Suture-mediated Closure System Following Endovascular Peripheral Arterial 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 18-80
• 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

Exclusion criteria

• 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.