A Comparative Analysis of Mid- to Long-Term Outcomes: Paclitaxel-Coated Balloon With Debulking Ve… (NCT07406308) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
A Comparative Analysis of Mid- to Long-Term Outcomes: Paclitaxel-Coated Balloon With Debulking Versus Paclitaxel-Coated Balloon Alone in the Treatment of Chronic Femoropopliteal Artery Occlusions
China408 participantsStarted 2026-04-20
Plain-language summary
This study aims to compare mid-to long-term outcomes of paclitaxel-coated balloon angioplasty with adjunctive debulking versus paclitaxel-coated balloon angioplasty alone for the treatment of chronic femoropopliteal artery diseases.
Who can participate
Age range
18 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 age 18-85yrs.
* Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
* Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
* Rutherford category 2-5.
* Subject has atherosclerotic de novo, non-stented restenotic, or in-stent restenotic/occlusive lesions in the superficial femoral artery (SFA) and/or popliteal artery (P1 segment).
* Patent inflow artery with stenosis \<30% by visual estimation (or by core lab assessment if available) and at least 1 infrapopliteal artery to the ankle (\<50% diameter stenosis).
* A guidewire has successfully traversed the target treatment segment.
Exclusion Criteria:
* Subject presents with acute arterial embolism or thrombosis requiring thrombectomy or thrombolysis for limb ischemia.
* Subject has arterial occlusion caused by thromboangiitis obliterans (Buerger's disease) or other forms of immune-mediated vasculitis.
* Subject has undergone surgery on the target vessel within the past 3 months, or has experienced repeated failures of endovascular therapy and is deemed unsuitable for further endovascular intervention.
* Subject has an uncontrolled thrombophilia or hypercoagulable state.
* Subject has a severe systemic disease (e.g., malignancy) with a life expectancy of less than 1 year.
* Subject has contraindications or intolerance to antiplatelet/an…
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.