IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
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 patien
| Condition(s) | Type B Aortic Dissection |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 3. Ability to provide written informed consent 4. 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 |
| Ages | 21 Years |
| Sex | All |
| Lead sponsor | Duke University |
| Locations | Birmingham, Alabama, United States; Phoenix, Arizona, United States; Long Beach, California, United States; Los Angeles, California, United States; San Diego, California, United States; San Francisco, California, United States (+57 more sites) |
| Start date | 2024-04-14 |
| NCT ID | NCT06087029 |
| Official listing | https://clinicaltrials.gov/study/NCT06087029 |