Prospective, Multicenter, Randomized Controlled Study to Evaluate the Efficacy and Safety of a Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- hemostasis success rate
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 Percutaneous Common Femoral Vein 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
- •Aged 18 to 80 years
- •Patients eligible for interventional catheter-based examination or treatment via common femoral artery puncture using sheaths sized 5F to 21F
- •Signed by the patient personally or by their legal representative on the Informed Consent Form
排除标准
- •Known pregnancy or lactation period;
- •Diameter of the common femoral artery on the puncture side < 5 mm;
- •Concurrent participation in another clinical research study;
- •Known allergy to any device component, and/or contraindications to contrast agents or anticoagulants;
- •Vascular injury at the access site;
- •Infection of the inguinal puncture site;
- •Morbid obesity (BMI ≥ 40 kg/m²);
- •Lower extremity vascular ultrasound for assessment of common femoral artery stenosis ≥50%;
- •Presence of femoral artery aneurysm, arteriovenous fistula, or pseudoaneurysm in the common femoral artery;
- •Previous use of clip-based vascular closure devices at the ipsilateral arterial access site;
- •Hematoma at the ipsilateral arterial access site;
- •Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
研究组 & 干预措施
SPIDER
干预措施: SPIDER (Device)
Perclose ProGlide
干预措施: Perclose ProGlide (Device)
结局指标
主要结局
hemostasis success rate
时间窗: within 10 minutes post-suturing
次要结局
未报告次要终点