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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- Enrollment
- 228
- Locations
- 1
- Primary Endpoint
- Incidence of major complications at the access site
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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