IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
NCT ID: NCT06087029
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1100 participants
INTERVENTIONAL
2024-04-14
2030-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
TEVAR
Thoracic endovascular aortic repair
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.
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.
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.
Interventions
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TEVAR
Thoracic endovascular aortic repair
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.
Eligibility Criteria
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Inclusion Criteria
2. 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
4\. Ability to provide written informed consent 5. Investigator believes anatomy is suitable for TEVAR
Exclusion Criteria
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
5. Known patient history of genetic aortopathy
6. Penetrating Aortic Ulcer without concomitant uTBAD
7. Intramural hematoma without concomitant uTBAD
8. Iatrogenic (traumatic) aortic dissection
21 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
State University of New York - Downstate Medical Center
OTHER
Oregon Health and Science University
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Manesh R Patel, M.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Firas F Mussa, M.D.
Role: PRINCIPAL_INVESTIGATOR
The University of Texas at Houston
Panos Kougias, M.D.
Role: PRINCIPAL_INVESTIGATOR
The State University of New York at Downstate
Sreekanth Vemulapalli, M.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Sean O'Brien, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Honorhealth
Phoenix, Arizona, United States
Memorial Care Long Beach Medical Center
Long Beach, California, United States
Keck Medical Center of USC
Los Angeles, California, United States
University of California San Diego
San Diego, California, United States
University of California
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Memorial Hospital Central
Colorado Springs, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
University of Florida Health
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Indiana University Methodist Hospital
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
MaineHealth
Scarborough, Maine, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Massachusetts Memorial
Worcester, Massachusetts, United States
University of Michigan Health
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Spectrum Health and Hospitals and Corewell
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Missouri Health Care
Columbia, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Cooper University Hospital
Camden, New Jersey, United States
Rutgers UH Vascular Center
Newark, New Jersey, United States
Maimonides Medical Center
Brooklyn, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
St. Francis Hospital and Heart Center
Roslyn, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Sanger Heart & Vascular Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Harrington Heart and Vascular Institute
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
UT Dell Medical School- Ascension
Austin, Texas, United States
Baylor Scott & White Research Institution
Dallas, Texas, United States
UT Southwestern- Dallas
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
The University of Texas Health Houston
Houston, Texas, United States
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
University of Washington
Seattle, Washington, United States
CAMC Clinical Trials Center
Charleston, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Adam Beck, MD
Role: primary
Hasan Aldailami, MD
Role: primary
Ali Khoynezhad
Role: primary
Gregory Magee, MD
Role: primary
Jade Hiramoto, MD
Role: primary
Brett Reece, MD
Role: primary
Mel Sharafuddin, MD
Role: primary
Mohiuddin Cheema, MD
Role: primary
David Kuwayama, MD
Role: primary
Michol Cooper, MD
Role: primary
Dean Arnaoutakis, MD
Role: primary
Mark Eskandari, MD
Role: primary
Laura Healy, MD
Role: primary
Raghu Motaganahalli, MD
Role: primary
William Poulson, MD
Role: primary
Kristina Giles, MD
Role: primary
Caitlin Hicks, MD
Role: primary
Matthew Eagleton, MD
Role: primary
Matthew T Menard, MD
Role: primary
Andres Schanzer, MD
Role: primary
Bo Yang, MD
Role: primary
Loay Kabbani, MD
Role: primary
Eanas Yassa, MD
Role: primary
Nolan Cirillo-Penn, MD
Role: primary
Jonathan Bath, MD
Role: primary
Philip Batista, MD
Role: primary
Karim Salem, MD
Role: primary
Rami Tadros, MD
Role: primary
Doran Mix, MD
Role: primary
Timothy Carter, MD
Role: primary
Apostolos Tassiopoulos, MD
Role: primary
Palma Shaw, MD
Role: primary
G. Chad Hughes, MD
Role: primary
Jae S Cho, MD
Role: primary
Xiaoyi Teng, MD
Role: primary
Sherene Shalhub, MD
Role: primary
Nimesh Desai, MD
Role: primary
Babak Abai, MD
Role: primary
Ibrahim Sultan, MD
Role: primary
George Arnaoutakis, MD
Role: primary
John Eidt, MD
Role: primary
Michael Shih, MD
Role: primary
Marvin Atkins, MD
Role: primary
Firas Mussa, MD
Role: primary
Dennis Gable, MD
Role: primary
Nathan Droz, MD
Role: primary
David Dexter, MD
Role: primary
Benjamin Starnes, MD
Role: primary
Shadi Abu-halimah, MD
Role: primary
John Rectenwald, MD
Role: primary
Joe Hart, MD
Role: primary
Other Identifiers
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