The Safety and Efficacy of the Suture-Mediated Closure System

April 23, 2023 updated by: Zhejiang Zylox Medical Device Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the Suture-Mediated Closure System
Produced by Zhejiang Zylox Medical Device Co., Ltd.
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
Active Comparator: Perclose ProGlide Suture-Mediated Closure System
Perclose® ProGlide Suture-Mediated Closure System
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of major complications at the access site
Time Frame: 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
30 days after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Zylox Medical Device Co., Ltd.

Investigators

  • Principal Investigator: Yu Zhao, Master, First Affiliated Hospital of Chongqing Medical University
  • Principal Investigator: Hongfei Sang, M.D., Second Affiliated Hospital of Soochow University
  • Principal Investigator: Jianming Sun, M.D., The Second Affiliated Hospital of Chongqing Medical University
  • Principal Investigator: Changsheng Shi, Master, Ruian People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2022

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

July 30, 2023

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

April 23, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zylox20220321

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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