ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy (ACUTE-B)

  • STATUS
    Recruiting
  • End date
    Jun 24, 2026
  • participants needed
    436
  • sponsor
    The University of Texas Health Science Center, Houston
Updated on 24 March 2022

Summary

The purpose of the study is to conduct a randomized controlled trial comparing best medical therapy (BMT) alone to BMT with thoracic endovascular aortic repair (BMT+TEVAR) for uncomplicated acute type B aortic dissection.

Description

Study Design:

This is a prospective, two-arm, parallel-group, single-center, pragmatic, randomized clinical trial.

Population

The target population comprises all adult patients aged 18 years and older who present with uncomplicated acute type B aortic dissection. The study sample will include 436 subjects of both genders and any race or ethnicity.

Procedures

Eligible and consented patients will be enrolled into the study if all eligibility criteria are met and will be randomly allocated to one of the two study arms: BMT vs BMT+TEVAR

Study Duration:

The study is expected to accrue patients over the course of 5 years and total follow up per patient for 5 years. Overall duration of the study is anticipated to be about 10 years for completion of all study endpoints.

Endpoints
  • Primary Outcome: To determine all-cause mortality among both study arms.
  • Secondary Outcomes: To assess any major morbidity events (rupture, aortic intervention or reintervention, progression to complicated dissection, aneurysm formation, malperfusion resulting in organ failure, and aorta-specific mortality), as will quality of life measures, temporal discounting assessment and outcomes comparison in an observational cohort of patients who decline to be randomized due to a strong treatment preference.

Risks and Benefits:

Since this study involves only usual care and FDA-approved treatments, the investigators do not expect any additional physical risks to patients beyond those associated with usual care. One discernible risk involved in study participants is an unintentional disclosure of sensitive patient health information.

The participants of this study do not stand to benefit directly from taking part. However, the investigators hope that the results obtained from this study would provide useful information that would help delineate a standard and economical management protocol for acute Type B aortic dissection in future.

Details
Condition Distal Aortic Dissection, Dissection, Aortic Acute, Acute Type B Aortic Dissection (Uncomplicated)
Treatment BMT+TEVAR, BMT, BMT
Clinical Study IdentifierNCT02622542
SponsorThe University of Texas Health Science Center, Houston
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged ≥18 years, regardless of race or ethnicity
Diagnosed with uncomplicated ABAD, i.e., a primary entry tear distal to left subclavian artery with no evidence of malperfusion, end-organ ischemia, rupture, or intractable pain, and onset of symptoms is ≤30 days prior to enrollment
Patient has been stabilized after the acute event with control of pain and blood pressure using ≤3 intravenous antihypertensive medications
Adequate imaging, e.g., CT with contrast (chest + abdomen+ pelvis) is available prior to enrollment; and
Indicates willingness to comply with the study protocol and is able to provide a written informed consent
Meets criteria for inclusion in the National Death Index and Social Security Death Master File

Exclusion Criteria

Diagnosed with Type A aortic dissection
Evidence of complicated ABAD
Chronic Type B aortic dissection (>6 weeks from onset of symptoms)
Unable to be randomized and undergo treatment according to protocol within 30 days of symptom onset
Diagnosed with traumatic dissection or penetrating ulcer
Anatomy is not suitable for TEVAR
Previous descending thoracic or abdominal aortic surgery (open or endovascular)
Unsuitable access sites, including infection at access sites
Associated aortic aneurysm (descending aortic diameter ≥5.0 cm)
Life expectancy <2 years
Unable or unlikely to comply with BMT
Unable or refuse to comply with follow-up
Intend to participate in another trial within 3 months of enrollment
Pregnant or breast-feeding
Vasculitis or known genetic connective tissue disorder (Marfan's syndrome or Ehlers-Danlos syndrome)
Active systemic infection
Chronic kidney disease stage 3-5 (estimated glomerular filtration rate <60 mL/min/1.73m2)
Cerebral vascular accident within past 3 months; or
Clinically significant gastrointestinal bleeding, major surgery, myocardial infarction, or untreated coagulopathy within past 6 weeks
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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