments: Procedure: Atherectomy

Study type: Observational

Funder types: Other

Identifiers

NCT07142330

RAFAL

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patient over 18 years of age
• Non-emergency
• Claudicating patient with significant de novo calcified stenosis affecting the common femoral artery, technically eligible for revascularization by thromboendarterectomy or rotational atherectomy
• Surgery planned with either technique
• Patient's consent to participate in the study must be obtained,

Exclusion criteria

• Patient contraindicated for either technique (for surgical or anesthesiological reasons)
• Patient with asymptomatic lesions of the common femoral artery
• Patient with a history of surgery or angioplasty/stenting of the femoral stump
• Patient with occlusion of the ipsilateral common femoral artery or external iliac artery
• Patient with an indication for additional aortofemoral, iliofemoral, femoral-popliteal, or hamstring bypass
• Patient with severe trophic disorders for which a major amputation is considered immediately in addition to revascularization
• Patient objecting to the use of their data

Trial design

120 participants in 1 patient group

Patient with scheduled atherectomy

Treatment:

Procedure: Atherectomy