A Prospective, Multicenter, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of Interlocking Detachable Coils System for Embolization of Peripheral Arterial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- target vessel occlusion rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of interlocking detachable coils system in the treatment of Chinese patients with embolization of peripheral arterial in comparison with Interlock Fibered IDC Occlusion System
详细描述
This is a prospective, multicenter, open-label, non-inferiority, randomized controlled clinical trial. The plan is to recruit patients with peripheral arterial disease requiring embolization and then perform peripheral arterial embolization based on randomization using devices in the experimental group or control group. This trail will be conducted in a number of experimental institutions in China, and a total of 116 subjects are planned to be enrolled. All subjects were treated with the interlocking detachable coils system and were evaluated during surgery and before discharge from the treatment of experimental or control devices, followed up at 1 month, 3 months, and 6 months after surgery.
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
- 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 18-80 years;
- •Subject diagnosed with peripheral arterial embolization by preoperative imaging (CTA);
- •The target vessel can be embolized in one operation;
- •The visual diameter of the target blood vessel is 5mm-30mm;
- •Subjects or their legal representatives can understand the purpose of the trial, voluntarily participate and sign the written informed consent, and can be followed up.
排除标准
- •Definite allergy, resistance or contraindication to antiplatelet agents, anticoagulants, contrast agents and/or anesthetics;
- •Definite allergy to platinum, tungsten and/or any substance in the test coil;
- •Subjects are not suitable for anesthesia or endovascular surgery, such as those with severe respiratory, heart, lung, liver, kidney disease or coagulation disorders (such as hemophilia);
- •The target vessel has undergone previous surgery and/or major cardiovascular surgery within 3 months;
- •The target aneurysm is dissecting aneurysm, infected aneurysm, ruptured aneurysm, and aneurysm caused by connective tissue disease;
- •Women who are pregnant or breastfeeding;
- •Subjects who are participating in clinical trials of other drugs or devices that have not reached the end point of the trial;
- •The researcher believes that it is not suitable to participate in the trial.
研究组 & 干预措施
group A Interlocking detachable coils system
The coil is designed with mechanical release, which can be recovered and repositioned at any time when the release process meets certain conditions.
干预措施: Interlocking detachable coils system (Device)
group B Interlock Fibered IDC Occlusion System
The coil adopts the design of mechanical release, and can be recovered, repositioned and released at any time when the release process meets certain conditions.
干预措施: Interlock Fibered IDC Occlusion System (Device)
结局指标
主要结局
target vessel occlusion rate
时间窗: 6 months
no blood flow through the occluded segment of the target vessel
次要结局
未报告次要终点