IMPRoving Outcomes in Vascular DisEase - Aortic Dissection

Purpose

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.

Condition

  • Type B Aortic Dissection

Eligibility

Eligible Ages
Over 21 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age > 21 years 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

  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 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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).
  • Procedure: TEVAR
    Thoracic endovascular aortic repair
  • Other: 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.
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.
  • Other: 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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35294
Contact:
Adam Beck, MD

Honorhealth
Phoenix 5308655, Arizona 5551752 85020
Contact:
Hasan Aldailami, MD

Memorial Care Long Beach Medical Center
Long Beach 5367929, California 5332921 90806
Contact:
Ali Khoynezhad

Keck Medical Center of USC
Los Angeles 5368361, California 5332921 90033
Contact:
Gregory Magee, MD

University of California
San Francisco 5391959, California 5332921 94143
Contact:
Jade Hiramoto, MD

University of Colorado Denver
Aurora 5412347, Colorado 5417618 80045
Contact:
Brett Reece, MD

Memorial Hospital Central
Colorado Springs 5417598, Colorado 5417618 90803
Contact:
Mel Sharafuddin, MD

Hartford Hospital
Hartford 4835797, Connecticut 4831725 06102
Contact:
Mohiuddin Cheema, MD

Yale University
New Haven 4839366, Connecticut 4831725 06510
Contact:
David Kuwayama, MD

University of Florida Health
Gainesville 4156404, Florida 4155751 32608
Contact:
Michol Cooper, MD

Tampa General Hospital
Tampa 4174757, Florida 4155751 33606
Contact:
Dean Arnaoutakis, MD

Northwestern University
Chicago 4887398, Illinois 4896861 60611
Contact:
Mark Eskandari, MD

Southern Illinois University School of Medicine
Springfield 4250542, Illinois 4896861 62702
Contact:
Laura Healy, MD

Indiana University Methodist Hospital
Indianapolis 4259418, Indiana 4921868 46202
Contact:
Raghu Motaganahalli, MD

University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
Contact:
William Poulson, MD

MaineHealth
Scarborough 4977882, Maine 4971068 04101
Contact:
Kristina Giles, MD

Johns Hopkins University
Baltimore 4347778, Maryland 4361885 21230
Contact:
Caitlin Hicks, MD

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Matthew Eagleton, MD

Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
Contact:
Matthew T Menard, MD

University of Massachusetts Memorial
Worcester 4956184, Massachusetts 6254926 01655
Contact:
Andres Schanzer, MD

University of Michigan Health
Ann Arbor 4984247, Michigan 5001836 48109
Contact:
Bo Yang, MD

Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202
Contact:
Loay Kabbani, MD

Spectrum Health and Hospitals and Corewell
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Eanas Yassa, MD

University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455
Contact:
Nolan Cirillo-Penn, MD

University of Missouri Health Care
Columbia 4381982, Missouri 4398678 65212
Contact:
Jonathan Bath, MD

Cooper University Hospital
Camden 4501018, New Jersey 5101760 08103
Contact:
Philip Batista, MD

Rutgers UH Vascular Center
Newark 5101798, New Jersey 5101760 07103
Contact:
Karim Salem, MD

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
Contact:
Rami Tadros, MD

University of Rochester Medical Center
Rochester 5134086, New York 5128638 14642
Contact:
Doran Mix, MD

St. Francis Hospital and Heart Center
Roslyn 5134415, New York 5128638 11576
Contact:
Timothy Carter, MD

Stony Brook University Medical Center
Stony Brook 5139865, New York 5128638 11794
Contact:
Apostolos Tassiopoulos, MD

SUNY Upstate Medical University
Syracuse 5140405, New York 5128638 13120
Contact:
Palma Shaw, MD

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710
Contact:
G. Chad Hughes, MD

Harrington Heart and Vascular Institute
Cleveland 5150529, Ohio 5165418 44106
Contact:
Jae S Cho, MD

The Ohio State University Medical Center
Columbus 4509177, Ohio 5165418 43210
Contact:
Xiaoyi Teng, MD

Oregon Health & Science University
Portland 5746545, Oregon 5744337 97239
Contact:
Sherene Shalhub, MD

University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Nimesh Desai, MD

Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Babak Abai, MD

University of Pittsburgh Medical Center
Pittsburgh 5206379, Pennsylvania 6254927 15213
Contact:
Ibrahim Sultan, MD

UT Dell Medical School- Ascension
Austin 4671654, Texas 4736286 78712
Contact:
George Arnaoutakis, MD

Baylor Scott & White Research Institution
Dallas 4684888, Texas 4736286 75226
Contact:
John Eidt, MD

UT Southwestern- Dallas
Dallas 4684888, Texas 4736286 75390
Contact:
Michael Shih, MD

Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030
Contact:
Marvin Atkins, MD

The University of Texas Health Houston
Houston 4699066, Texas 4736286 77030
Contact:
Firas Mussa, MD

Baylor Scott & White The Heart Hospital - Plano
Plano 4719457, Texas 4736286 75204
Contact:
Dennis Gable, MD

University of Utah
Salt Lake City 5780993, Utah 5549030 84112
Contact:
Nathan Droz, MD

Sentara Cardiovascular Research Institute
Norfolk 4776222, Virginia 6254928 23507
Contact:
David Dexter, MD

University of Washington
Seattle 5809844, Washington 5815135 98104
Contact:
Benjamin Starnes, MD

CAMC Clinical Trials Center
Charleston 4801859, West Virginia 4826850 25304
Contact:
Shadi Abu-halimah, MD

University of Wisconsin
Madison 5261457, Wisconsin 5279468 53792
Contact:
John Rectenwald, MD

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
Joe Hart, MD

More Details

NCT ID
NCT06087029
Status
Recruiting
Sponsor
Duke University

Study Contact

Megan Roebuck, M.S.
919-316-0628
megan.roebuck@duke.edu

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.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center