Study to Evaluate the Safety and Effectiveness of MynxGrip Vascular Closure Device (NCT03923387) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate the Safety and Effectiveness of MynxGrip Vascular Closure Device
China306 participantsStarted 2019-04-24
Plain-language summary
To evaluate the safety and effectiveness of MynxGrip, in hemostasis of common femoral artery puncture site, compared with manual compression hemostasis in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.
Who can participate
Age range
18 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
. Patients ≥ 18 years of age;
. Patients who are able and willing to sign the informed consent form;
. Patients who agree to follow all study visits and procedures;
. Patients who plan to receive the diagnostic or interventional endovascular procedures via percutaneous common femoral artery puncture;
. Patients who are able to walk, as judged by the investigators.
Exclusion criteria
. Patients are proved to have clinically significant peripheral vascular disease according to any of the following situations:
. Patients showing severe claudication after walking less than 200 meters,
. No palpable pulse on the patients' affected limbs,
. Patients having received surgical procedures involving the ipsilateral common femoral artery
. Patients having received percutaneous transluminal angioplasty (PTA), stent placement, or vascular graft in the ipsilateral common femoral artery;
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
Primary Effectiveness Endpoint: Time to Hemostasis
Timeframe: Post procedure (time from the sheath removal to the time to achieving hemostasis)