NCT02622542

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 436 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 patients over the course of 5 years and total follow up per patient for 5 years. Overall duration of the study is anticipated to be about 10 years for completion of all study endpoints. Endpoints: * Primary Outcome: To determine all-cause mortality among both study arms. * Secondary Outcomes: To assess any major morbidity events (rupture, aortic intervention or reintervention, progression to complicated dissection, aneurysm formation, malperfusion resulting in organ failure, and aorta-specific mortality), as will quality of life measures, temporal discounting assessment and outcomes comparison in an observational cohort of patients who decline to be randomized due to a strong treatment preference. Risks and Benefits: Since this study involves only usual care and FDA-approved treatments, the investigators do not expect any additional physical risks to patients beyond those associated with usual care. One discernible risk involved in study participants is an unintentional disclosure of sensitive patient health information. The participants of this study do not stand to benefit directly from taking part. However, the investigators hope that the results obtained from this study would provide useful information that would help delineate a standard and economical management protocol for acute Type B aortic dissection in future.

Conditions

• Distal Aortic Dissection
• Dissection, Aortic Acute
• Acute Type B Aortic Dissection (Uncomplicated)

Interventions

Type	Name	Description
DEVICE	BMT+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)
OTHER	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.

Timeline

• Start date: 2018-10-01
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2015-12-04
• Last updated: 2022-01-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study