IMPRoving Outcomes in Vascular DisEase - Aortic Dissection

Recruiting now · Not applicable

Conditions studied: Type B Aortic Dissection

In brief

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.

Key facts

Study ID

NCT06087029

Run by

Duke University

People needed

1100

Starts

2024-04-14

Expected to finish

2030-06-30

Last updated by the study team

2026-04-29

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 21 years
• 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
• Ability to provide written informed consent
• Investigator believes anatomy is suitable for TEVAR

You may not qualify if…

• Ongoing systemic infection
• Pregnant or planning to become pregnant in the next 3 months
• Life expectancy related to non-aortic conditions < 2 years
• Unwilling or unable to comply with all study procedures
• Known patient history of genetic aortopathy
• Penetrating Aortic Ulcer without concomitant uTBAD
• Intramural hematoma without concomitant uTBAD
• Iatrogenic (traumatic) aortic dissection

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Keck Medical Center of USC — Los Angeles, California, United States (enrolling)
• Honorhealth — Phoenix, Arizona, United States (enrolling)
• University of California — San Francisco, California, United States (enrolling)
• Spectrum Health and Hospitals and Corewell — Grand Rapids, Michigan, United States (enrolling)
• University of Colorado Denver — Aurora, Colorado, United States (enrolling)
• Memorial Hospital Central — Colorado Springs, Colorado, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• University of Florida Health — Gainesville, Florida, United States (enrolling)
• Tampa General Hospital — Tampa, Florida, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Memorial Care Long Beach Medical Center — Long Beach, California, United States (enrolling)
• Southern Illinois University School of Medicine — Springfield, Illinois, United States (enrolling)
• Indiana University Methodist Hospital — Indianapolis, Indiana, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• MaineHealth — Scarborough, Maine, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• University of Massachusetts Memorial — Worcester, Massachusetts, United States (enrolling)
• University of Michigan Health — Ann Arbor, Michigan, United States (enrolling)
• Henry Ford Health System — Detroit, Michigan, United States (enrolling)
• University of Missouri Health Care — Columbia, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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