A Randomized Controlled Comparative Study on Effectiveness of Endovascular Repair Versus Best Medical Therapy for Acute Uncomplicated Type B Aortic Dissection
The University of Texas Health Science Center, Houston
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 pati…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceBMT+TEVAR
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)
- OtherBMT
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.
Locations (2)
- Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical CenterHouston, Texas
- Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital SoutheastHouston, Texas