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New device aims to speed recovery after artery procedures

NCT ID NCT07279220

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 238 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The Second Affiliated Hospital of Army Medical University (PLA)

    Chongqing, 400037, China

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