The Safety and Efficacy of the Suture-Mediated Closure System

Zhejiang Zylox Medical Device

Status: Enrolling

Conditions: Arterial Puncture; Peripheral Arterial Disease

Treatments: Device: Perclose ProGlide Suture-Mediated Closure System; Device: the Suture-Mediated Closure System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05841836

Zylox20220321

Details and patient eligibility

About

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.

Full 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.

Enrollment: 228 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

the Suture-Mediated Closure System

Experimental group

Description:

Produced by Zhejiang Zylox Medical Device Co., Ltd.

Treatment:

Device: the Suture-Mediated Closure System

Perclose ProGlide Suture-Mediated Closure System

Active Comparator group

Description:

Perclose® ProGlide Suture-Mediated Closure System

Treatment:

Device: Perclose ProGlide Suture-Mediated Closure System