New device aims to speed recovery after artery procedures
NCT ID NCT07279220
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new medical device designed to stop bleeding from the femoral artery after a catheter procedure. About 238 adults will be randomly assigned to receive either the new device or an existing one. The goal is to see if the new device is safe and effective, and whether it helps patients get out of bed and go home sooner.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vascular closure device (a medical device used to seal the puncture site in the femoral artery after a catheter procedure)
- What this could lead to
- If successful, this could provide a safer and more effective way to stop bleeding after femoral artery procedures, potentially reducing recovery time and hospital stays.
- What could go wrong
- This is an early-stage trial with only 238 participants, so results may not apply to all patients. The device may not work better than existing options, and there is a risk of bleeding or other complications.
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 238 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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May 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. Age 18\~80, male or non-pregnant female; 2. Subjects undergoing interventional diagnostic or therapeutic procedures via femoral artery puncture; 3. Subjects using 5F to 8F sheaths during the procedure (Note: Subjects using 5F-7F sheaths will enter the main randomized controlled cohort, while subjects using 8F sheaths will directly enter the single-arm observational cohort); 4. Subjects or their legally authorized representatives can understand the purpose of the trial, voluntarily participate in the trial and sign informed consent form, and be able and willing to comply with follow-ups and related procedures. Exclusion Criteria: 1. Subjects with femoral artery occlusion or visually estimated lumen diameter \<5mm; 2. Subjects with prior surgical procedures, percutaneous transluminal angioplasty (PTA), stent placement, or vascular grafts at the access site; 3. Subjects with visible calcification at the access site, clinically significant peripheral vascular disease (requiring intervention), or stent implantation ≤1cm from the puncture site; 4. Subjects whose puncture site is above the lowest edge of the inferior epigastric artery and/or above the inguinal ligament as identified by skeletal markers; 5. Subjects with posterior wall vascular puncture or multiple femoral artery punctures due to difficulty in obtaining vascular access; 6. Patients with pathological obesity (BMI \>40 kg/m²); 7. Subjects with pre-existing access site complications (hematoma, pseudoaneurysm, arteriovenous fistula, dissection, etc) or any procedure-related complications that may affect recovery, ambulation, or discharge timing; 8. Subjects with acute ST-segment elevation myocardial infarction within 48 hours prior to the procedure; 9. Subjects with uncontrolled hypertension during closure (Systolic BP \>180 mmHg or Diastolic BP \>110 mmHg); 10. Subjects who are known to be contraindicated or allergic to iodine-containing contrast agents or polyethylene glycol materials; 11. Subjects with severe thrombocytopenia (Platelet count \<30×10⁹/L), hemophilia, von Willebrand disease, or severe anemia (Hemoglobin \<10 g/dL, Hematocrit \<30%); 12. International normalized ratio (INR) \>1.5; 13. Subjects with systemic infection or skin infection at the puncture site, or planned indwelling sheath; 14. Subjects unable to ambulate 6 meters without assistance; 15. Pregnant or lactating women; 16. Subjects currently participating in other drug/device clinical trials; 17. Other subjects deemed ineligible for 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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The Second Affiliated Hospital of Army Medical University (PLA)
Chongqing, 400037, China
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