New combo procedure aims to seal aortic tears more completely
NCT ID NCT07198295
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new way to treat a tear in the aorta (the body's main artery) called type B aortic dissection. The standard repair often leaves small leaks that can cause the artery to widen over time. The new procedure adds a second step: placing small plugs in the false channel to block blood flow and encourage healing. Researchers will follow 72 patients for one year to see if the false channel closes completely and to check for serious complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stent-graft and vascular plugs
- What this could lead to
- If successful, this combined procedure could become a new standard to improve long-term outcomes for type B aortic dissection by promoting complete aortic healing.
- What could go wrong
- This is an early-stage observational study with only 72 participants, so results may not apply broadly. The procedure carries risks like stroke, kidney injury, or paralysis.
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.
- Participants
-
About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Oct 2025
An estimate. Start dates often move.
- Expected to finish
-
Dec 2029
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.
Who is studied
This study will enroll adult patients (aged 18-80 years) diagnosed with acute or subacute uncomplicated type B aortic dissection (TBAD). Participants must exhibit typical clinical and radiological features of TBAD, with distal extension of the dissection to the infrarenal abdominal aorta. All patients are scheduled to undergo elective thoracic endovascular aortic repair (TEVAR) combined with false lumen embolization using vascular plugs. The population excludes individuals requiring emergency intervention, those with complicated dissections (e.g., malperfusion, rupture, or refractory pain), previous aortic surgery, trauma- or infection-related etiologies, significant uncontrolled comorbidities, recent major cardiovascular events, or contraindications to the endovascular procedure. The study aims to include a representative sample suitable for evaluating the safety and efficacy of TEAVR with false lumen embolization under real-world clinical conditions.
- 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 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 Patients must meet all of the following conditions to be enrolled: 1. Diagnosed with acute or subacute (symptom onset ≤30 days) Stanford type B aortic dissection. 2. Present with typical clinical symptoms and imaging-confirmed aortic dissection. 3. Dissection extends distally to involve the infrarenal abdominal aorta. 4. Scheduled to undergo elective TEVAR combined with false lumen embolization. Exclusion Criteria Patients will be excluded if they meet any of the following conditions: 1. Requiring emergency surgery due to rupture, impending rupture, or severe malperfusion. 2. Complicated type B dissection (e.g., visceral/limb ischemia, refractory pain, or hemodynamic instability). 3. Suspected traumatic or infectious etiology of the dissection. 4. Previous history of aortic surgery or endovascular repair. 5. Use of alternative techniques during the procedure (e.g., PETTICOAT, long-segment coverage). 6. Uncontrolled systemic diseases (e.g., severe cardiac/pulmonary/hepatic dysfunction, advanced malignancy, cachexia, or uncorrectable coagulation disorders). 7. Myocardial infarction or stroke within the past 6 months. 8. Age \<18 years or \>80 years. 9. Patient refusal to participate in the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Aortic dissection type B are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.