IMPRoving Outcomes in Vascular DisEase- Aortic Dissection
- Conditions
- Type B Aortic Dissection
- Registration Number
- NCT06087029
- Lead Sponsor
- Duke University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Age > 21 years<br><br> 2. Stanford type B aortic dissection not involving the aorta at or proximal to the<br> innominate artery, without rupture and/or malperfusion (renal, mesenteric, or<br> extremity)<br><br> 3. Acuity: within 48 hours - 6 weeks of index admission<br><br> 4. Ability to provide written informed consent and comply with the protocol<br><br> 5. Investigator believes anatomy is suitable for TEVAR<br><br>Exclusion Criteria:<br><br> 1. Ongoing systemic infection<br><br> 2. Pregnant or planning to become pregnant in the next 3 months<br><br> 3. Life expectancy related to non-aortic conditions < 2 years<br><br> 4. Unwilling or unable to comply with all study procedures including serial imaging<br> follow-up<br><br> 5. Known patient history of genetic aortopathy<br><br> 6. Penetrating Aortic Ulcer and Intramural hematoma<br><br> 7. Iatrogenic (traumatic) aortic dissection<br><br> 8. Prior surgery for aortic dissection
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause death or major aortic complications (MAC)
- Secondary Outcome Measures
Name Time Method Quality of Life, as measured by the Abdominal Aortic Aneurysm Quality of Life questionnaire (AAAQol);Cumulative incidence of cardiovascular (CV) hospitalizations;Mean number of cardiovascular (CV) hospitalizations;Incidence of cardiovascular death;Incidence of all-cause mortality;Cumulative incidence of aortic-related hospitalizations;Mean number of aortic-related hospitalizations;Incidence of stroke;Incidence of paraplegia or paraparesis;Incidence of vascular access injury requiring surgical repair;Incidence of aortobronchial / aortoesophageal fistula;Incidence of retrograde type A dissection;Incidence of aortic-related death, including sudden cardiac deaths;Incidence of aortic-related death, excluding sudden cardiac deaths;Number of days alive and out of the hospital;Incidence of secondary percutaneous interventions after TEVAR