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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VaSecure Drug-Coated Peripheral Balloon Dilatation Catheter | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug coating balloon angioplasty | Device | The subjects underwent drug coating balloon angioplasty to treat femoropopliteal artery stenosis or occlusive lesions |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency Rate at 12 months post-procedure | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success Rate | Immediately after procedure | |
| Primary Patency Rate at 24 months post-procedure | 24 months | |
| Target Lesion Revascularization (TLR) Rate at 12 amd 24 months post-procedure |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Capital Medical University | Beijing | Beijing Municipality | China |
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| 12 months; 24 months |
| Change in Rutherford classification from baseline at 6, 12, and 24 months postoperatively | 6, 12, 24 months |
| 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 | MAEs: Include all-cause mortality within 30 days post-procedure, amputation of the treated limb, and clinically driven target vessel revascularization (TVR). | 12, 24 months |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chognqing | China |
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