IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
ConditionType B Aortic Dissection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorDuke University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- TEVAR
- Guideline directed medical therapy and surveillance of dissection
Treatment groups
1,100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Duke University
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborator
State University of New York - Downstate Medical Center
Collaborator
Oregon Health and Science University
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov