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

This trial does not accept healthy volunteers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Atherectomy

    Procedure/Surgery

    Two different techniques : rotational atherectomy or thromboendarterectomy

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Patient with scheduled atherectomy1 intervention

Trial outcomes

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.

Time frame
one month

Secondary outcomes

Other outcomes

Sponsors and contacts

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