RECRUITING

IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

Quick Facts

Study Start:2024-04-14
Study Completion:2030-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06087029

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \> 21 years
  2. 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. 3. Acuity: within 48 hours - 6 weeks of index admission
  4. 4. Ability to provide written informed consent and comply with the protocol
  5. 5. Investigator believes anatomy is suitable for TEVAR
  1. 1. Ongoing systemic infection
  2. 2. Pregnant or planning to become pregnant in the next 3 months
  3. 3. Life expectancy related to non-aortic conditions \< 2 years
  4. 4. Unwilling or unable to comply with all study procedures including serial imaging follow-up
  5. 5. Known patient history of genetic aortopathy
  6. 6. Penetrating Aortic Ulcer and Intramural hematoma
  7. 7. Iatrogenic (traumatic) aortic dissection
  8. 8. Prior surgery for aortic dissection

Contacts and Locations

Study Contact

Megan Roebuck, M.S.
CONTACT
919-316-0628
megan.roebuck@duke.edu
Jacqueline Huvane, Ph.D.
CONTACT
919-668-8282
jacqueline.huvane@duke.edu

Principal Investigator

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 Locations (Sites)

Honorhealth
Phoenix, Arizona, 85020
United States
Memorial Care Long Beach Medical Center
Long Beach, California, 90806
United States
Keck Medical Center of USC
Los Angeles, California, 90033
United States
University of Colorado Denver
Aurora, Colorado, 80045
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
Yale University
New Haven, Connecticut, 06510
United States
University of Florida Health
Gainesville, Florida, 32608
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Northwestern University
Chicago, Illinois, 60611
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Indiana University Methodist Hospital
Indianapolis, Indiana, 46202
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
MaineHealth
Scarborough, Maine, 04101
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Michigan Health
Ann Arbor, Michigan, 48109
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
Rutgers UH Vascular Center
Newark, New Jersey, 07103
United States
Maimonides Medical Center
Brooklyn, New York, 11219
United States
St. Francis Hospital and Heart Center
Roslyn, New York, 11576
United States
SUNY Upstate Medical University
Syracuse, New York, 13120
United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
United States
The Ohio State University Medical Center
Columbus, Ohio, 43210
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
United States
UT Dell Medical School- Ascension
Austin, Texas, 78712
United States
Baylor Scott & White Research Institution
Dallas, Texas, 75226
United States
The University of Texas Health Houston
Houston, Texas, 77030
United States
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75204
United States
University of Utah
Salt Lake City, Utah, 84112
United States
University of Washington
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-14
Study Completion Date2030-06-30

Study Record Updates

Study Start Date2024-04-14
Study Completion Date2030-06-30

Terms related to this study

Keywords Provided by Researchers

  • TEVAR

Additional Relevant MeSH Terms

  • Type B Aortic Dissection