Clinical trial NCT06087029: IMPRoving Outcomes in Vascular DisEase- Aortic Dissection
Official title: IMPRoving Outcomes in Vascular DisEase- Aortic Dissection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type B Aortic Dissection
Keywords: TEVAR
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center, Houston
name: State University of New York - Downstate Medical Center
name: Oregon Health and Science University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-10-17
Enrollment: 1100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause death or major aortic complications (MAC)
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary outcomes:
measure: Quality of Life, as measured by the Abdominal Aortic Aneurysm Quality of Life questionnaire (AAAQol)
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
measure: Cumulative incidence of cardiovascular (CV) hospitalizations
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
measure: Mean number of cardiovascular (CV) hospitalizations
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
measure: Incidence of cardiovascular death
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
measure: Incidence of all-cause mortality
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
measure: Cumulative incidence of aortic-related hospitalizations
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
measure: Mean number of aortic-related hospitalizations
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
measure: Incidence of stroke
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
measure: Incidence of paraplegia or paraparesis
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
measure: Incidence of vascular access injury requiring surgical repair
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
measure: Incidence of aortobronchial / aortoesophageal fistula
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
measure: Incidence of retrograde type A dissection
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
measure: Incidence of aortic-related death, including sudden cardiac deaths
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
measure: Incidence of aortic-related death, excluding sudden cardiac deaths
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
measure: Number of days alive and out of the hospital
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
measure: Incidence of secondary percutaneous interventions after TEVAR
timeFrame: Last follow-up timepoint. Differential follow-up with median of about 4 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Honorhealth
state: Arizona
city: Long Beach
country: United States
facility: Memorial Care Long Beach Medical Center
state: California
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Francisco
country: United States
facility: University of California
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Colorado Springs
country: United States
facility: Memorial Hospital Central
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Methodist Hospital
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Scarborough
country: United States
facility: MaineHealth
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health and Hospitals and Corewell
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Newark
country: United States
facility: Rutgers UH Vascular Center
state: New Jersey
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital and Heart Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Sanger Heart & Vascular Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Austin
country: United States
facility: UT Dell Medical School- Ascension
state: Texas
city: Dallas
country: United States
facility: Baylor Scott & White Research Institution
state: Texas
city: Dallas
country: United States
facility: UT Southwestern- Dallas
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Houston
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White The Heart Hospital - Plano
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Norfolk
country: United States
facility: Sentara Cardiovascular Research Institute
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Charleston
country: United States
facility: CAMC Clinical Trials Center
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Duke University
name: Manesh R Patel, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas at Houston
name: Firas F Mussa, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The State University of New York at Downstate
name: Panos Kougias, M.D.
role: PRINCIPAL_INVESTIGATOR
References: