A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopli… (NCT07187128) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or Occlusive Lesions.
China150 participantsStarted 2025-09-22
Plain-language summary
T he Purpose of the Study is to evaluation of the Long-Term Safety and Effectiveness of a Drug-Coated Peripheral Balloon Dilatation Catheter in the Treatment of Femoropopliteal Artery Stenoses or Occlusive Lesions.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Aged 18 to 85 years, gender not restricted;
✓. Rutherford grade 2 to 5
✓. Target lesions located in the superficial femoral artery (SFA) and/or proximal popliteal artery requiring percutaneous transluminal angioplasty (PTA), with the following characteristics:
✓. At least one native below-the-knee artery supplying the foot on the affected side preoperatively;
✓. The guidewire can successfully pass through the target lesion site within the vascular lumen;
✓. Agree to participate in this clinical study and voluntarily sign the informed consent form.
Exclusion criteria
✕. Absence of proximal inflow tract or persistent lack of proximal inflow after pretreatment
✕. Type D or higher dissection occurring after target lesion predilation;
✕. Residual diameter stenosis \>50% following target lesion predilation;
✕. Patients with known allergies to aspirin, clopidogrel, heparin, paclitaxel, contrast agents, etc.;
✕. Abnormal function of vital organs (liver/kidney/brain) deemed unsuitable for intervention by investigators;
✕. Documented allergy to aspirin, clopidogrel, heparin, paclitaxel/structural analogs, or contrast agents;