The Safety and Efficacy of the Suture-Mediated Closure System (NCT05841836) | Clinical Trial Compass
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The Safety and Efficacy of the Suture-Mediated Closure System
China228 participantsStarted 2022-10-26
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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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 a…
What they're measuring
1
Incidence of major complications at the access site