Print Send My Information

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

Eligibility

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

Inclusion Criteria

  1. Age > 21 years 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. Acuity: within 48 hours - 6 weeks of index admission 4. Ability to provide written informed consent and comply with the protocol 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 including serial imaging follow-up 5. Known patient history of genetic aortopathy 6. Penetrating Aortic Ulcer and Intramural hematoma 7. Iatrogenic (traumatic) aortic dissection 8. Prior surgery for 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, Alabama 35294
Contact:
Adam Beck, MD

Honorhealth
Phoenix, Arizona 85020
Contact:
Hasan Aldailami, MD

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

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

University of California San Diego
San Diego, California 92110
Contact:
Mahmoud Malas, MD

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

Stanford University Medical Center
Stanford, California 94305
Contact:
John MacArthur, MD

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

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

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

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

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

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

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

The University of Chicago
Chicago, Illinois 60637
Contact:
Trissa Babrowski, MD

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

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

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

MaineHealth
Scarborough, Maine 04101
Contact:
Kristina Giles, MD

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

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

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

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

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

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

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

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Randall DeMartino, MD

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

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Luis Sanchez, MD

University of Nebraska Medical Center
Omaha, Nebraska 68198
Contact:
Aleem Siddique, MD

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

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

Maimonides Medical Center
Brooklyn, New York 11219
Contact:
Robert Rhee, MD

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

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

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

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

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

University of North Carolina Chapel Hill
Chapel Hill, North Carolina 27599
Contact:
Mark Farber, MD

Sanger Heart & Vascular Institute
Charlotte, North Carolina 28201
Contact:
Frank Arko, MD

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Medical College of Wisconsin
Milwaukee, Wisconsin 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

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