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
Suzhou Hengruihongyuan Medical Technology Co. LTD
136 participants
Nov 5, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria12
- 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.
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Interventions
The intervention utilizes the Vascular Suture System (Model: SPD-100) developed by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd., composed of a vascular suturing device and a suture trimmer. It is intended for closing percutaneous vascular puncture sites in patients undergoing interventional catheter diagnosis or treatment. For femoral artery punctures, it is compatible with 5F-21F sheaths (for sheaths \>8F, at least 2 devices and pre-embedded suture technology are required); for femoral vein punctures, it suits 5F-24F sheaths (for sheaths \>8F, at least 1 device and pre-embedded suture technology are needed).
The intervention employs the Perclose ProGlide Vascular Closure System (Model: 12673) manufactured by Abbott, a clinically validated device for closing percutaneous vascular puncture sites. It is indicated for patients undergoing interventional catheter diagnosis or treatment via femoral artery puncture with 5F-21F sheaths, serving as the control in this prospective, multi-center, randomized controlled trial. The device operates by percutaneously delivering sutures through a guidewire: during or after surgery, it accesses the puncture site, deploys sutures to approximate the vascular wall, and secures the suture knot to achieve hemostasis, with the suture permanently implanted in the body.
Locations(1)
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NCT07554976