IMPRoving Outcomes in Vascular DisEase - Aortic Dissection

Study Status: Recruiting

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.

  • Sex: ALL
  • Minimum Age: 21 Years

Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:

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

4. Ability to provide written informed consent 5. Investigator believes anatomy is suitable for TEVAR

Exlusion 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

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Type B Aortic Dissection

Intervention/Treatment

Intervention/Treatment

  • PROCEDURE : TEVAR
  • OTHER : Guideline directed medical therapy and surveillance of dissection

Sponsor

Duke University

Principal Investigator(s)

  • Manesh R Patel, M.D., PRINCIPAL_INVESTIGATOR, Duke University
  • Firas F Mussa, M.D., PRINCIPAL_INVESTIGATOR, The University of Texas at Houston
  • Panos Kougias, M.D., PRINCIPAL_INVESTIGATOR, The State University of New York at Downstate
  • Sreekanth Vemulapalli, M.D., PRINCIPAL_INVESTIGATOR, Duke University
  • Sean O'Brien, Ph.D., PRINCIPAL_INVESTIGATOR, Duke University

Phase

  • NA