KAIZEN: Safety and Effectiveness Evaluation of Peripheral Orbital Atherectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 21
- 主要终点
- Percentage of Subjects With Acute Device Success
研究概览
简要总结
This is a prospective, single-arm, multi-center study designed to evaluate the safety and efficacy of the Orbital Atherectomy System (OAS) for the treatment of adult Japanese subjects with a de novo symptomatic calcified occlusive atherosclerotic lesion in the superficial femoral artery (SFA) and/or popliteal (POP) artery, which would be otherwise ineligible for endovascular therapy due to risk of complication. Study objective is to collect safety and effectiveness data to support potential commercialization of the peripheral OAS device in Japan.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Percentage of Subjects With Acute Device Success
时间窗: At the end of the procedure
The percentage of subjects with the following, post-procedure: 1. ≤50% residual stenosis post OAD + POBA \[Angiographic Core Lab assessed\] and, 2. No OAS-related severe angiographic complications defined as severe dissections (D-F), perforation, or distal emboli requiring additional treatment during the procedure \[CEC adjudicated\].
次要结局
- Change in Lesion Stenosis(Baseline, Post OAD, Post POBA)
- Acute Technical Success(At the end of the procedure)
- Drug Coated Balloon (DCB) Device Success(Within 3 minutes of insertion of DCB)
- Target Vessel Patency(Up to 6 months)
- Rate of Severe Angiographic Complications(At the end of the procedure)
- Change in Ankle Brachial Index (ABI)(Baseline (within 30 days of the clinical treatment), and Post Procedure (after the clinical trial treatment prior to discharge: post procedure ABI was collected on average 1.1 days post clinical trial treatment))
- Acute Procedural Success(72 hours after index procedure)
- Rate of Major Adverse Event (MAE)(30 days and 6 months)
- Change of Rutherford Classification (ITT Population)(Baseline, 30 days and 6 months)
- Change of Rutherford Classification (mITT Population)(Baseline, 30 days and 6 months)