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NCT06087029NARecruiting

IMPRoving Outcomes in Vascular DisEase - Aortic Dissection

Duke University

Start Date

4/14/2024

Completion Date

6/30/2030

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.

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.

Eligibility Criteria

Age Range: 21 years to No maximum

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

Interventions

PROCEDURE

TEVAR

OTHER

Guideline directed medical therapy and surveillance of dissection

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Conditions

Type B Aortic Dissection

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35294

United States

Honorhealth

Phoenix, Arizona 85020

United States

Memorial Care Long Beach Medical Center

Long Beach, California 90806

United States

Keck Medical Center of USC

Los Angeles, California 90033

United States

University of California San Diego

San Diego, California 92110

United States

University of California

San Francisco, California 94143

United States

Stanford University Medical Center

Stanford, California 94305

United States

University of Colorado Denver

Aurora, Colorado 80045

United States

Memorial Hospital Central

Colorado Springs, Colorado 90803

United States

Hartford Hospital

Hartford, Connecticut 06102

United States

Yale University

New Haven, Connecticut 06510

United States

University of Florida Health

Gainesville, Florida 32608

United States

Tampa General Hospital

Tampa, Florida 33606

United States

Northwestern University

Chicago, Illinois 60611

United States

The University of Chicago

Chicago, Illinois 60637

United States

Southern Illinois University School of Medicine

Springfield, Illinois 62702

United States

Indiana University Methodist Hospital

Indianapolis, Indiana 46202

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

MaineHealth

Scarborough, Maine 04101

United States

Johns Hopkins University

Baltimore, Maryland 21230

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

University of Massachusetts Memorial

Worcester, Massachusetts 01655

United States

University of Michigan Health

Ann Arbor, Michigan 48109

United States

Henry Ford Health System

Detroit, Michigan 48202

United States

Spectrum Health and Hospitals and Corewell

Grand Rapids, Michigan 49503

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

University of Missouri Health Care

Columbia, Missouri 65212

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

Cooper University Hospital

Camden, New Jersey 08103

United States

Rutgers UH Vascular Center

Jersey City, New Jersey 07302

United States

Maimonides Medical Center

Brooklyn, New York 11219

United States

NYU Langone Health

New York, New York 10016

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

University of Rochester Medical Center

Rochester, New York 14642

United States

St. Francis Hospital and Heart Center

Roslyn, New York 11576

United States

Stony Brook University Medical Center

Stony Brook, New York 11794

United States

SUNY Upstate Medical University

Syracuse, New York 13120

United States

University of North Carolina Chapel Hill

Chapel Hill, North Carolina 27599

United States

Sanger Heart & Vascular Institute

Charlotte, North Carolina 28201

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Harrington Heart and Vascular Institute

Cleveland, Ohio 44106

United States

The Ohio State University Medical Center

Columbus, Ohio 43210

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania 19107

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213

United States

UT Dell Medical School- Ascension

Austin, Texas 78712

United States

Baylor Scott & White Research Institute

Dallas, Texas 75226

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

The University of Texas Health Houston

Houston, Texas 77030

United States

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas 75093

United States

University of Utah

Salt Lake City, Utah 84112

United States

Sentara Cardiovascular Research Institute

Norfolk, Virginia 23507

United States

University of Washington

Seattle, Washington 98104

United States

CAMC Clinical Trials Center

Charleston, West Virginia 25304

United States

University of Wisconsin

Madison, Wisconsin 53792

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

CHUM - Centre hospitalier de l'Universite de Montreal

Montreal, Quebec H2X 0C1

Canada

McGill University Medical Center

Montreal, Quebec H3A 0G4

Canada