Cardiac Surgery - IMPROVE-AD
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.
Criteria:
Inclusion:
- Age > 21 years
- 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)
- Acuity: within 48 hours - 6 weeks of index admission
- Ability to provide written informed consent and comply with the protocol
- Investigator believes anatomy is suitable for TEVAR
Exclusion:
- 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 including serial imaging follow-up
- Known patient history of genetic aortopathy
- Penetrating Aortic Ulcer and Intramural hematoma
- Iatrogenic (traumatic) aortic dissection
- Previous aortic dissection or aortic surgery
- Prior aortic aneurysmal disease
Location(s): Hartford Hospital
ClinicalTrials.gov Link: https://clinicaltrials.gov/study/NCT06087029
Sponsor: Duke University
Contact: Marianne McCarthy 860-972-1788 marianne.mccarthy@hhchealth.org