Status:
ACTIVE_NOT_RECRUITING
EndoVascular Aortic Dissection Early vs Delayed
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Aortic Dissection Type B
Eligibility:
All Genders
18-80 years
Brief Summary
This is a prospective, multicenter, non-inferior, parallel-controlled observational study. This study aims to compare clinical outcomes of endovascular treatment for acute high-risk type B aortic diss...
Eligibility Criteria
Inclusion
- Acute (2-14 days) high-risk type B aortic dissection.
- Completion of thoracoabdominal aortic CTA before enrollment.
- Ability to understand the study objectives and voluntarily participate, with signed informed consent from the patient or their legal representative.
- Willingness and ability to comply with follow-up visits and study protocols.
Exclusion
- Acute complicated type B aortic dissection.
- Traumatic dissection or penetrating aortic ulcer.
- Connective tissue diseases (e.g., Marfan syndrome, Loeys-Dietz syndrome, Ehlers-Danlos syndrome).
- Pregnancy, women of childbearing potential, or breastfeeding.
- Uncontrolled active infection or active vasculitis.
- Unsuitable access vessels or infection at the access site.
- Endovascular repair requiring ≥2 branch reconstructions.
- Prior aortic surgery (open or endovascular).
- Life expectancy \<2 years.
- Myocardial infarction or cerebrovascular accident within 4 weeks before enrollment.
- Severe gastrointestinal bleeding, major surgery, myocardial infarction, or uncorrected coagulation dysfunction within 6 weeks before enrollment.
- Other conditions deemed by the investigator to compromise the patient's medical interests or unlikely adherence to the study protocol.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2030
Estimated Enrollment :
4068 Patients enrolled
Trial Details
Trial ID
NCT07143071
Start Date
July 1 2025
End Date
July 31 2030
Last Update
August 27 2025
Active Locations (1)
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1
Shanghai Zhongshan Hospital
Shanghai, China, 200032