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NCT Number: NCT07143071

EndoVascular Aortic Dissection Early vs Delayed

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Zhongshan Hospital

Shanghai, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acute Phase

Procedure

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

Subacute Phase

Procedure

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

Primary outcomes

  1. 30-day all-cause mortality rate

    Time frame: 30 days following the operation

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

  2. 30-day complication rate

    Time frame: 30 days following the operation

    access site complications

Secondary outcomes

  1. Adverse events

    Time frame: 12 months following the operation

    rupture, stent-induced new entry, ischemia (renal/limb/intestinal/spinal), endoleak, dissection aneurysm, stroke, venous thrombosis, all-cause death.

  2. aortic remodeling

    Time frame: 12 months following the operation

    aortic diameter growth > 5 mm in 12 months; dissection aneurysm

  3. 5-year all-cause mortality rate

    Time frame: 5 years following the operation

    long-term outcome

  4. 5-year complication rate

    Time frame: 5 years following the operation

    long-term outcome

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

Endovascular Treatment for Acute High-risk Type B Aortic Dissection in Acute VS Subacute Phase: a Prospective, Multicenter, Non-inferior, Parallel Controlled Trial

Acronym: EVADE

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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