A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or Occlusive Lesions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Primary Patency Rate at 12 months post-procedure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Primary Patency Rate at 12 months post-procedure
时间窗: 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.
次要结局
- 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(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(12, 24 months)