New stent procedure offers hope for High-Risk aortic tear patients
NCT ID NCT07405242
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a less invasive treatment for a serious tear in the main artery near the heart, specifically for people who are too high-risk for open-heart surgery. About 149 participants will receive a stent placed through a blood vessel to repair the tear. Researchers will check how safe and effective the procedure is over one year, focusing on survival and major heart or brain complications.
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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 149 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2030
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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65 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Voluntary participation in the clinical trial; The individual fully understands and is informed of this study and has signed the informed consent form; Willing to follow and be able to complete all trial procedures * Age ≥ 65 years old, both male and female are eligible * Confirmed by imaging to be retrograde tear aortic dissection, that is, the tear site is located at the aortic arch or descending aorta, and the retrograde tear involves the ascending aorta. The farthest segment of the dissection tear is ≥ 2 cm from the coronary artery outlet * Evaluation by cardiac surgery indicates that open surgical treatment is not suitable, performing open surgery poses significant risks or the risks outweigh the benefits * Arterial access conditions are permitted, without severe stenosis or distortion, and the stent delivery system can be smoothly introduced; Exclusion Criteria: * Severe organ ischemia or functional failure, which, after assessment, is considered to have an extremely poor prognosis and cannot benefit from endovascular treatment, such as extensive cerebral infarction or cerebral hemorrhage, resulting in irreversible severe neurological deficits, acute extensive ischemic necrosis of the mesenteric arteries, acute liver and kidney failure; * Planned to undergo aortic valve repair/replacement or coronary artery interventional therapy within 30 days; * Mechanical heart valve present at the aortic valve position; * Aortic valve regurgitation degree ≥ 3+ or 4+; * Known severe allergy to contrast agents or stent materials (such as nickel-titanium alloys, polyester, etc.); * Severe systemic infection that may lead to infection after stent implantation; * Severe coagulation dysfunction, which, after correction, still cannot meet the surgical requirements, or has bleeding tendencies; * Complicated with other serious diseases or malignant tumors, with a predicted survival period of less than 12 months; * Pregnant or lactating women; * With mental illness or cognitive impairment, unable to understand and cooperate with the study; * Already participating in other ongoing interventional clinical studies; * Other situations judged by the investigator as not suitable for inclusion in the study;
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Conditions
The condition(s) this trial relates to.
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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Shanghai Jiao Tong University Medical School Affiliated Ruijing Hospital
RECRUITINGShanghai, Shanghai Municipality, 201801, China
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Other studies related to the condition(s) this trial covers.