Summary

Eligibility
for people ages 21 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around

Description

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.

Details

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.

Keywords

Type B Aortic Dissection, TEVAR, Vascular Diseases, Aortic Dissection, Guideline directed medical therapy and surveillance of dissection

Eligibility

You can join if…

Open to people ages 21 years and up

  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

You CAN'T join if...

  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

Locations

  • University of California San Diego accepting new patients
    San Diego California 92110 United States
  • Memorial Hospital Central accepting new patients
    Colorado Springs Colorado 90803 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Duke University
ID
NCT06087029
Study Type
Interventional
Participants
Expecting 1100 study participants
Last Updated