Status:
NOT_YET_RECRUITING
TEAVR With False Lumen Embolization for Aortic Dissection
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Conditions:
Aortic Dissection Type B
Eligibility:
All Genders
18-80 years
Brief Summary
This multicenter, prospective, observational study aims to evaluate the efficacy and safety of thoracic endovascular aortic repair (TEVAR) combined with false lumen embolization using vascular plugs i...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients must meet all of the following conditions to be enrolled:
- Diagnosed with acute or subacute (symptom onset ≤30 days) Stanford type B aortic dissection.
- Present with typical clinical symptoms and imaging-confirmed aortic dissection.
- Dissection extends distally to involve the infrarenal abdominal aorta.
- Scheduled to undergo elective TEVAR combined with false lumen embolization.
- Exclusion Criteria
- Patients will be excluded if they meet any of the following conditions:
- Requiring emergency surgery due to rupture, impending rupture, or severe malperfusion.
- Complicated type B dissection (e.g., visceral/limb ischemia, refractory pain, or hemodynamic instability).
- Suspected traumatic or infectious etiology of the dissection.
- Previous history of aortic surgery or endovascular repair.
- Use of alternative techniques during the procedure (e.g., PETTICOAT, long-segment coverage).
- Uncontrolled systemic diseases (e.g., severe cardiac/pulmonary/hepatic dysfunction, advanced malignancy, cachexia, or uncorrectable coagulation disorders).
- Myocardial infarction or stroke within the past 6 months.
- Age \<18 years or \>80 years.
- Patient refusal to participate in the study.
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT07198295
Start Date
October 1 2025
End Date
December 31 2029
Last Update
September 30 2025
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