IMPRoving Outcomes in Vascular DisEase- Aortic Dissection
Status: Recruiting
Location: See all (62) locations...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:
• Age \> 21 years
• Patients with a Stanford type B aortic dissection not involving the aorta at or proximal to the innominate artery, without rupture and/or malperfusion syndrome (renal, mesenteric, or extremity) who are within 48 hours to 6 weeks after start of index admission for their type B dissection
• Ability to provide written informed consent
• Investigator believes anatomy is suitable for TEVAR
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
Honorhealth
RECRUITING
Phoenix
California
Memorial Care Long Beach Medical Center
RECRUITING
Long Beach
Keck Medical Center of USC
RECRUITING
Los Angeles
University of California San Diego
WITHDRAWN
San Diego
University of California
RECRUITING
San Francisco
Stanford University Medical Center
WITHDRAWN
Stanford
Colorado
University of Colorado Denver
RECRUITING
Aurora
Memorial Hospital Central
RECRUITING
Colorado Springs
Connecticut
Hartford Hospital
RECRUITING
Hartford
Yale University
RECRUITING
New Haven
Florida
University of Florida Health
RECRUITING
Gainesville
Tampa General Hospital
RECRUITING
Tampa
Illinois
Northwestern University
RECRUITING
Chicago
The University of Chicago
WITHDRAWN
Chicago
Southern Illinois University School of Medicine
RECRUITING
Springfield
Indiana
Indiana University Methodist Hospital
RECRUITING
Indianapolis
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
University of Massachusetts Memorial
RECRUITING
Worcester
Maryland
Johns Hopkins University
RECRUITING
Baltimore
Maine
MaineHealth
RECRUITING
Scarborough
Michigan
University of Michigan Health
RECRUITING
Ann Arbor
Henry Ford Health System
RECRUITING
Detroit
Spectrum Health and Hospitals and Corewell
RECRUITING
Grand Rapids
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Mayo Clinic
WITHDRAWN
Rochester
Missouri
University of Missouri Health Care
RECRUITING
Columbia
Washington University School of Medicine
WITHDRAWN
St Louis
North Carolina
University of North Carolina Chapel Hill
WITHDRAWN
Chapel Hill
Sanger Heart & Vascular Institute
WITHDRAWN
Charlotte
Duke University Medical Center
RECRUITING
Durham
Nebraska
University of Nebraska Medical Center
WITHDRAWN
Omaha
New Jersey
Cooper University Hospital
RECRUITING
Camden
Rutgers UH Vascular Center
RECRUITING
Jersey City
New York
Maimonides Medical Center
WITHDRAWN
Brooklyn
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
University of Rochester Medical Center
RECRUITING
Rochester
St. Francis Hospital and Heart Center
RECRUITING
Roslyn
Stony Brook University Medical Center
RECRUITING
Stony Brook
SUNY Upstate Medical University
RECRUITING
Syracuse
Ohio
Harrington Heart and Vascular Institute
RECRUITING
Cleveland
The Ohio State University Medical Center
RECRUITING
Columbus
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Texas
UT Dell Medical School- Ascension
RECRUITING
Austin
Baylor Scott & White Research Institute
RECRUITING
Dallas
UT Southwestern Medical Center
RECRUITING
Dallas
Houston Methodist Hospital
RECRUITING
Houston
The University of Texas Health Houston
RECRUITING
Houston
Baylor Scott & White The Heart Hospital - Plano
RECRUITING
Plano
Utah
University of Utah
RECRUITING
Salt Lake City
Virginia
Sentara Cardiovascular Research Institute
RECRUITING
Norfolk
Washington
University of Washington
RECRUITING
Seattle
Wisconsin
University of Wisconsin
RECRUITING
Madison
Medical College of Wisconsin
RECRUITING
Milwaukee
West Virginia
CAMC Clinical Trials Center
RECRUITING
Charleston
Other Locations
Canada
CHUM - Centre hospitalier de l'Universite de Montreal
RECRUITING
Montreal
McGill University Medical Center
RECRUITING
Montreal
Contact Information
Primary
Megan Roebuck, M.S.
megan.roebuck@duke.edu
919-316-0628
Backup
Kady-Ann Steen-Burrell, Ph.D.
kady.ann.steen.burrell@duke.edu
919-530-9711
Time Frame
Start Date: 2024-04-14
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 1100
Treatments
Experimental: Upfront TEVAR plus Medical Therapy
Participants randomized to upfront TEVAR will receive a commercially available device customized to their individual anatomical requirements. Stent-graft implantation will be performed either in the operating room with appropriate digital imaging equipment to allow fluoroscopic and trans-esophageal echo (TEE) guidance or the catheterization laboratory, angiographic suite (with digital angiographic equipment).
Active_comparator: Medical Therapy with surveillance for deterioration
Participants randomized to upfront Medical Therapy with Surveillance for Deterioration will be treated per routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.
Related Therapeutic Areas
Sponsors
Collaborators: The University of Texas Health Science Center, Houston, State University of New York - Downstate Medical Center, Oregon Health and Science University, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Duke University