Post-marketing Study in Femoral Popliteal Artery of Drug Coated Ballon Used for Treatment of Lower Limb Ischemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 24
- 主要终点
- rate of Clinically-driven TLR
研究概览
简要总结
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
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
- 是
入选标准
- •Age ≥18 years old and ≤85 years old
- •Rutherford clinical category classification：2-5
- •Significant stenosis (≥50%) or occlusions of lesion(s) located in the superficial femoral artery an /or the popliteal artery
- •At least one patent native outflow artery to the ankle free from significant lesion as confirmed by angiography
- •Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.
排除标准
- •Aneurysms near target lesions or popliteal aneurysms.
- •The guide wire cannot pass smoothly through the target lesion.
- •Known allergy to contrast agents, heparin or paclitaxel.
- •Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints or may enroll in other studies after enrollment in this clinical trial.
- •Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating.
- •Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.
研究组 & 干预措施
drug eluting balloon catheter
use drug eluting balloon catheter to treat the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
干预措施: Drug eluting Balloon (Device)
结局指标
主要结局
rate of Clinically-driven TLR
时间窗: 24 months
rate of TLR
时间窗: 24 months
rate of primary patency of target lesion
时间窗: 24 months
rate of procedural success
时间窗: intraoperative
rate of TVR
时间窗: 24 months
rate of SAE
时间窗: 24 months
rate of Major amputation
时间窗: 24 months
rate of device success
时间窗: intraoperative
rate of technical success
时间窗: intraoperative
rate of Clinically-driven TVR
时间窗: 24 months
change in ankle brachial index(ABI)
时间窗: 24 months
rate of All-cause mortality
时间窗: 24 months
rate of target lesion thrombosis
时间窗: 24 months
Rate of adverse events
时间窗: 24 months
change in Rutherford clinical category (target limb)
时间窗: 24 months
rate of Major amputation
时间窗: 12 months
rate of Clinically-driven TVR
时间窗: 12 months
rate of TVR
时间窗: 1 month
rate of SAE
时间窗: 12 months
rate of All-cause mortality
时间窗: 1 month
rate of All-cause mortality
时间窗: 12 months
rate of Major amputation
时间窗: 1 month
rate of target lesion thrombosis
时间窗: 12 months
Rate of adverse events
时间窗: intraoperative
Rate of adverse events
时间窗: 1 month
Rate of adverse events
时间窗: 12 months
rate of TVR
时间窗: 12 months
rate of TLR
时间窗: 12 months
rate of primary patency of target lesion
时间窗: 12 months
rate of Clinically-driven TLR
时间窗: 12 months
rate of TLR
时间窗: 1 month
change in Rutherford clinical category (target limb)
时间窗: 12 months
change in ankle brachial index(ABI)
时间窗: 12 months
次要结局
未报告次要终点