A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch™ Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 333
- 试验地点
- 36
- 主要终点
- Freedom from Major Adverse Events
研究概览
简要总结
The Chocolate Touch study is a randomized, multi-center, prospective, adaptive study, designed to show sufficient safety and effectiveness of the Chocolate Touch™ for use in superficial femoral or popliteal arteries with the intention of obtaining regulatory approval to market this device in the United States
详细描述
The primary objective of the Chocolate Touch study is to demonstrate non-inferior safety and non-inferior effectiveness of the Chocolate Touch™ compared to the Lutonix® drug coated balloon catheter. These data are intended to show safety and effectiveness of the Chocolate Touch sufficient to support regulatory approval to market this device in the United States for use in superficial femoral or popliteal arteries.
Study success is defined as statistical demonstration of the non-inferiority hypothesis tests for both the primary safety and effectiveness hypothesis.
PMA P210039 approval has been granted on 11/04/2022. The study is now in the post-approval phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
Freedom from Major Adverse Events
时间窗: 12 months
Composite of target-limb-related death, major amputation of the target limb, and clinically driven re-intervention of the target limb.
True Drug Coated Balloon Success
时间窗: 12 months
A composite endpoint that requires patients to achieve Primary Patency (Peak systolic velocity ratio \<2.4 without the need for clinically driven target lesion revascularization) in the absence of a clinically driven bail-out stent (core lab adjudicated).
次要结局
- By Duplex Ultrasound Core Lab Review(6, 12, 24, & 36 months)
- By Angiographic Core Lab Review (Acute)(1 hour)
- By Clinical Assessment(6, 12, 24, & 36 months)