Clinical trial NCT05841836: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Arterial Puncture
Lead sponsor: Zhejiang Zylox Medical Device Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of major complications at the access site
timeFrame: 30 days after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Yu Zhao, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Soochow University
name: Hongfei Sang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Jianming Sun, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruian People's Hospital
name: Changsheng Shi, Master
role: PRINCIPAL_INVESTIGATOR
References: