Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07142330
Acronym
RAFAL
Enrollment
120
Registered
2025-08-26
Start date
2025-09-01
Completion date
2026-09-01
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atheromatous Plaques, Femoral Artery Occlusion

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.

Interventions

PROCEDUREAtherectomy

Two different techniques : rotational atherectomy or thromboendarterectomy

Sponsors

Ramsay Générale de Santé
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

France

Contacts

Primary ContactAdrien HERTAULT, Dr
adhertault@hotmail.com0033620055568

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026