A Prospective, Multicenter, Single Arm, Post-Market Registry Assessing the Clinical Use and Safety of the LUTONIX Drug Coated Balloon Catheter in Femoropopliteal Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 试验地点
- 16
- 主要终点
- Freedom from Target Lesion Revascularization
研究概览
简要总结
The purpose of the registry is to assess the clinical use and safety of the LUTONIX Drug Coated Balloon Catheter in a heterogeneous patient population in real world clinical practice.
详细描述
The registry will enroll patients with claudication or critical limb ischemia due to stenotic lesions in femoropopliteal arteries. All subjects meeting protocol criteria will be treated with the LUTONIX Drug Coated Balloon Catheter for approved indications according to the current Instructions for Use (IFU) and followed clinically for 2 years.
Total enrollment will be approximately 250 subjects at up to 18 sites. Subject follow-up will occur at 1, 6, 12 and 24 months. The primary efficacy endpoint is freedom from target lesion revascularization at 12 months.
The primary safety endpoint is freedom at 30 days from the composite endpoint of target vessel revascularization and target lesion revascularization, major amputation and major reintervention of index limb, and device- and procedure-related death.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥19 years of age
- •Rutherford Clinical Category ≥4
- •Patient or Legally Authorized Representative is willing to provide informed consent and comply with the required follow-up
- •Stenotic or obstructive vascular lesions in femoropopliteal artery(s)
- •Lesion(s) can be treated with available LUTONIX Drug Coated Balloon 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 active phase of another investigational drug or device study
- •Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast
- •Known inadequate distal outflow or planned future (within 30 days) treatment of vascular disease distal to the target lesion
结局指标
主要结局
Freedom from Target Lesion Revascularization
时间窗: 12 months
Freedom from Major Amputation and Major Reintervention of index limb
时间窗: 30 days
Freedom from Target Vessel and Target Lesion Revascularization
时间窗: 30 days
Freedom from device- and procedure-related death
时间窗: 30 days
次要结局
未报告次要终点