The Safety and Efficacy of the Suture-Mediated Closure System
Peripheral Arterial Disease, Arterial Puncture
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
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
Sites / Locations
- The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
the Suture-Mediated Closure System
Perclose ProGlide Suture-Mediated Closure System
Produced by Zhejiang Zylox Medical Device Co., Ltd.
Perclose® ProGlide Suture-Mediated Closure System