Femoropopliteal Artery Stenoses or Occlusive Lesions
Conditions
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 Occlusive Lesions.
Interventions
DEVICEdrug coating balloon angioplasty
The subjects underwent drug coating balloon angioplasty to treat femoropopliteal artery stenosis or occlusive lesions
Sponsors
BrosMed Medical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency Rate at 24 months post-procedure | 24 months | — |
| Target Lesion Revascularization (TLR) Rate at 12 amd 24 months post-procedure | 12 months; 24 months | — |
| Device Success Rate | Immediately after procedure | — |
| Change in ABI (ankle-brachial index) from baseline at 12 and 24 months postoperatively | 12, 24 months | — |
| MAEs Rates at 12 Months and 24 Months Post-Procedure | 12, 24 months | MAEs: Include all-cause mortality within 30 days post-procedure, amputation of the treated limb, and clinically driven target vessel revascularization (TVR). |
| Change in Rutherford classification from baseline at 6, 12, and 24 months postoperatively | 6, 12, 24 months | — |
Countries
China
Outcome results
None listed