Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures

NCT07554976 · tracked via the Priya Life Science China tracker

Sponsor

Suzhou Hengruihongyuan Medical Technology Co. LTD

Phase

Not applicable

Started

2025-11-05

Last updated

2026-04-28

Condition(s) studied

Percutaneous Intervention Via Common Femoral Vein

Investigational drug(s) / intervention(s)

SPIDERPerclose ProGlide

SPIDER: 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).

Perclose ProGlide: 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

hemostasis success rate — within 10 minutes post-suturing

Trial sites (1)

Facility	City	Region	Status
Zhongshan Hospital, Fudan University (Lead Site)	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07554976 on ClinicalTrials.gov ↗ ← All trials in China