Evaluation of Atherectomy in the Management of Occlusive Lesions of the Common Femoral Arteries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atherectomy.
- Who it may be relevant to
- Registry conditions: Femoral Artery Occlusion, Atheromatous Plaques. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Atherectomy in the Management of Occlusive Lesions of the Common Femoral Arteries (RAFAL)
Overview
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
- Procedure Atherectomy
Two different techniques : rotational atherectomy or thromboendarterectomy
Primary outcome measures
- Local complications [Time frame: one month]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Privé de Villeneuve d'Ascq, — Villeneuve-d'Ascq
Identifiers
NCT: NCT07142330 · RAFAL