This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority trial.
The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with PTX drug-coated balloon (control device) in patients with femoropopliteal artery disease.
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
. Subject age ≥ 18
. Subject has been informed on the nature of the study, the duration of the study, agrees to attend follow-up visits, agrees to complete the required testing, agrees to participate, and has signed an informed consent form.
. Rutherford category 2-4 according to the investigator's subjective evaluation
. Subject has a de novo or re-stenosed lesion with ≥ 70 % stenosis documented angiographically
. Target lesion length is ≥ 2 cm and ≤ 20 cm by visual estimate of the treating physician
. Multiple lesions with max. 3 cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion. Total lesion length should not exceed 20 cm
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.
What they're measuring
1
Patency rate (Absence of clinically driven target lesion revascularization)
Timeframe: one year after study procedure (PTA with medical product under investigation or comparator)
. Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation
. Patency of P2 and P3 segment of the popliteal artery and at least one (1) infrapopliteal artery to the ankle (\< 50 % diameter stenosis) in continuity with the femoropopliteal artery
Exclusion criteria
. Failure to successfully cross the target lesion or subintimal target lesion guidewire crossing
. Flow-limiting dissection after pre-dilatation
. Angiographic evidence of severe calcification of the target vessel (contiguous calcification on both sides of the vessel)
. Presence of fresh thrombus in the target lesion
. Presence of aneurysm in the target vessel/s
. Prior vascular surgery (including atherectomy, bypass surgery) of the target limb
. Prior stent in the target lesion
. Stroke or heart attack within 3 months prior to enrollment