IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

ID#: NCT06087029

Age: 21 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: April 14, 2024

End Date: June 30, 2030

Contact Information:
Megan Roebuck, M.S.
919-316-0628
Jacqueline Huvane, Ph.D.
919-668-8282
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 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

5. Investigator believes anatomy is suitable for TEVAR

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. Prior surgery for aortic dissection
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