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

NCT ID: NCT07142330

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-09-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient with scheduled atherectomy

Atherectomy

Intervention Type: PROCEDURE

Two different techniques : rotational atherectomy or thromboendarterectomy

Interventions

Atherectomy

Two different techniques : rotational atherectomy or thromboendarterectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ramsay Générale de Santé

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Privé de Villeneuve d'Ascq,

Villeneuve-d'Ascq, , France

Countries

France

Central Contacts

Adrien HERTAULT, Dr

Role: CONTACT

adhertault@hotmail.com

0033620055568

Facility Contacts

Adrien HERTAULT, Dr

Role: primary

adhertault@hotmail.com

+33620055568

Other Identifiers

RAFAL

Identifier Type: -

Identifier Source: org_study_id