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

Starting soon · Early Phase 1

Conditions studied: Femoropopliteal Artery Occlusion

In brief

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.

Key facts

Study ID

NCT07406308

Run by

Peking Union Medical College Hospital

People needed

408

Starts

2026-04-20

Expected to finish

2028-05-30

Last updated by the study team

2026-02-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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/anticoagulant medications, such as aspirin, clopidogrel, or heparin.
• Subject is pregnant or breastfeeding.
• Subject meets one or more of the following conditions: chronic renal insufficiency (SCr ≥ 2.5 mg/dL) or on regular dialysis; cardiovascular or cerebrovascular surgery within the past 1 month; or severe sequelae from a major stroke.
• Subject has a known allergy to nitinol alloy, paclitaxel, or contrast agents.

Where it is running

• Peking Union Medical College Hospital — Beijing, China

Full record on ClinicalTrials.gov

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