NCT06087029

IMPRoving Outcomes in Vascular DisEase - Aortic Dissection

IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of an initial strategy for the treatment of uncomplicated type B aortic dissection (uTBAD). Patients with uTBAD and no prior history of aortic intervention will be randomized within 48 hours to 6 weeks after index admission to one of the two initial strategies. Follow-up will be ascertained via a centralized call center and ascertainment of medical records, as well as remote blood pressure monitoring. Recommendations regarding medical therapy will be made to enrolling centers and feedback on the quality of medical care given, however, all subsequent care, with the exception of aortic interventions, will be at the discretion of the responsible clinical care team. Aortic interventions will allowable only as per protocol.

Conditions

• Type B Aortic Dissection

Interventions

Type	Name	Description
PROCEDURE	TEVAR	Thoracic endovascular aortic repair
OTHER	Guideline directed medical therapy and surveillance of dissection	Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.

Timeline

• Start date: 2024-04-14
• Primary completion: 2030-06-01
• Completion: 2030-06-30
• First posted: 2023-10-17
• Last updated: 2026-02-20

Locations

62 sites across 2 countries: United States, Canada