EndoVascular Aortic Dissection Early vs Delayed

NCT07143071 | Active Not Recruiting DMC

• 2 other identifiers: B2024-370(2)R2023ZD0504300
• Study Type: observational
• Target: 4,068
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Aortic Dissection Type B

Keywords

aortic dissection; endovascular therapy; timing of intervention

Outcome Measures

Primary Outcomes (2)

• 30-day all-cause mortality rate

  paraplegia, stroke, new entry tear, renal/liver dysfunction, type I/II/R endoleak

  30 days following the operation

• 30-day complication rate

  access site complications

  30 days following the operation

Secondary Outcomes (4)

• Adverse events

  12 months following the operation

• aortic remodeling

  12 months following the operation

• 5-year all-cause mortality rate

  5 years following the operation

• 5-year complication rate

  5 years following the operation

Study Arms (1)

Patients with acute high-risk type B aortic dissection

Acute (2-14 days) high-risk type B aortic dissection (defined by one or more of the following: aortic maximum diameter \>40 mm, primary tear on the lesser curvature, false lumen diameter \>22 mm, entry tear \>10 mm, aortic diameter growth \>5 mm during hospitalization, imaging evidence of visceral malperfusion, haemorrhagic pleural effusion, need for readmission, or recurrent chest pain).

Procedure: Acute Phase; Procedure: Subacute Phase

Interventions

Acute Phase PROCEDURE

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

Patients with acute high-risk type B aortic dissection

Subacute Phase PROCEDURE

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

Patients with acute high-risk type B aortic dissection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Acute (2-14 days) high-risk type B aortic dissection (defined by one or more of the following: aortic maximum diameter \>40 mm, primary tear on the lesser curvature, false lumen diameter \>22 mm, entry tear \>10 mm, aortic diameter growth \>5 mm during hospitalization, imaging evidence of visceral malperfusion, haemorrhagic pleural effusion, need for readmission, or recurrent chest pain).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, 200032, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2030
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

CN (1)