IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TEVAR, Guideline directed medical therapy and surveillance of dissection.
- Who it may be relevant to
- Registry conditions: Type B Aortic Dissection. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
IMPRoving Outcomes in Vascular DisEase- Aortic Dissection
Overview
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.
Detailed description
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.
Interventions
- Procedure TEVAR
Thoracic endovascular aortic repair - Other Guideline directed medical therapy and surveillance of dissection
Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.
Primary outcome measures
- All-cause death or major aortic complications (MAC) [Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years]
Secondary outcome measures (12)
- Quality of Life, as measured by the Abdominal Aortic Aneurysm Quality of Life questionnaire (AAAQol) [Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Cumulative incidence of cardiovascular (CV) hospitalizations [Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Mean number of cardiovascular (CV) hospitalizations [Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of cardiovascular death [Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of all-cause death [Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Cumulative incidence of major aortic complications (MAC) [Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of stroke [Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of paraplegia or paraparesis [Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of vascular access injury requiring surgical repair [Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of aortobronchial / aortoesophageal fistula [Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of retrograde type A dissection [Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years]
- Incidence of aortic-related death [Time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- Known patient history of genetic aortopathy
- Penetrating Aortic Ulcer without concomitant uTBAD
- Intramural hematoma without concomitant uTBAD
- Iatrogenic (traumatic) aortic dissection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 61 centers
- University of Alabama at Birmingham — Birmingham
- Honorhealth — Phoenix
- Memorial Care Long Beach Medical Center — Long Beach
- Keck Medical Center of USC — Los Angeles
- University of California San Diego — San Diego
- University of California — San Francisco
- Stanford University Medical Center — Stanford
- University of Colorado Denver — Aurora
- … and 53 more centers
Canada · 2 centers
- CHUM - Centre hospitalier de l'Universite de Montreal — Montreal
- McGill University Medical Center — Montreal
Identifiers
NCT: NCT06087029 · Pro00113329 · 4UH3HL165017-02 · 5U24HL165029-02