IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

R
Raghu Motaganahalli, MD

Primary Investigator

Enrolling By Invitation
21 years - 100 years
All
Phase N/A
12 participants needed
1 Location

Brief description of study

Why is this study being done?
The study will be a prospective, pragmatic, randomized clinical trial ofhe comparative effectiveness of an initial strategy for the treatment of uncomplicated type B aortic dissection (uTBAD). 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.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

What will happen during the study?
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.
 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Type B Aortic Dissection
  • Age: 21 years - 100 years
  • Gender: All

Inclusion Criteria:

  1. Age > 21 years
  2. Stanford type B aortic dissection not involving the aorta at or proximal to the innominate artery, without rupture and/or malperfusion (renal, mesenteric, or extremity)
  3. Acuity: within 48 hours - 6 weeks of index admission
  4. Ability to provide written informed consent and comply with the protocol
  5. 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 including serial imaging follow-up
  5. Known patient history of genetic aortopathy
  6. Penetrating Aortic Ulcer and Intramural hematoma
  7. Iatrogenic (traumatic) aortic dissection
  8. Prior surgery for aortic dissection

Updated on 21 Apr 2025. Study ID: SURG-NHLBI-IMPROVE, 21438
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