Suture-Mediated Closure System 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

• 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

Exclusion criteria

• 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.