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New device aims to fix lingering aortic tears after emergency surgery

NCT ID NCT07402252

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 device designed to repair remaining tears in the aorta after initial emergency surgery for a serious condition called type A aortic dissection. About 198 adults who still have a tear in their aorta after their first surgery will be randomly assigned to either get the new device plus standard care, or just standard care (medication to control blood pressure). The goal is to see if the device helps the aorta heal better and reduces complications over the next year.

What this could mean

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

Active substance
Type A Dissection Total Endovascular Reconstruction System (a device used to repair remaining tears in the aorta)
What this could lead to
If successful, this device could offer a safer, more effective way to treat residual aortic dissections, potentially reducing the need for lifelong medication and preventing future complications.
What could go wrong
This is an early-stage trial with only 198 participants, so results may not apply to everyone. The device is new and carries risks like any surgical procedure, including bleeding or infection.

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 198 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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 years, male or female. 2. Within 90 days of onset of Stanford Type A Aortic Dissection and 30 days post Total Arch Replacement with Frozen Elephant Trunk treatment (assessed via CTA at 30±7 days post open surgery): 1. Presence of any intimal tear in the residual dissection of the thoracic aorta and the false lumen is not completely thrombosed. 2. The intercostal arteries in the segment of the residual thoracic aortic dissection are primarily supplied by the false lumen (number of intercostal arteries supplied by false/mixed lumen \> number supplied by true lumen; only intercostal arteries filled with contrast agent are considered). 3. False lumen volume in the thoracic aorta distal to the frozen elephant trunk stent graft is \>50% of the total aortic lumen volume. 3. Voluntarily participate in this study and provide signed informed consent. Exclusion Criteria: 1. Presence of a proximal anastomotic leak at the frozen elephant trunk site post open surgery. 2. No left subclavian artery revascularization during the open surgery. 3. Presence of severe endoleak, or residual dissection expansion ≥55mm, or distal stent graft-induced new entry. 4. History of myocardial infarction, or stroke (with clear symptoms/signs and culprit lesion), or bowel ischemia within 1 month prior to the procedure. 5. Previous history of descending thoracic or abdominal aortic surgery. 6. Lack of suitable vascular access. 7. Known allergy to components of the study device (e.g., Nitinol) or contrast agent. 8. Renal insufficiency (creatinine \>2.5 times the upper limit of normal) or requiring long-term regular dialysis. 9. Severe liver dysfunction (Child-Pugh Class C). 10. Active bleeding, coagulation disorders, thrombocytopenia (platelet count \<50×109/L), or refusal of blood transfusion. 11. Uncontrolled severe infection and associated sepsis, shock, or multiple organ failure. 12. Life expectancy less than 12 months (due to conditions other than aortic dissection). 13. Known or suspected connective tissue degenerative disease, or family history of aortic dissection. 14. Pregnant or lactating women. 15. Concurrent participation in other drug or medical device clinical studies. 16. Subjects deemed unsuitable for participating the study 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

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, China