Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures

April 21, 2026 updated by: Suzhou Hengruihongyuan Medical Technology Co. LTD

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPIDER
Device: 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).
Active Comparator: Perclose ProGlide
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hemostasis success rate
Time Frame: within 10 minutes post-suturing
within 10 minutes post-suturing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Hengruihongyuan Medical Technology Co. LTD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • SPD02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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