IMPRoving Outcomes in Vascular DisEase- Aortic Dissection
Trial ID or NCT#
NCT06087029
Status
NOT RECRUITING
Purpose
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.
Official Title
IMPRoving Outcomes in Vascular DisEase- Aortic Dissection
Eligibility Criteria
Ages Eligible for Study: Older than 21 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Age > 21 years 2. 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) 3. Acuity: within 48 hours - 6 weeks of index admission 4. Ability to provide written informed consent and comply with the protocol
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 including serial imaging follow-up 5. Known patient history of genetic aortopathy 6. Penetrating Aortic Ulcer and Intramural hematoma 7. Iatrogenic (traumatic) aortic dissection 8. Previous aortic dissection or aortic surgery 9. Prior aortic aneurysmal disease
Investigator(s)
View on ClinicalTrials.gov
