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The Safety and Efficacy of the Suture-Mediated Closure System

Primary Purpose

Peripheral Arterial Disease, Arterial Puncture

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the Suture-Mediated Closure System
Perclose ProGlide Suture-Mediated Closure System
Sponsored by
Zhejiang Zylox Medical Device Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the Suture-Mediated Closure System

Perclose ProGlide Suture-Mediated Closure System

Arm Description

Produced by Zhejiang Zylox Medical Device Co., Ltd.

Perclose® ProGlide Suture-Mediated Closure System

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 31, 2023
Last Updated
April 23, 2023
Sponsor
Zhejiang Zylox Medical Device Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05841836
Brief Title
The Safety and Efficacy of the Suture-Mediated Closure System
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Zylox Medical Device Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Arterial Puncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the Suture-Mediated Closure System
Arm Type
Experimental
Arm Description
Produced by Zhejiang Zylox Medical Device Co., Ltd.
Arm Title
Perclose ProGlide Suture-Mediated Closure System
Arm Type
Active Comparator
Arm Description
Perclose® ProGlide Suture-Mediated Closure System
Intervention Type
Device
Intervention Name(s)
the Suture-Mediated Closure System
Intervention Description
To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site
Intervention Type
Device
Intervention Name(s)
Perclose ProGlide Suture-Mediated Closure System
Intervention Description
To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site
Primary Outcome Measure Information:
Title
Incidence of major complications at the access site
Description
The number of subjects who experienced major complications as a proportion of the total number of subjects who used the vascular stapler system
Time Frame
30 days after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Zhao, Master
Phone
13808338199
Email
820994765@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Zhao, Master
Organizational Affiliation
First Affiliated Hospital of Chongqing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hongfei Sang, M.D.
Organizational Affiliation
Second Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianming Sun, M.D.
Organizational Affiliation
The Second Affiliated Hospital of Chongqing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Changsheng Shi, Master
Organizational Affiliation
Ruian People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Zhao, Master
Phone
13808338199
Email
820994765@qq.com

12. IPD Sharing Statement

Learn more about this trial

The Safety and Efficacy of the Suture-Mediated Closure System

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