Evaluation of Atherectomy in the Management of Occlusive Lesions of the Common Femoral Arteries (NCT07142330) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of Atherectomy in the Management of Occlusive Lesions of the Common Femoral Arteries
France120 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.