NCT01849601已完成不适用
A Prospective, Multicenter and Single-arm Target Value Clinical Study on the Efficacy and Safety of Peripheral Balloon Dilatation Catheter in PTA Procedure
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- technical success rate of PTA procedure
研究概览
简要总结
The purpose of this study is to determine whether the peripheral balloon dilatation catheter (trade name: Iris) is safe an effective in PTA procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 yrs - 80 yrs.
- •patients with iliac and / or femoral artery atherosclerotic lesions
- •Rutherford grade of 1-5;
- •Target lesion stenosis≥70% (visual estimation) (proportion of Trans-Atlantic Inter-Society Consensus(TASC) B, C and D grade lesions not less than 60% )
- •Patients being able to understand the purpose of the test, and being volunteered to participate in and sign the informed consent.
排除标准
- •Patients not suitable for receiving interventional surgeries of lower limb arteries for treatment;
- •Patients require intervention of lesions besides unilateral iliac and femoral artery lesions at the same time;
- •Patients have been involved in clinical trials of other drugs or medical devices within the past three months;
- •Patient is unable or unwilling to participate in this trial;
- •Patients with serious heart and brain, liver and other vital organs failure;
- •Patients with life expectancy less than 6 months;
- •Pregnant women.
研究组 & 干预措施
PTA catheter
Experimental
干预措施: percutaneous transluminal angioplasty balloon catheter (Device)
结局指标
主要结局
technical success rate of PTA procedure
时间窗: instant
1. successfully pass lesion(s) 2. successfully dilate lesion(s)( diameter of balloon reach at least 90% of the nominal diameter) 3. successfully retrieve The definition of technical success rate of PTA procedure is that, all of the above 3 point are successful
次要结局
- safety assessment(day 2 to day 10 after procedure or hospital discharge)
研究者
研究点 (1)
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