IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
ConditionType B Aortic Dissection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 21 years
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
Ability to provide written informed consent
Investigator believes anatomy is suitable for TEVAR
Disqualifiers
Ongoing systemic infection
Pregnant or planning to become pregnant in the next 3 months
Life expectancy related to non-aortic conditions < 2 years
Unwilling or unable to comply with all study procedures
Trial design
Design model
Parallel
Treatments tested in this trial
TEVAR
Procedure/SurgeryThoracic endovascular aortic repair
Guideline directed medical therapy and surveillance of dissection
Other interventionRoutine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.
Treatment groups
1,100 Participants
are divided into 2 treatment groupsGroup A: Upfront TEVAR plus Medical TherapyExperimental treatment 2 interventions
Group B: Medical Therapy with surveillance for deteriorationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
All-cause death or major aortic complications (MAC)
The primary endpoint is a composite of all-cause death or major aortic complications (MAC). MACs are defined as: * Aortic rupture * Malperfusion syndrome * New aortic tear requiring intervention, * Retrograde aortic dissection, * Dependence on outpatient dialysis (chronic) * Major amputation (above ankle) * Tracheostomy * fistula formation (e.g., aorto-esophageal, aorto-tracheal) * Spinal Cord Ischemia with paralysis or paresis * Stroke * AD-related intervention in either group defined as: * Open TAA/TAAA Repair * Fenestrated and/or Branched Endovascular Repair of TAAA * Repeat TEVAR
Time frame
Last follow-up timepoint. Differential follow-up with median of about 4 yearsSecondary outcomes
1
Quality of Life, as measured by the Abdominal Aortic Aneurysm Quality of Life questionnaire (AAAQol)
An adapted version of the AAAQol survey and the PROMIS-16 will be used to assess general and aortic specific quality of life. The AAAQol questionnaire was specifically developed and validated on patients with abdominal aortic aneurysms and measures both the physical and emotional impact of either 1) having an abdominal aortic aneurysm or 2) having surgical or endovascular therapy for an abdominal aortic aneurysm. This metric has been shown to be valid and responsive in abdominal aortic aneurysm. While it has not been tested in aortic dissection, its questions assess the same domains shown to be significantly impacted in patients with aortic dissection.
Time frame
Last follow-up timepoint. Differential follow-up with median of about 4 years2
Cumulative incidence of cardiovascular (CV) hospitalizations
CV hospitalization will be defined as hospitalization \>/= 24 hours for any cardiovascular cause.
Time frame
Last follow-up timepoint. Differential follow-up with median of about 4 years3
Mean number of cardiovascular (CV) hospitalizations
CV hospitalization will be defined as hospitalization \>/= 24 hours for any cardiovascular cause.
Time frame
Last follow-up timepoint. Differential follow-up with median of about 4 years4
Incidence of cardiovascular death
Death from any cardiovascular cause.
Time frame
Last follow-up timepoint. Differential follow-up with median of about 4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborator
State University of New York - Downstate Medical Center
Collaborator
Oregon Health and Science University
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov