IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
IMPRoving Outcomes in Vascular DisEase- Aortic Dissection
Duke University
1,100 participants
Apr 14, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria8
- 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
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Interventions
Thoracic endovascular aortic repair
Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.
Locations(62)
View Full Details on ClinicalTrials.gov
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NCT06087029