RecruitingNot Applicable

Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures

China136 participantsStarted 2025-11-05

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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%;

What they're measuring

hemostasis success rate

Timeframe: within 10 minutes post-suturing

Trial details

NCT IDNCT07554976

SponsorSuzhou Hengruihongyuan Medical Technology Co. LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-01

Contact for this trial

Fu Weiguo Fu

13801760929 fu.weiguo@zs-hospital.sh.cn

View on ClinicalTrials.gov More Percutaneous Intervention Via Common Femoral Vein trials