Comparing endovascular repair to best medical therapy for acute type B aortic dissection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of best medical therapy (BMT) alone versus BMT combined with thoracic endovascular aortic repair (BMT+TEVAR) in patients with uncomplicated acute type B aortic dissection. It is a prospective, randomized, controlled trial involving 436 adult participants who will be allocated to one of the two treatment arms. The study will assess all-cause mortality as the primary outcome, along with secondary outcomes related to major morbidity events and quality of life measures. The trial is expected to last approximately 10 years, with a 5-year follow-up for each patient.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
  Houston, Texas, United States Recruiting
• Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Kristofer M Charlton-Ouw, MD, FACS — University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston
• Study coordinator: Harleen K Sandhu, MD, MPH
• Email: Harleen.K.Sandhu@uth.tmc.edu
• Phone: 7134865131

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.