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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRamsay Générale de Santé

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Atherectomy

Treatment groups

120 Participants
are divided into 1 treatment group

Sponsors and collaborators