Status:
RECRUITING
IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
Lead Sponsor:
Duke University
Collaborating Sponsors:
The University of Texas Health Science Center, Houston
State University of New York - Downstate Medical Center
Conditions:
Type B Aortic Dissection
Eligibility:
All Genders
21+ years
Phase:
NA
Brief 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 com...
Detailed Description
The study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of an initial strategy for the treatment of uncomplicated type B aortic dissection (uTBAD). Patie...
Eligibility Criteria
Inclusion
- 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
- 4\. Ability to provide written informed consent 5. 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
- Known patient history of genetic aortopathy
- Penetrating Aortic Ulcer without concomitant uTBAD
- Intramural hematoma without concomitant uTBAD
- Iatrogenic (traumatic) aortic dissection
Key Trial Info
Start Date :
April 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2030
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT06087029
Start Date
April 14 2024
End Date
June 30 2030
Last Update
September 25 2025
Active Locations (60)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Honorhealth
Phoenix, Arizona, United States, 85020
3
Memorial Care Long Beach Medical Center
Long Beach, California, United States, 90806
4
Keck Medical Center of USC
Los Angeles, California, United States, 90033