Actively Recruiting
Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures
Led by Suzhou Hengruihongyuan Medical Technology Co. LTD · Updated on 2026-04-28
136
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the effectiveness and safety of the suture-mediated closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. following Percutaneous Common Femoral Vein Procedures.
CONDITIONS
Official Title
Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Patients eligible for interventional catheter examination or treatment via common femoral artery puncture using 5F to 21F sheaths
- Signed informed consent by the patient or their legal representative
You will not qualify if you...
- Known pregnancy or breastfeeding
- Diameter of the common femoral artery on the puncture side less than 5 mm
- Participation in another clinical study
- Allergy to any device components or contraindications to contrast agents or anticoagulants
- Vascular injury at the access site
- Infection at the inguinal puncture site
- Morbid obesity with BMI 40 kg/m² or higher
- Common femoral artery stenosis of 50% or more as assessed by ultrasound
- Presence of femoral artery aneurysm, arteriovenous fistula, or pseudoaneurysm
- Previous use of clip-based vascular closure devices at the same arterial access site
- Hematoma at the same arterial access site
- Other conditions judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University (Lead Site)
Shanghai, China
Actively Recruiting
Research Team
F
Fu Weiguo Fu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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