RECRUITING

ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy

Description

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.

Study Overview

Study Details

Study overview

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.

A Randomized Controlled Comparative Study on Effectiveness of Endovascular Repair Versus Best Medical Therapy for Acute Uncomplicated Type B Aortic Dissection

ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy

Condition
Distal Aortic Dissection
Intervention / Treatment

-

Contacts and Locations

Houston

Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center, Houston, Texas, United States, 77030

Houston

Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast, Houston, Texas, United States, 77089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center, Houston,

Kristofer M Charlton-Ouw, MD, FACS, PRINCIPAL_INVESTIGATOR, University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston

Study Record Dates

2026-06