Clinical Trials in China / NCT07187128
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A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or Occlusive Lesions.
NCT07187128 · tracked via the Priya Life Science China tracker
Condition(s) studied
Femoropopliteal Artery Stenoses or Occlusive Lesions
Investigational drug(s) / intervention(s)
drug coating balloon angioplasty
drug coating balloon angioplasty: The subjects underwent drug coating balloon angioplasty to treat femoropopliteal artery stenosis or occlusive lesions
Study 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.
Eligibility
Inclusion Criteria:
1. Aged 18 to 85 years, gender not restricted;
2. Rutherford grade 2 to 5
3. 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)
4. At least one native below-the-knee artery supplying the foot on the affected side preoperatively;
5. The guidewire can successfully pass through the target lesion site within the vascular lumen;
6. Agree to participate in this clinical study and voluntarily sign the informed consent form.
Exclusion Criteria:
1. Absence of proximal inflow tract or persistent lack of proximal inflow after pretreatment
2. Type D or higher dissection occurring after target lesion predilation;
3. Residual diameter stenosis \>50% following target lesion predilation;
4. Patients with known allergies to aspirin, clopidogrel, heparin, paclitaxel, contrast agents, etc.;
5. Abnormal function of vital organs (liver/kidney/brain) deemed unsuitable for intervention by investigators;
6. Documented allergy to aspirin, clopidogrel, heparin, paclitaxel/structural analogs, or contrast agents;
7. Patients currently undergoing dialysis or immunosuppressive therapy;
8. Presence of detectable thrombus in lower extremity arteries requiring intraoperative thrombolysis;
9. History of stroke or ST-elevation myocardial infarction within 6 months prior to procedure;
10. Pregnancy or lactation women;
11. Currently participation in other drug/medical device clinical trials without completion;
12. Patients deemed by the investigator to be unsuitable for participation in this study.
Primary outcome measure(s)
- Primary Patency Rate at 12 months post-procedure — 12 months
12-month primary patency of the target lesion is defined as: absence of clinically driven target lesion revascularization and no Doppler ultrasound-diagnosed target lesion restenosis within 12 months postoperatively. Doppler ultrasound-diagnosed restenosis refers to a peak systolic velocity ratio (PSVR) ≥2.4 at the target lesion (indicating ≥50% luminal stenosis). Clinically Driven: Rutherford classification increase, ABI decrease, or imaging evidence of ≥70% stenosis. Target Lesion Revascularization: Includes any endovascular or open procedure at the target lesion site (e.g., PTA, stent placement, bypass surgery, thrombectomy, thrombolysis) or major amputation of the target limb.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Beijing | Beijing Municipality | |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chognqing |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07187128 on ClinicalTrials.gov ↗ ← All trials in China