IMPRoving Outcomes in Vascular DisEase - Aortic Dissection

Summary

The goal of this clinical trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection.

Conditions

• Type B Aortic Dissection

Interventions

PROCEDURE

TEVAR

Thoracic endovascular aortic repair

OTHER

Guideline directed medical therapy and surveillance of dissection

Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• State University of New York - Downstate Medical Center

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Duke University

  lead OTHER

Principal Investigators

• Manesh R Patel, M.D. · Duke University

• Firas F Mussa, M.D. · The University of Texas at Houston

• Panos Kougias, M.D. · The State University of New York at Downstate

• Sreekanth Vemulapalli, M.D. · Duke University

• Sean O'Brien, Ph.D. · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-14

Primary Completion

2030-06-01

Completion

2030-06-30

Countries

• United States
• Canada

Study Locations