Status:
NOT_YET_RECRUITING
A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or Occlusive Lesions.
Lead Sponsor:
BrosMed Medical Co., Ltd
Conditions:
Femoropopliteal Artery Stenoses or Occlusive Lesions
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 Occl...
Eligibility Criteria
Inclusion
- 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:
- Diameter stenosis ≥70% by visual estimation or
- Chronic total occlusion (CTO)
- 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
- 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;
- Patients currently undergoing dialysis or immunosuppressive therapy;
- Presence of detectable thrombus in lower extremity arteries requiring intraoperative thrombolysis;
- History of stroke or ST-elevation myocardial infarction within 6 months prior to procedure;
- Pregnancy or lactation women;
- Currently participation in other drug/medical device clinical trials without completion;
- Patients deemed by the investigator to be unsuitable for participation in this study.
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07187128
Start Date
September 22 2025
End Date
December 30 2028
Last Update
September 22 2025
Active Locations (2)
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1
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
2
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chognqing, China