NCT05899478

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 endovascular peripheral arterial procedures.

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.

Conditions

• Percutaneous Intervention Via Femoral Artery

Interventions

Type	Name	Description
DEVICE	Tyknot® Suture-Mediated Closure System	Arterial closure to ensure hemostasis at femoral artery puncture points
DEVICE	Perclose® ProGlide Suture-Mediated Closure System	Arterial closure to ensure hemostasis at femoral artery puncture points

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-01-01
• Completion: 2024-04-01
• First posted: 2023-06-12
• Last updated: 2025-06-25

Locations

5 sites across 1 country: China