Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® DCB Catheter) for Conformité Européene (CE) Mark Approval
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Late Lumen Loss (LLL)
研究概览
简要总结
This study will assess the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries of patients with symptomatic PAD.
详细描述
The primary objective of the clinical investigation is to evaluate the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries (SFA/PA) of patients with symptomatic PAD.
The performance of the GORE® DCB Catheter is superior to a performance goal derived from literature reports of uncoated PTA balloons, measured six months after intervention.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PAD patients with Rutherford Class 2 - 4
- •De novo or restenotic lesions, including total occlusions of the SFA/PA
- •1 lesion which may include one or more regions of luminal narrowing ≥70% with a total combined lesion length between 30 - 150mm and a reference vessel diameter of 4 - 6mm
- •1 patent tibial or peroneal artery
排除标准
- •Surgical or endovascular access in the Target limb/vessel within the previous 30 days
- •Prior treatment of the Target lesion with PTA within 90 days or any prior treatment with drug-coated balloon
- •Prior treatment of the Target vessel with stenting or bypass
- •Iliac artery inflow lesions that cannot be successfully treated during the Index procedure
- •Acute or subacute thrombus or arterial aneurysm in Target limb
- •Severe calcification that renders the Target lesion non-dilatable
- •Acute or chronic renal dysfunction (serum creatinine ≥2.5 mg/dL)
结局指标
主要结局
Late Lumen Loss (LLL)
时间窗: Six months
Six month late lumen loss (LLL) is defined as the difference in minimum lumen diameter of the Target lesion between the time points immediately post-intervention and the 6-month follow-up angiography or at the time of a Clinically Driven Target Lesion Revascularization (CD TLR), whichever is earlier.
次要结局
- Number of Subjects With Freedom From Major Adverse Events(30 days)