IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
Start Date
4/14/2024
Completion Date
6/30/2030
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.
Detailed Description
The study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of an initial strategy for the treatment of uncomplicated type B aortic dissection (uTBAD). Patients with uTBAD and no prior history of aortic intervention will be randomized within 48 hours to 6 weeks after index admission to one of the two initial strategies. Follow-up will be ascertained via a centralized call center and ascertainment of medical records, as well as remote blood pressure monitoring. Recommendations regarding medical therapy will be made to enrolling centers and feedback on the quality of medical care given, however, all subsequent care, with the exception of aortic interventions, will be at the discretion of the responsible clinical care team. Aortic interventions will allowable only as per protocol.
Eligibility Criteria
Age Range: 21 years to No maximum
Interventions
TEVAR
Guideline directed medical therapy and surveillance of dissection
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
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 California San Diego
San Diego, California 92110
United States
University of California
San Francisco, California 94143
United States
Stanford University Medical Center
Stanford, California 94305
United States
University of Colorado Denver
Aurora, Colorado 80045
United States
Memorial Hospital Central
Colorado Springs, Colorado 90803
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
The University of Chicago
Chicago, Illinois 60637
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
Johns Hopkins University
Baltimore, Maryland 21230
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
University of Massachusetts Memorial
Worcester, Massachusetts 01655
United States
University of Michigan Health
Ann Arbor, Michigan 48109
United States
Henry Ford Health System
Detroit, Michigan 48202
United States
Spectrum Health and Hospitals and Corewell
Grand Rapids, Michigan 49503
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
University of Missouri Health Care
Columbia, Missouri 65212
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Cooper University Hospital
Camden, New Jersey 08103
United States
Rutgers UH Vascular Center
Jersey City, New Jersey 07302
United States
Maimonides Medical Center
Brooklyn, New York 11219
United States
NYU Langone Health
New York, New York 10016
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
University of Rochester Medical Center
Rochester, New York 14642
United States
St. Francis Hospital and Heart Center
Roslyn, New York 11576
United States
Stony Brook University Medical Center
Stony Brook, New York 11794
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
Sanger Heart & Vascular Institute
Charlotte, North Carolina 28201
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Harrington Heart and Vascular Institute
Cleveland, Ohio 44106
United States
The Ohio State University Medical Center
Columbus, Ohio 43210
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
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 Institute
Dallas, Texas 75226
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
The University of Texas Health Houston
Houston, Texas 77030
United States
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas 75093
United States
University of Utah
Salt Lake City, Utah 84112
United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia 23507
United States
University of Washington
Seattle, Washington 98104
United States
CAMC Clinical Trials Center
Charleston, West Virginia 25304
United States
University of Wisconsin
Madison, Wisconsin 53792
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
CHUM - Centre hospitalier de l'Universite de Montreal
Montreal, Quebec H2X 0C1
Canada
McGill University Medical Center
Montreal, Quebec H3A 0G4
Canada