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

NCT02622542 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2022-01-27

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Kristofer M Charlton-Ouw, MD, FACS · University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2025-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02622542 on ClinicalTrials.gov