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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of major complications at the access site