NCT05841836

The Safety and Efficacy of the Suture-Mediated Closure System

A Prospective, Multi-center, Randomized Controlled, Non-inferiority Clinical Trial of the Safety and Efficacy of the Suture-Mediated Closure System for Percutaneous Closure of the Common Femoral Artery Puncture Site

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Zhejiang Zylox Medical Device Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This was a prospective, multicenter, randomized, controlled, non-inferiority clinical study with the primary objective of validating the safety and efficacy of the Suture-Mediated Closure System for percutaneous closure of the common femoral artery puncture site.

Detailed description

This study was a prospective, multicenter, randomized, controlled, non-inferiority clinical trial. It is planned to be conducted in multiple clinical trial institutions and enroll 228 subjects. Eligible subjects were randomly divided into the experimental group or the control group at a ratio of 1:1.

Conditions

• Peripheral Arterial Disease
• Arterial Puncture

Interventions

Type	Name	Description
DEVICE	the Suture-Mediated Closure System	To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site
DEVICE	Perclose ProGlide Suture-Mediated Closure System	To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site

Timeline

• Start date: 2022-10-26
• Primary completion: 2023-05-30
• Completion: 2023-07-30
• First posted: 2023-05-03
• Last updated: 2023-05-03

Locations

1 site across 1 country: China