Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures

Prospective, Multi-center, Randomized Controlled Study to Evaluate the Effectiveness and Safety of Suture-mediated Closure System Following Endovascular Peripheral Arterial 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 endovascular peripheral arterial procedures.

Study Overview

• Status: Completed
• Conditions: Percutaneous Intervention Via Femoral Artery
• Intervention / Treatment: Device: Tyknot® Suture-Mediated Closure System; Device: Perclose® ProGlide Suture-Mediated Closure System

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 (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • The First Affiliated hospital of USTC
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310006
      • Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine
    • Yiwu, Zhejiang, China, 322000
      • The Fourth Affiliated Hospital ,Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18-80
2. Patients who can use 5Fr to 21Fr sheath for common femoral artery puncture for interventional catheterization or therapy
3. Informed consent signed by the patient or legal representative

Exclusion Criteria:

1. Pregnancy or lactation period;
2. Diameter of femoral artery site for puncture< 5mm;
3. Have participated in another clinical study during the same period;
4. Known allergy to any device component, and/or contraindications of contrast agents and anticoagulants;
5. Vascular injury at the site of the approach;
6. Groin infection;
7. Morbid obesity (BMI≥40kg / ㎡);
8. Ultrasonographic assessment of the entire common femoral artery wall showed that the common femoral artery stenosis was ≥ 50%;
9. There are femoral aneurysms, arteriovenous fistulas or pseudoaneurysms in the common femoral artery;
10. Clamp vessel closures were used at the previous ipsilateral artery approach;
11. Hematoma at ipsilateral artery approach;
12. Other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tyknot® Suture-Mediated Closure System; Arterial closure device used is Tyknot® Suture-Mediated Closure System	Device: Tyknot® Suture-Mediated Closure System; Arterial closure to ensure hemostasis at femoral artery puncture points
Active Comparator: Perclose® ProGlide Suture-Mediated Closure System; Arterial closure device used is Perclose® ProGlide Suture-Mediated Closure System	Device: Perclose® ProGlide Suture-Mediated Closure System; Arterial closure to ensure hemostasis at femoral artery puncture points

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful hemostasis	Calculation method: Patients with successful hemostasis / total cases of subjects in the same group x 100%. Definition of successful hemostasis: Within 10 minutes after completion of the suturing procedure, there is no bleeding or hematoma at the puncture site, and no other intervention or surgical treatment is required.	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time	The time for suturing with the vascular closure device. Definition of Operation time: The time it takes for the device to enter the artery, tie the knot, and then be successfully withdrawn from the vessel.	Approximately 15-minutes after device removal
Hemostasis time	The time from the catheter sheath is removed to compression is released and no bleeding occurs at the puncture site	Approximately 15-minutes after compression
Technical success rate	Calculation method: Patients with technical success/ total cases of subjects in the same group x 100%. Definition of Technical success: Successful placement of the device,smooth withdrawal, and completion fo the knot.	Approximately 15-minutes after device removal
Evaluation of Compatibility with guidewires of the device	Scale from 1 point (worst) to 5 points (best)	Approximately 15-minutes after device removal
Evaluation of Pushing performance of the device	Scale from 1 point (worst) to 5 points (best)	Approximately 15-minutes after device removal
Evaluation of Withdrawal performance of the device	Scale from 1 point (worst) to 5 points (best)	Approximately 15-minutes after device removal
Evaluation of Performance of tightening knot of the device	Scale from 1 point (worst) to 5 points (best)	Approximately 15-minutes after device removal

Collaborators and Investigators

• Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SPD01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No