New device aims to fix lingering aortic tears after emergency surgery
NCT ID NCT07402252
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
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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 198 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- 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 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.
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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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West China Hospital of Sichuan University
Chengdu, Sichuan, China