Suture device to close common femoral vein puncture sites

Prospective, Multicenter, Randomized Controlled Study to Evaluate the Efficacy and Safety of a Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures

This tests whether the SPIDER suture closure device is safe and works as well as the Perclose ProGlide for adults having procedures through the common femoral vein.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07554976 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized, multicenter comparative trial that assigns adults to receive either the investigational SPIDER suture-mediated closure system (by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd.) or the marketed Perclose ProGlide device after percutaneous access of the common femoral vein. Eligible participants are adults aged 18–80 undergoing catheter-based procedures using 5F–21F sheaths and who meet entry criteria. Subjects are followed through about four planned evaluations, including screening, the procedure, and post-procedure visits to record hemostasis, complications, and device performance. The trial focuses on safety and effectiveness endpoints comparing the two closure systems.

Who should consider this trial

Good fit: Adults 18–80 scheduled for catheter-based procedures via the common femoral vein using 5F–21F sheaths who can provide informed consent are ideal candidates.

Not a fit: Patients who are pregnant or breastfeeding, have a femoral vessel diameter under 5 mm, active groin infection, significant femoral artery disease (≥50% stenosis, aneurysm, AV fistula, or pseudoaneurysm), morbid obesity (BMI ≥40), known allergy to device components, or who are enrolled in another clinical study are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the device could offer a reliable option for closing femoral puncture sites with faster hemostasis, fewer access-site complications, and quicker recovery.

How similar studies have performed: Other suture-mediated closure systems such as the Perclose ProGlide are widely used and have demonstrated effectiveness, but the SPIDER device is investigational and is being directly compared to Perclose.

Eligibility criteria

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.

Where this trial is running

Shanghai

• Zhongshan Hospital, Fudan University (Lead Site) — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Fu Weiguo Fu

Conditions Percutaneous Intervention Via Common Femoral Vein