IMPRoving Outcomes In Vascular DisEase- Aortic Dissection
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-012623
NCT ID: NCT06087029
About this study
The purpose of this study 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 12/5/23. Questions regarding updates should be directed to the study team contact
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available