IMPRoving Outcomes in Vascular DisEase- Aortic Dissection
- Conditions
- Type B Aortic Dissection
- Interventions
- Procedure: TEVAROther: Guideline directed medical therapy and surveillance of dissection
- Registration Number
- NCT06087029
- Lead Sponsor
- Duke University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1100
- Age > 21 years
- 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)
- Acuity: within 48 hours - 6 weeks of index admission
- Ability to provide written informed consent and comply with the protocol
- Investigator believes anatomy is suitable for TEVAR
- 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 including serial imaging follow-up
- Known patient history of genetic aortopathy
- Penetrating Aortic Ulcer and Intramural hematoma
- Iatrogenic (traumatic) aortic dissection
- Prior surgery for aortic dissection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Upfront TEVAR plus Medical Therapy Guideline directed medical therapy and surveillance of dissection 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). Medical Therapy with surveillance for deterioration Guideline directed medical therapy and surveillance of dissection 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. Upfront TEVAR plus Medical Therapy TEVAR 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).
- Primary Outcome Measures
Name Time Method All-cause death or major aortic complications (MAC) 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,
* 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 (power 0-2)
* Stroke modified Rankin Scale 2-5
* AD-related intervention in either group defined as:
* Open TAA/TAAA Repair
* Fenestrated and/or Branched Endovascular Repair of TAAA
* Repeat TEVAR
- Secondary Outcome Measures
Name Time Method Cumulative incidence of cardiovascular (CV) hospitalizations Last follow-up timepoint. Differential follow-up with median of about 4 years CV hospitalization will be defined as hospitalization \>/= 24 hours for any cardiovascular cause.
Number of days alive and out of the hospital Last follow-up timepoint. Differential follow-up with median of about 4 years Defined as the number of days alive minus the number of days in the hospital over 4 years (primary analysis).
Incidence of stroke Last follow-up timepoint. Differential follow-up with median of about 4 years Defined as a focal neurological deficit that could be attributed to a vascular territory and lasted \>24 hours or was associated with a new lesion on computed tomography scan or magnetic resonance imaging.
Incidence of aortobronchial / aortoesophageal fistula Last follow-up timepoint. Differential follow-up with median of about 4 years Defined as fistulous connection between the aorta and bronchus as confirmed by chest imaging or direct visualization (surgical or bronchoscopic). Aortoesophageal fistula is defined as a fistulous connection between the aorta and the esophagus as confirmed by chest imaging or direct visualization (surgical or endoscopically).
Incidence of retrograde type A dissection Last follow-up timepoint. Differential follow-up with median of about 4 years Defined as any new ascending arch, or descending dissection contiguous with and proximal to the original presenting anatomy as confirmed by imaging.
Mean number of cardiovascular (CV) hospitalizations Last follow-up timepoint. Differential follow-up with median of about 4 years CV hospitalization will be defined as hospitalization \>/= 24 hours for any cardiovascular cause.
Cumulative incidence of aortic-related hospitalizations Last follow-up timepoint. Differential follow-up with median of about 4 years Aortic-related hospitalizations include hospitalizations for: aortic rupture, malperfusion, new aortic tear requiring intervention, retrograde aortic dissection, admission for BP or pain control despite adequate medical therapy, stroke, or intervention for AD, aortic interventions including open TAA/TAAA repair or fenestrated and/or branched endovascular repair of TAAA or repeat TEVAR in either group.
Incidence of cardiovascular death Last follow-up timepoint. Differential follow-up with median of about 4 years Death from any cardiovascular cause.
Incidence of all-cause mortality Last follow-up timepoint. Differential follow-up with median of about 4 years Death from any case
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 An adapted version of the AAAQol survey and the Short Form 6 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.
Incidence of paraplegia or paraparesis Last follow-up timepoint. Differential follow-up with median of about 4 years Defined as including: 1) flaccid paraplegia (no lower extremity movement), or lower extremity movement without gravity, or lower extremity movement with gravity, or standing with assistance or walking with assistance (Tarlov scores 0-4).
Incidence of aortic-related death, excluding sudden cardiac deaths Last follow-up timepoint. Differential follow-up with median of about 4 years Aortic-related death will be defined as death within 30 days of 1) diagnosis of aortic dissection 2) any aortic intervention or 3) ruptured aortic aneurysm. This endpoint does not include sudden cardiac deaths. Sudden cardiac death will be defined as unexpected death with a preceding symptom duration of \< 24 hours.
Incidence of secondary percutaneous interventions after TEVAR Last follow-up timepoint. Differential follow-up with median of about 4 years Any secondary percutaneous intervention after TEVAR
Mean number of aortic-related hospitalizations Last follow-up timepoint. Differential follow-up with median of about 4 years Aortic-related hospitalizations include hospitalizations for: aortic rupture, malperfusion, new aortic tear requiring intervention, retrograde aortic dissection, admission for BP or pain control despite adequate medical therapy, stroke, or intervention for AD, aortic interventions including open TAA/TAAA repair or fenestrated and/or branched endovascular repair of TAAA or repeat TEVAR in either group.
Incidence of vascular access injury requiring surgical repair Last follow-up timepoint. Differential follow-up with median of about 4 years Defined as any open surgical procedure to treat a vascular injury at the site of vascular access for a previous endovascular procedure.
Incidence of aortic-related death, including sudden cardiac deaths Last follow-up timepoint. Differential follow-up with median of about 4 years Aortic-related death will be defined as death within 30 days of 1) diagnosis of aortic dissection 2) any aortic intervention or 3) ruptured aortic aneurysm. This endpoint includes sudden cardiac deaths. Sudden cardiac death will be defined as unexpected death with a preceding symptom duration of \< 24 hours.
Trial Locations
- Locations (57)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California San Diego
🇺🇸San Diego, California, United States
University of California
🇺🇸San Francisco, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Memorial Hospital Central
🇺🇸Colorado Springs, Colorado, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Massachusetts Memorial
🇺🇸Worcester, Massachusetts, United States
Spectrum Health and Hospitals and Corewell
🇺🇸Grand Rapids, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Missouri Health Care
🇺🇸Columbia, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Sanger Heart & Vascular Institute
🇺🇸Charlotte, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
UT Southwestern- Dallas
🇺🇸Dallas, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Sentara Cardiovascular Research Institute
🇺🇸Norfolk, Virginia, United States
CAMC Clinical Trials Center
🇺🇸Charleston, West Virginia, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Honorhealth
🇺🇸Phoenix, Arizona, United States
Memorial Care Long Beach Medical Center
🇺🇸Long Beach, California, United States
Keck Medical Center of USC
🇺🇸Los Angeles, California, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of Florida Health
🇺🇸Gainesville, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Indiana University Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
MaineHealth
🇺🇸Scarborough, Maine, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan Health
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Rutgers UH Vascular Center
🇺🇸Newark, New Jersey, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
St. Francis Hospital and Heart Center
🇺🇸Roslyn, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
University of North Carolina Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
UT Dell Medical School- Ascension
🇺🇸Austin, Texas, United States
Baylor Scott & White Research Institution
🇺🇸Dallas, Texas, United States
The University of Texas Health Houston
🇺🇸Houston, Texas, United States
Baylor Scott & White The Heart Hospital - Plano
🇺🇸Plano, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Washington
🇺🇸Seattle, Washington, United States