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

Led by The University of Texas Health Science Center, Houston · Updated on 2022-01-27

436

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

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.

Research Team

Harleen K Sandhu, MD, MPH

Kristofer M Charlton-Ouw, MD, FACS

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

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria