Prospective, Multi-center, Randomized Controlled Study to Evaluate the Effectiveness and Safety of Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 5
- 主要终点
- Rate of successful hemostasis
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of the suture-mediated closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. following endovascular peripheral arterial procedures.
详细描述
Prospective, multi-center, randomized Comparative study using the Suture-mediated Closure System produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd.as an investigational device and the Perclose® ProGlide Suture-Mediated Closure System as a comparator.
After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two devices. The subjects should follow designated physician's instructions accurately during the clinical trial period. There are about 4 times evaluations Including screening.
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
- •Patients who can use 5Fr to 21Fr sheath for common femoral artery puncture for interventional catheterization or therapy
- •Informed consent signed by the patient or legal representative
排除标准
- •Pregnancy or lactation period;
- •Diameter of femoral artery site for puncture< 5mm;
- •Have participated in another clinical study during the same period;
- •Known allergy to any device component, and/or contraindications of contrast agents and anticoagulants;
- •Vascular injury at the site of the approach;
- •Groin infection;
- •Morbid obesity (BMI≥40kg / ㎡);
- •Ultrasonographic assessment of the entire common femoral artery wall showed that the common femoral artery stenosis was ≥ 50%;
- •There are femoral aneurysms, arteriovenous fistulas or pseudoaneurysms in the common femoral artery;
- •Clamp vessel closures were used at the previous ipsilateral artery approach;
- •Hematoma at ipsilateral artery approach;
- •Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
结局指标
主要结局
Rate of successful hemostasis
时间窗: 10 minutes
Calculation method: Patients with successful hemostasis / total cases of subjects in the same group x 100%. Definition of successful hemostasis: Within 10 minutes after completion of the suturing procedure, there is no bleeding or hematoma at the puncture site, and no other intervention or surgical treatment is required.
次要结局
- Evaluation of Withdrawal performance of the device(Approximately 15-minutes after device removal)
- Operation time(Approximately 15-minutes after device removal)
- Technical success rate(Approximately 15-minutes after device removal)
- Evaluation of Performance of tightening knot of the device(Approximately 15-minutes after device removal)
- Hemostasis time(Approximately 15-minutes after compression)
- Evaluation of Compatibility with guidewires of the device(Approximately 15-minutes after device removal)
- Evaluation of Pushing performance of the device(Approximately 15-minutes after device removal)