Can a plug stop artery bleeding faster than pressing down?
NCT ID NCT03923387
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial compares a vascular closure device called MynxGrip to standard manual compression for stopping bleeding after artery procedures. About 300 adults undergoing diagnostic or interventional endovascular procedures will be randomly assigned to one of the two methods. The goal is to see if the device achieves faster hemostasis and reduces complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a vascular closure device called MynxGrip
- What this could lead to
- If it works, this could offer a faster and safer way to seal artery puncture sites after procedures, reducing recovery time.
- What could go wrong
- This is a relatively small trial, and the device may not prove safer or faster than standard manual compression. Risks include bleeding or vascular injury.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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306 people
The number who actually took part.
- Started
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Apr 2019
- Finished
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Oct 2020
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients ≥ 18 years of age; 2. Patients who are able and willing to sign the informed consent form; 3. Patients who agree to follow all study visits and procedures; 4. Patients who plan to receive the diagnostic or interventional endovascular procedures via percutaneous common femoral artery puncture; 5. Patients who are able to walk, as judged by the investigators. Exclusion Criteria: 1. Patients are proved to have clinically significant peripheral vascular disease according to any of the following situations: 1. Patients showing severe claudication after walking less than 200 meters, 2. No palpable pulse on the patients' affected limbs, 3. Patients having received surgical procedures involving the ipsilateral common femoral artery 4. Patients having received percutaneous transluminal angioplasty (PTA), stent placement, or vascular graft in the ipsilateral common femoral artery; 2. Patients with morbid obesity (BMI \> 40 kg/m2); 3. Patients with a myocardial infarction (MI) with acute elevated ST segment ≤24 hours prior to procedure; 4. Patients with the prior procedure in the ipsilateral common femoral artery ≤30 days; 5. Patients having received ipsilateral vascular closure device; 6. Patients with bleeding disorders such as thrombocytopenia (platelet count \< 100,000/ mm3), hemophilia, von Willebrand disease or severe anemia (Hgb \< 10 g/dL, Hct \< 30%); 7. Patients with documented INR \> 1.5 or patients currently receiving glycoprotein IIb/IIIa platelet inhibitors; 8. Patients with symptoms of local infection or inflammation in the groin; 9. Patients who are participating in any other clinical studies on drugs or medical devices at the same time; 10. Patients who are pregnant or in lactation; 11. Patients with known allergy to contrast medium; 12. Patients with known allergy to polyethylene glycol; 13. Patients with treated but still uncontrolled hypertension (systolic pressure\>180 mmHg or diastolic pressure\>110 mmHg); 14. Patients with known autoimmune diseases; 15. Patients who are receiving long-term corticosteroid therapy; 16. Patients with expected life of less than 30 days; 17. Patients with unilateral or bilateral lower-extremity amputation; 18. Patients who can't walk 6 meters (20 steps) without a support for any reason; 19. Patients requiring prolonged length of stay \[For example, the patient will receive the coronary artery bypass grafting (CABG) or the patient plans to receive the CABG ≤30 days after the surgery\]; 20. Patients with mental disorders and cognitive impairment; 21. Patients have participated into this study before; Intra-operative exclusion criteria; 22. Patients with treated but still uncontrolled hypertension (systolic pressure\>180 mmHg or diastolic pressure\>110 mmHg); 23. Patients implanted with a balloon pump inside the aorta; 24. Patients whose common femoral artery is too thin (\<5 mm in diameter); 25. Patients with obviously fibrotic, calcified, or \>50% stenotic femoral artery; 26. Patients having received puncture at other artery than the common femoral artery; 27. Patients having received antegrade puncture; 28. Patients having received arterial puncture at a number of different sites or who are suspected to have received posterior femoral arterial wall puncture; 29. Patients implanted with ipsilateral venous sheath; 30. Surgical findings or complications which the investigators consider may interfere with the patients' participation into the study (For example, the sheath deployment is difficult due to the scar, tortuous vessels, or use of the sheath with the other sizes than 5 Fr, 6 Fr or 7 Fr, or the sheath with the total length of \>15.7 cm); 31. Patients with preexisting hematoma, intraluminal thrombus, pseudoaneurysm, AV Fistula or any type of dissection; 32. Patients requiring prolonged length of stay \[For example, the patient will receive the coronary artery bypass grafting (CABG) or the patient plans to receive the CABG ≤30 days after the surgery\]; 33. Patients who are included in another drug or medical device study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beijing Tiantan Hospital Capitol Medical University
Beijing, 100068, China
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