The Safety and Efficacy of the Suture-Mediated Closure System

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05841836
• Other study ID #: Zylox20220321
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: April 2023
• Source: Zhejiang Zylox Medical Device Co., Ltd.
• Contact: Yu Zhao, Master
• Phone: 13808338199
• Email: 820994765[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: July 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Puncture
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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
• 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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Zylox Medical Device Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major complications at the access site	The number of subjects who experienced major complications as a proportion of the total number of subjects who used the vascular stapler system	30 days after the procedure