New stitch device aims to seal vein holes faster and safer
NCT ID NCT07554976
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new medical device that uses stitches to close the hole in a vein after a catheter procedure. About 136 adults aged 18 to 80 who need vein access for heart or blood vessel treatments will take part. The goal is to see if the device stops bleeding quickly and safely compared to standard methods.
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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About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- 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 to 80 years
- 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. Aged 18 to 80 years 2. Patients eligible for interventional catheter-based examination or treatment via common femoral artery puncture using sheaths sized 5F to 21F 3. Signed by the patient personally or by their legal representative on the Informed Consent Form Exclusion Criteria: 1. Known pregnancy or lactation period; 2. Diameter of the common femoral artery on the puncture side \< 5 mm; 3. Concurrent participation in another clinical research study; 4. Known allergy to any device component, and/or contraindications to contrast agents or anticoagulants; 5. Vascular injury at the access site; 6. Infection of the inguinal puncture site; 7. Morbid obesity (BMI ≥ 40 kg/m²); 8. Lower extremity vascular ultrasound for assessment of common femoral artery stenosis ≥50%; 9. Presence of femoral artery aneurysm, arteriovenous fistula, or pseudoaneurysm in the common femoral artery; 10. Previous use of clip-based vascular closure devices at the ipsilateral arterial access site; 11. Hematoma at the ipsilateral arterial access site; 12. Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhongshan Hospital, Fudan University (Lead Site)
RECRUITINGShanghai, China