For Providers

Study Background

Aortic dissection is the most common fatal event involving the aorta, resulting in approximately 12,000 deaths annually in the United States. IMPROVE-AD is a multicenter, pragmatic, randomized trial comparing the use of upfront TEVAR (thoracic endovascular aortic repair) alongside medical therapy versus upfront medical therapy alongside regular follow-up for patients with uncomplicated type B aortic dissection. Currently, there is not enough evidence on the impact of upfront TEVAR for this condition.

Additionally, the existing research data on treatments for type B aortic dissection do not provide enough information that is applicable to women or the diverse set of racial and ethnic minority groups in the United States. IMPROVE-AD aims to ensure the study population is representative of the population with type B aortic dissection.

The pragmatic design of the study is important to IMPROVE-AD because it:

  • Maintains broad eligibility criteria, which allows for easier patient recruitment and retention and ensures the trial population is representative of the population with type B aortic dissection.
  • Specifies medical therapy plus follow-up as the comparison group, which allows flexibility for changes in care and prevents the results of the study from being obsolete when the trial is completed.
  • Is a hybrid-virtual, decentralized design that minimizes burden on site staff by allowing sites to focus their effort on screening, enrollment, and clinical care, while performing the study-specific follow-up through a central call center.

IMPROVE-AD aims to enroll 1,100 participants to understand how best to treat type B aortic dissection. The following organizations supported conducting a trial to an answer this clinical question:

What else does IMPROVE-AD hope to learn?

IMPROVE-AD will conduct additional assessments and ancillary studies to inform the use of upfront TEVAR and treatment of type B aortic dissection:

  • Quality of Life Assessments: Short assessments of health-related quality of life are meant to capture any health benefits associated with the upfront TEVAR plus medical therapy strategy.
  • Economic and Resource Utilization Assessments: Detailed information on the quantity and cost of health care services received by participants in both treatment groups will be collected through a combination of assessment and connection to health care economic databases as part of this trial.
  • Imaging Substudy: All participants in both treatment groups who receive a computed tomographic angiogram (CTA), magnetic resonance angiogram (MRA), or invasive angiogram as part of routine care will have images uploaded electronically to create an image repository. The images could provide information on the natural history of the condition and help identify radiologic characteristics related to later complications.
  • Biorepository Substudy: For all participants in both treatment groups who give consent to participate in the biorepository substudy, saliva and/or blood samples will be collected at the time of enrollment for genetic and biomarker analysis.

If you have questions about IMPROVE-AD, please email IMPROVE-AD@dm.duke.edu.

 

for_providers