The University of Texas Health Science Center, Houston
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 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 pati…
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…
These FDA-approved devices will be used for performing TEVAR in the patients randomized to this arm, in addition to the medical therapy to control blood pressure (BMT)
Optimal medical therapy will be administered to the patients randomized to this arm, involving but not limited to, beta-blockers, etc., to control the blood pressure and pain for stabilizing the patient upon presentation.
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