Ireland
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Active, not recruiting Observational

EndoVascular Aortic Dissection Early vs Delayed

NCT07143071 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2025-07-01
Last updated
2025-08-27

Condition(s) studied

Aortic Dissection Type B

Investigational drug(s) / intervention(s)

Acute PhaseSubacute Phase

Acute Phase: Patients with acute high-risk type B aortic dissection received endovascular treatment in acute phase (2-14days)

Subacute Phase: Patients with acute high-risk type B aortic dissection received endovascular treatment in subacute phase (≥14days)

Study 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 dissection in the acute phase versus the subacute phase. No interventions will be imposed on the patients' standard treatment. Patients with acute high-risk type B aortic dissection will be grouped based on the actual timing of their treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

  • 30-day all-cause mortality rate — 30 days following the operation
    paraplegia, stroke, new entry tear, renal/liver dysfunction, type I/II/R endoleak
  • 30-day complication rate — 30 days following the operation
    access site complications

Trial sites (1)

FacilityCityRegionStatus
Shanghai Zhongshan Hospital Shanghai China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07143071 on ClinicalTrials.gov ↗ ← All trials in China