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RECRUITING Not applicable ClinicalTrials.gov

IMPRoving Outcomes in Vascular DisEase - Aortic Dissection

Sponsor: Duke University • ClinicalTrials.gov ID: NCT06087029

Registry updated: 2026-10-14
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Description

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.

Interventions

  • TEVAR (Procedure)
    Thoracic endovascular aortic repair
  • Guideline directed medical therapy and surveillance of dissection (Other)
    Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.

Eligibility criteria

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

Conditions

Type B Aortic Dissection

Locations

  • University of Alabama at Birmingham — Birmingham, Alabama, United States
  • Honorhealth — Phoenix, Arizona, United States
  • University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
  • Memorial Care Long Beach Medical Center — Long Beach, California, United States
  • Keck Medical Center of USC — Los Angeles, California, United States
  • Kaiser Permanente San Francisco — Pleasanton, 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 — Jersey City, New Jersey, United States
  • Maimonides Medical Center — Brooklyn, New York, United States
  • NYU Langone Health — New York, 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
  • Providence Heart and Vascular Institute — Portland, Oregon, 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 Institute — Dallas, Texas, United States
  • UT Southwestern Medical Center — 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
  • CHUM - Centre hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada
  • McGill University Medical Center — Montreal, Quebec, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record