NCT01864278已完成不适用
A Prospective, Global Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the LUTONIX Drug Coated PTA Dilatation Catheter
C. R. Bard23 个研究点 分布在 10 个国家目标入组 691 人开始时间: 2012年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 691
- 试验地点
- 23
- 主要终点
- Freedom from Target Lesion Revascularization (TLR)
研究概览
简要总结
The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant female ≥18 years of age;
- •Rutherford Clinical Category ≤ 4;
- •Patient is willing to provide 5-year informed consent and comply with the required follow up;
- •Stenotic or obstructive vascular lesions of the femoropopliteal artery;
- •Lesion(s) can be treated with available LUTONIX Drug Coated PTA Dilatation Catheter device size matrix per current IFU;
- •At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with the LUTONIX Drug Coated PTA Dilatation Catheter).
排除标准
- •Patient is currently participating in an investigational drug or device study;
- •Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast;
- •Pregnant or planning on becoming pregnant or men intending to father a child;
- •Rutherford Class > 4
- •Known inadequate distal outflow or planned future treatment of vascular disease distal to the target lesion
结局指标
主要结局
Freedom from Target Lesion Revascularization (TLR)
时间窗: 12 months
Efficacy: Freedom from TLR at 12 months.
Freedom from Target Vessel Revascularization(TVR), major index limb amputation, and device- and procedure-related death
时间窗: 30 days
Safety: Freedom at 30 days from TVR, major index limb amputation, and device- and procedure-related death
次要结局
未报告次要终点
研究者
研究点 (23)
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