The Safety and Efficacy of the Suture-Mediated Closure System

Not Applicable

Recruiting

• Conditions: Arterial Puncture; Peripheral Arterial Disease
• Interventions: Device: the Suture-Mediated Closure System; Device: Perclose ProGlide Suture-Mediated Closure System

• Registration Number: NCT05841836
• Lead Sponsor: Zhejiang Zylox Medical Device Co., Ltd.

Brief 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.

Study Timeline

• Study Start: 2022-10-26
• Study First Submitted: 2023-03-31
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-23
• Last Update Submitted: 2023-04-23
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03
• Primary Completion: 2023-05-30
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

• Between 18 years old and 85 years old, randomized
• Patients who can be examined or treated with a common femoral artery puncture interventional catheter using a 5F to 22F sheath tube
• Patient(or their guardians) who submitted a written informed consent for the this trial

Exclusion Criteria

• Known to be pregnant or lactating
• The diameter of femoral artery on the puncture side was less than 5mm
• Patients requiring anterograde puncture approach
• Have participated in or plan to participate in another clinical trial in the same period
• Known allergy to any components of the device, and/or contraindications to contrast agents and anticoagulants
• International normalized ratio (INR) >2.0
• Traumatic vascular injury at the approach site
• Systemic or local groin infection
• Cerebrovascular accident or myocardial infarction within 3 months
• An arterial catheter needs to be placed at the access site
• Morbidly obese (BMI ≥40 kg/m2)
• The entire common femoral artery wall assessed by ultrasound, calcification located in the anterior wall cut, the extent of more than 50% circumferential or common femoral artery stenosis ≥50
• Femoral artery aneurysm, arteriovenous fistula or pseudoaneurysm in common femoral artery
• Using a clip vessel occluder at the past ipsilateral femoral artery access site
• Use of a puncture point occlusion device at the ipsilateral femoral access site within the past 30 days
• Underwent an intervention via ipsilateral femoral artery puncture within the past 30 days or within the next 30 days
• Ipsilateral femoral vein sheath needed to be used
• Evidence of previous common femoral artery surgery on the same side (e.g., inguinal incision)
• Hematoma at ipsilateral arterial access
• Other circumstances that the investigator deemed inappropriate for participation in the trial.femoral artery aneurysm, arteriovenous fistula or pseudoaneurysm in common femoral artery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the Suture-Mediated Closure System	the Suture-Mediated Closure System	Produced by Zhejiang Zylox Medical Device Co., Ltd.
Perclose ProGlide Suture-Mediated Closure System	Perclose ProGlide Suture-Mediated Closure System	Perclose® ProGlide Suture-Mediated Closure System

Primary Outcome Measures

Name	Time	Method
Incidence of major complications at the access site	30 days after the procedure	The number of subjects who experienced major complications as a proportion of the total number of subjects who used the vascular stapler system

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China