IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

Description

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

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Study Overview

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Study Details

Study overview

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.

IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

Condition
Type B Aortic Dissection
Intervention / Treatment

-

Contacts and Locations

Phoenix

Honorhealth, Phoenix, Arizona, United States, 85020

Long Beach

Memorial Care Long Beach Medical Center, Long Beach, California, United States, 90806

Los Angeles

Keck Medical Center of USC, Los Angeles, California, United States, 90033

Aurora

University of Colorado Denver, Aurora, Colorado, United States, 80045

Hartford

Hartford Hospital, Hartford, Connecticut, United States, 06102

New Haven

Yale University, New Haven, Connecticut, United States, 06510

Gainesville

University of Florida Health, Gainesville, Florida, United States, 32608

Tampa

Tampa General Hospital, Tampa, Florida, United States, 33606

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Springfield

Southern Illinois University School of Medicine, Springfield, Illinois, United States, 62702

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age \> 21 years
  • 2. Stanford type B aortic dissection not involving the aorta at or proximal to the innominate artery, without rupture and/or malperfusion (renal, mesenteric, or extremity)
  • 3. Acuity: within 48 hours - 6 weeks of index admission
  • 4. Ability to provide written informed consent and comply with the protocol
  • 5. Investigator believes anatomy is suitable for TEVAR
  • 1. Ongoing systemic infection
  • 2. Pregnant or planning to become pregnant in the next 3 months
  • 3. Life expectancy related to non-aortic conditions \< 2 years
  • 4. Unwilling or unable to comply with all study procedures including serial imaging follow-up
  • 5. Known patient history of genetic aortopathy
  • 6. Penetrating Aortic Ulcer and Intramural hematoma
  • 7. Iatrogenic (traumatic) aortic dissection
  • 8. Prior surgery for aortic dissection

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Manesh R Patel, M.D., PRINCIPAL_INVESTIGATOR, Duke University

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

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

Study Record Dates

2030-06-30