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.
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 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.
Parallel
paclitaxel-coated balloon angioplasty
DeviceNo debulking procedures were taken
paclitaxel-coated balloon angioplasty with debulking procedures
DeviceThe patient underwent DCB treatment along with debulking procedures (such as laser or plaque rotational atherectomy, etc.).
1-year primary patency rate
free from clinical-driven target lesion revascularization
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This trial is not recruiting at the moment. You can still explore other options:
