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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BMT+TEVAR — DEVICE
  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)
• BMT — OTHER
  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.

Study Details

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.

Key Dates

Start date

Oct 1, 2018

Status verified

Jan 2022

Primary completion

Jun 30, 2025

Completion

Jun 30, 2026

Study Design

Enrollment

436 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: BMT Alone
  Patients in this group will be managed with the best medical therapy (BMT) alone
• Experimental: BMT+TEVAR
  Patients in this group will be managed with thoracic endovascular aortic repair (TEVAR) in addition to the best medical therapy (BMT)

Primary Outcome Measure

All-cause mortality [ Time Frame: 5 years ]

Central Contacts

• Harleen K Sandhu, MD, MPH
  7134865131
  [email protected]
• Kristofer M Charlton-Ouw, MD, FACS
  713-486-5100
  [email protected]

Locations (2)

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