Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions (NCT02517827) | Clinical Trial Compass
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Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions
Germany306 participantsStarted 2017-08-01
Plain-language summary
The endovascular therapy prevailed in nearly all regions of peripheral artery disease over open surgery techniques. However, in treatment of the common femoral artery vascular surgery is still the gold standard of therapy. One-year patency rates are between 90% and 95%. Today, only in selected cases an endovascular procedure for common femoral artery diseases is recommended.
The primary objective of this study is to compare the performance of directional atherectomy and drug-coated balloon angioplasty over vascular surgery in common femoral artery lesions in a prospective, multi-center, randomized clinical trial.
Who can participate
Age range
21 Years – 85 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
. Subject must be between 21 and 85 years old;
. Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation;
. Clinical diagnosis of symptomatic peripheral artery disease defined by Rutherford 2, 3, or 4;
. Common femoral artery (CFA) stenosis (including CFA bifurcation) \>70% (visual estimate) or occlusion; Additional non-target lesion(s) in remaining non-target vessel(s), except ipsilateral iliac arteries, can be treated at the physician´s discretion;
. At least one vessel outflow (infrapopliteal arteries) to the foot (without stenosis \>50%).
. Endovascular Procedure: successful target lesion crossing of the guidewire (guidewire located intraluminally);
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.
. Non-target lesion interventions (TASC A and B) to restore adequate blood flow, in the same index procedure are allowed. This intervention must be prior to the treatment of the study lesion and successful;
. Willing to comply with the specified follow-up evaluation;
Exclusion criteria
. Ipsilateral significant (\>50%) stenosis of the iliac arteries.
. Significant (\>50%) stenosis of all infrapopliteal arteries, no patent artery to the foot.
. Angiographic evidence of thrombus within target vessel;
. Thrombolysis within 72 hours prior to the index procedure;
. In-Stent restenosis or restenosis of the native common femoral artery.
. Aneurysm in the abdominal aorta or iliac arteries;
. Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy;
. Recent MI or stroke \< 30 days prior to the index procedure;