The Safety and Efficacy of the Suture-Mediated Closure System

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Peripheral Arterial Disease, Arterial Puncture

Intervention / Treatment
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* Device: the Suture-Mediated Closure System
* Device: Perclose ProGlide Suture-Mediated Closure System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the Suture-Mediated Closure System<br>Produced by Zhejiang Zylox Medical Device Co., Ltd. | Device: the Suture-Mediated Closure System<br>* To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site<br>|
| Active Comparator: Perclose ProGlide Suture-Mediated Closure System<br>Perclose® ProGlide Suture-Mediated Closure System | Device: Perclose ProGlide Suture-Mediated Closure System<br>* To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |