NCT05841836RecruitingNot Applicable
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
Zhejiang Zylox Medical Device Co., Ltd.1 site in 1 country228 target enrollmentStarted: October 26, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 228
- Locations
- 1
- Primary Endpoint
- Incidence of major complications at the access site
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Not Applicable
Navigation and Positioning System for Orthopedic SurgeryPedicle Screw Fixation of SpineNCT04883580Nanjing Tuodao Medical Technology Co., Ltd112
Active, not recruiting
Not Applicable
Quantitative Flow Ratio (QFR) Guided Coronary Artery Bypass Grafting for Patients Undergoing Primary Valve Surgery With Concomitant Coronary Artery DiseasePrimary Valvular Heart Disease With Comorbid Coronary Artery DiseasePlanned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral and/or Aortic Valvular Heart DiseaseNCT03977129Ruijin Hospital792
Completed
Not Applicable
Safety and Efficacy of SINOMED SR for Endovascular Treatment of Acute Ischemic StrokeIschemic Stroke, AcuteBrain DiseasesCerebrovascular DisordersNCT04973332Sinomed Neurovita Technology Inc.218
Completed
Not Applicable
Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial AccessHeart DiseasesAtrial FibrillationNCT06386458Hangzhou NOYA MedTech Co. Ltm.177
Recruiting
Not Applicable
TEOSYAL RHA® 1 for the Correction of Moderate to Severe Tissue Volume Deficiency in the Infraorbital Region in Chinese AdultsInfraorbital HollowsNCT06749587Teoxane SA260