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New plug could boost aortic repair success

NCT ID NCT07658651

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether adding a special plug (WeFlow-EndoSeal™) to standard stent-graft repair improves outcomes for people with a tear in the aorta's inner layer (type B aortic dissection). About 256 adults with subacute or chronic dissection will be randomly assigned to get the plug plus standard repair or standard repair alone. The main goal is to see if the plug increases the chance of successful treatment at 12 months without raising the risk of serious events like stroke or kidney failure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
WeFlow-EndoSeal™ Aorta Vascular Plug System
What this could lead to
If successful, this plug could make standard aortic repair more effective, reducing complications and improving long-term survival for people with aortic dissection.
What could go wrong
This is an early-stage device trial with 256 participants, so results may not apply broadly. Risks include procedural complications like bleeding, stroke, or device failure.

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 256 people

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

Started

Jun 2026

Expected to finish

Mar 2032

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. Patients aged 18 to 80 years old. 2. Patients are diagnosed with subacute or chronic Stanford Type B aortic dissection and are scheduled to undergo TEVAR. 3. Upon imaging evaluation, The the maximum diameter of the false lumen landing zone where the vascular plug is intended to be deployed shall be in the descending thoracic aorta is ≤ ■■ mm.. 4. Patients have suitable access conditions evaluated by imaging, allowing the steerable catheter delivery systems to enter the false lumen via the iliac artery, infrarenal aorta, or at the level of the renal artery tear. 5. Patients are able to understand the purpose of the trial, participate in this study voluntarily, has signed the informed consent form personally or via their legal representative, and is willing to complete follow-up in accordance with the protocol requirements. Exclusion Criteria: 1. Presence of persistent malperfusion of visceral arterial branches caused by dissection. 2. ■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■. 3. Infectious aortic disease, Takayasu's arteritis, Marfan syndrome (or other connective tissue diseases). 4. Acute systemic infection. 5. History of myocardial infarction, TIA, or stroke within the past 3 months. 6. NYHA Class IV cardiac dysfunction (see Appendix 1 of the protocol) or LVEF \< 30%. 7. Hematologic abnormalities, defined as: leukopenia (WBC \< 3×10⁹/L), anemia (Hb \< 90 g/L); coagulopathy, thrombocytopenia (PLT count \< 50×10⁹/L). 8. Renal insufficiency with serum creatinine \> 221 μmol/L (or 2.5 mg/dL) and/or end-stage renal disease requiring renal dialysis, as determined by the investigator after comprehensive assessment. 9. Severe hepatic insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5× upper limit of normal; serum total bilirubin (STB) \> 2× upper limit of normal. 10. Hypersensitivity to contrast media, materials of the Aorta Vascular Plug, or the delivery system. 11. Female subjects who are pregnant or breastfeeding. 12. Concurrent participation in another clinical trial of drugs or devices. 13. Patients with a life expectancy of less than 12 months (e.g., advanced malignant tumor). 14. Any other medical conditions or abnormalities that, in the investigator's opinion, render the subject ineligible for this study. Intraoperative Angiography Exclusion Criteria After completion of the stent-graft procedure (including implantation of stents for the proximal and/or distal tears as necessary), DSA angiography revealed: 1. Presence of other vascular lesions (e.g., coronary, renal, mesenteric arteries, etc.) requiring intervention, resulting in an impact on the postoperative medical regimen. 2. Proximal Type I endoleak or Type III endoleak. 3. Presence of a tear in the descending aorta above the upper margin of the celiac trunk ostium.

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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

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Contacts and locations

Locations

  • First Medical Center of The Chinese PLA General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100853, China

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