IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

Launched by DUKE UNIVERSITY · Oct 11, 2023

Keywords

ClinConnect Summary

The IMPRoving Outcomes in Vascular DisEase trial is studying a treatment approach for patients with a type of condition called Type B aortic dissection, which is a tear in the aorta that doesn’t involve certain critical areas of the heart. The trial aims to find out if a more invasive treatment called TEVAR (a procedure that helps repair the aorta) combined with medical therapy is better at preventing serious complications or death compared to a more conservative method that relies on just medication and regular check-ups.

To participate in the trial, you must be at least 21 years old, diagnosed with Stanford type B aortic dissection without any ruptures, and be within 48 hours to 6 weeks of your initial hospital visit. The trial is currently looking for participants of all genders. If you join, you’ll be monitored closely, and your doctors will work with you to follow the study’s guidelines. It’s important to know that certain conditions, like ongoing infections or significant health issues unrelated to the aorta, may prevent you from joining the study. If you’re interested, talk to your doctor to see if this trial might be right for you.

Gender

ALL

Eligibility criteria

• 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