IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

Overview

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.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Randall DeMartino, M.D., M.S.

Contact us for the latest status

Contact information:

Jennifer Haen

(507) 284-5471

Haen.Jennifer@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20576155

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