EndoVascular Aortic Dissection Early vs Delayed

NCT ID: NCT07143071

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 4068 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2030-07-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Acute Phase

Intervention Type: PROCEDURE

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

Subacute Phase

Intervention Type: PROCEDURE

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

Interventions

Acute Phase

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

Intervention Type: PROCEDURE

Subacute Phase

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhihui Dong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Zhongshan Hospital

Shanghai, , China

Countries

China

Related Links

https://zsaorta.com

Related Info

Other Identifiers

2023ZD0504300

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

B2024-370(2)R

Identifier Type: -

Identifier Source: org_study_id