IMPRoving Outcomes in Vascular DisEase- Aortic Dissection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,100
- Locations
- 110
- Primary Endpoint
- All-cause death or major aortic complications (MAC)
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Upfront TEVAR plus Medical Therapy
Participants randomized to upfront TEVAR will receive a commercially available device customized to their individual anatomical requirements. Stent-graft implantation will be performed either in the operating room with appropriate digital imaging equipment to allow fluoroscopic and trans-esophageal echo (TEE) guidance or the catheterization laboratory, angiographic suite (with digital angiographic equipment).
Intervention: TEVAR (Procedure)
Upfront TEVAR plus Medical Therapy
Participants randomized to upfront TEVAR will receive a commercially available device customized to their individual anatomical requirements. Stent-graft implantation will be performed either in the operating room with appropriate digital imaging equipment to allow fluoroscopic and trans-esophageal echo (TEE) guidance or the catheterization laboratory, angiographic suite (with digital angiographic equipment).
Intervention: Guideline directed medical therapy and surveillance of dissection (Other)
Medical Therapy with surveillance for deterioration
Participants randomized to upfront Medical Therapy with Surveillance for Deterioration will be treated per routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.
Intervention: Guideline directed medical therapy and surveillance of dissection (Other)
Outcomes
Primary Outcomes
All-cause death or major aortic complications (MAC)
Time Frame: Last follow-up timepoint. Differential follow-up with median of about 4 years
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
Secondary Outcomes
- Cumulative incidence of cardiovascular (CV) hospitalizations(Last follow-up timepoint. Differential follow-up with median of about 4 years)
- Mean number of cardiovascular (CV) hospitalizations(Last follow-up timepoint. Differential follow-up with median of about 4 years)
- Incidence of all-cause death(Last follow-up timepoint. Differential follow-up with median of about 4 years)
- Incidence of cardiovascular death(Last follow-up timepoint. Differential follow-up with median of about 4 years)
- Cumulative incidence of major aortic complications (MAC)(Last follow-up timepoint. Differential follow-up with median of about 4 years)
- Incidence of stroke(Last follow-up timepoint. Differential follow-up with median of about 4 years)
- Incidence of vascular access injury requiring surgical repair(Last follow-up timepoint. Differential follow-up with median of about 4 years)
- Incidence of paraplegia or paraparesis(Last follow-up timepoint. Differential follow-up with median of about 4 years)
- Incidence of retrograde type A dissection(Last follow-up timepoint. Differential follow-up with median of about 4 years)
- Incidence of aortic-related death(Last follow-up timepoint. Differential follow-up with median of about 4 years)
- Number of days alive and out of the hospital(Last follow-up timepoint. Differential follow-up with median of about 4 years)
- Quality of Life, as measured by the Abdominal Aortic Aneurysm Quality of Life questionnaire (AAAQol)(Last follow-up timepoint. Differential follow-up with median of about 4 years)
- Incidence of aortobronchial / aortoesophageal fistula(Last follow-up timepoint. Differential follow-up with median of about 4 years)
- Incidence of secondary percutaneous interventions after TEVAR(Last follow-up timepoint. Differential follow-up with median of about 4 years)