Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures

Prospective, Multicenter, Randomized Controlled Study to Evaluate the Efficacy and Safety of a Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures

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.

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.

Inclusion Criteria:

1. Aged 18 to 80 years
2. Patients eligible for interventional catheter-based examination or treatment via common femoral artery puncture using sheaths sized 5F to 21F
3. Signed by the patient personally or by their legal representative on the Informed Consent Form

Exclusion Criteria:

1. Known pregnancy or lactation period;
2. Diameter of the common femoral artery on the puncture side < 5 mm;
3. Concurrent participation in another clinical research study;
4. Known allergy to any device component, and/or contraindications to contrast agents or anticoagulants;
5. Vascular injury at the access site;
6. Infection of the inguinal puncture site;
7. Morbid obesity (BMI ≥ 40 kg/m²);
8. Lower extremity vascular ultrasound for assessment of common femoral artery stenosis ≥50%;
9. Presence of femoral artery aneurysm, arteriovenous fistula, or pseudoaneurysm in the common femoral artery;
10. Previous use of clip-based vascular closure devices at the ipsilateral arterial access site;
11. Hematoma at the ipsilateral arterial access site;
12. Other conditions deemed unsuitable for participation in this clinical trial by the investigator.