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
Kady-Ann Steen-Burrell, Ph.D.
919-530-9711
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. 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 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

5. Known patient history of genetic aortopathy

6. Penetrating Aortic Ulcer without concomitant uTBAD

7. Intramural hematoma without concomitant uTBAD

8. Iatrogenic (traumatic) aortic dissection
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