NCT06087029 IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
| NCT ID | NCT06087029 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Type B Aortic Dissection |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2024-04-14 |
| Primary Completion | 2030-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,100 participants in total. It began in 2024-04-14 with a primary completion date of 2030-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 concomitant uTBAD 8. Iatrogenic (traumatic) aortic dissection
Contact & Investigator
Manesh R Patel, M.D.
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT06087029 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Type B Aortic Dissection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06087029 currently recruiting?
Yes, NCT06087029 is actively recruiting participants. Contact the research team at megan.roebuck@duke.edu for enrollment information.
Where is the NCT06087029 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Long Beach, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT06087029 clinical trial?
NCT06087029 is sponsored by Duke University. The principal investigator is Manesh R Patel, M.D. at Duke University. The trial plans to enroll 1,100 participants.