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

NCT07142330 | Not Yet Recruiting

• 1 other identifier: RAFAL
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Local complications

  Local complications are defined as follows: hematoma, active bleeding, local infection, thrombosis, delayed healing, false aneurysm, arteriovenous fistula, and neuropathic pain following surgical trauma.

  one month

Study Arms (1)

Patient with scheduled atherectomy

Procedure: Atherectomy

Interventions

Atherectomy PROCEDURE

Two different techniques : rotational atherectomy or thromboendarterectomy

Patient with scheduled atherectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Claudicating patient with significant de novo calcified stenosis affecting the common femoral artery, technically eligible for revascularization by thromboendarterectomy or rotational atherectomy

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramsay Générale de Santé: lead

Study Sites (1)

Hôpital Privé de Villeneuve d'Ascq,

Villeneuve-d'Ascq, 59650, France

Location

MeSH Terms

Conditions

Plaque, Atherosclerotic

Interventions

Atherectomy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Central Study Contacts

Adrien HERTAULT, Dr

CONTACT

0033620055568; adhertault@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: September 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

FR (1)