Recruiting

Observational StudyIMPRoving Outcomes in Vascular DisEase - Aortic Dissection

Sponsor:

Duke University

Code:

NCT06087029

Conditions

Type B Aortic Dissection

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

TEVAR

Guideline directed medical therapy and surveillance of dissection

Study Details

Brief 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.

Conditions

Type B Aortic Dissection

Study ID

NCT06087029

Start date

Apr 14, 2024

Status verified date

Feb, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 1, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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
3. Ability to provide written informed consent
4. 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

Enrollment

1100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

All-cause death or major aortic complications (MAC) [ Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years ]

Central Contacts and Locations

Central contacts

Megan Roebuck, M.S.

919-316-0628 megan.roebuck@duke.edu

Kady-Ann Steen-Burrell, Ph.D.

919-530-9711 kady.ann.steen.burrell@duke.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator:

Adam Beck, MD

Honorhealth

Recruiting

Phoenix, Arizona, United States, 85020

Contacts

General Office Number

480-323-1046

Principal Investigator:

Hasan Aldailami, MD

Memorial Care Long Beach Medical Center

Recruiting

Long Beach, California, United States, 90806

Principal Investigator:

Rodney White, MD

Keck Medical Center of USC

Recruiting

Los Angeles, California, United States, 90033

Principal Investigator:

Alyssa Pyun, MD

University of California

Recruiting

San Francisco, California, United States, 94143

Contacts

Alexis Callanta

415-353-4368

Principal Investigator:

Jade Hiramoto, MD

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Principal Investigator:

Brett Reece

Memorial Hospital Central

Recruiting

Colorado Springs, Colorado, United States, 90803

Principal Investigator:

Mel Sharafuddin, MD

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Marianne McCarthy

860-972-1788

Principal Investigator:

Mohiuddin Cheema, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Principal Investigator:

David Kuwayama, MD

University of Florida Health

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Nancy Hanson

352-273-7598

Principal Investigator:

Michol Cooper, MD

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Eric Johnson

813-844-4686

Principal Investigator:

Halim Yammine, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Andrea Silverman

312-926-4000

Principal Investigator:

Mark Eskandari, MD

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Rebecca Owens

217-545-7321

Principal Investigator:

Laura Healy, MD

Indiana University Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Raghu Motaganahalli, MD

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Principal Investigator:

William Poulson, MD

MaineHealth

Recruiting

Scarborough, Maine, United States, 04101

Contacts

Monica Palmeri

207-662-2090

Principal Investigator:

Kristina Giles, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21230

Principal Investigator:

Caitlin Hicks, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Research Office

617-726-8875

Principal Investigator:

Matthew Eagleton, MD

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

BWH Vascular Surgery Research

617-525-8555

Principal Investigator:

Matthew T Menard, MD

University of Massachusetts Memorial

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Shauneen Valliere

508-856-1767

Principal Investigator:

Andres Schanzer, MD

University of Michigan Health

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Bo Yang, MD

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Research Office

313-916-8006

Principal Investigator:

Loay Kabbani, MD

Spectrum Health and Hospitals and Corewell

Recruiting

Grand Rapids, Michigan, United States, 49503

Principal Investigator:

Eanas Yassa, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Surgery Clinical Trials Office

612-624-7463

Principal Investigator:

Nolan Cirillo-Penn, MD

University of Missouri Health Care

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Brianna Ledbetter

573-884-7569

Principal Investigator:

Jonathan Bath, MD

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Jonelle O'Shea

856-342-2150

Principal Investigator:

Philip Batista, MD

Rutgers UH Vascular Center

Recruiting

Jersey City, New Jersey, United States, 07302

Principal Investigator:

Karim Salem, MD

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Gregory Magee, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Bridget Coyle

212-241-4461

Principal Investigator:

Rami Tadros, MD

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Mary Bourret

585-276-1738

Principal Investigator:

Doran Mix, MD

St. Francis Hospital and Heart Center

Recruiting

Roslyn, New York, United States, 11576

Principal Investigator:

Timothy Carter, MD

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Principal Investigator:

Apostolos Tassiopoulos, MD

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13120

Contacts

Maria Walker

315-464-8272

Principal Investigator:

Palma Shaw, MD

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

G. Chad Hughes, MD

Harrington Heart and Vascular Institute

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Amy Kluge

216-844-2988

Principal Investigator:

Jae S Cho, MD

The Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Xiaoyi Teng, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Amie Lorisch

971-349-6659

Principal Investigator:

Sherene Shalhub, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Nimesh Desai, MD

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Principal Investigator:

Babak Abai, MD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Erin Cochran

412-647-8467

Principal Investigator:

Derek Serna-Gallegos, MD

UT Dell Medical School- Ascension

Recruiting

Austin, Texas, United States, 78712

Contacts

Madeline Gleason

512-324-3434

Principal Investigator:

George Arnaoutakis, MD

Baylor Scott & White Research Institute

Recruiting

Dallas, Texas, United States, 75226

Principal Investigator:

John Eidt, MD

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Emma Bryant

214-648-6743

Principal Investigator:

Michael Shih, MD

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Solange Basagoitia

832-301-1168

Saba Khan

832-301-1168

Principal Investigator:

Marvin Atkins, MD

The University of Texas Health Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Mariano Montemayor

713-486-5194

Principal Investigator:

Naveed Saqib, MD

Baylor Scott & White The Heart Hospital - Plano

Recruiting

Plano, Texas, United States, 75093

Principal Investigator:

Dennis Gable, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Julie Hales

801-587-1450

Principal Investigator:

Nathan Droz, MD

Sentara Cardiovascular Research Institute

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Kara Wiggins

757-388-7511

Principal Investigator:

David Dexter, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98104

Principal Investigator:

Benjamin Starnes, MD

CAMC Clinical Trials Center

Recruiting

Charleston, West Virginia, United States, 25304

Contacts

Kristi Sutphin

304-388-9944

Principal Investigator:

Shadi Abu-halimah, MD

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Principal Investigator:

John Rectenwald, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Beth Weseman

414-955-1810

Principal Investigator:

Joe Hart, MD

CHUM - Centre hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Contacts

Benjamin Orcese

514-890-8000

Principal Investigator:

Laura Drudi, MD

McGill University Medical Center

Recruiting

Montreal, Quebec, Canada, H3A 0G4

Contacts

Hila Tabrizian

514-718-5025

Principal Investigator:

Robert James Doonan, MD

More Information

Sponsor

Duke University

Last update posted

Apr 29, 2026

Last verified

Feb, 2026

Keywords

TEVAR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Duke University on 2026-04-29.