IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
IMPROVE-AD
3 other identifiers
interventional
1,100
2 countries
63
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2023
CompletedFirst Posted
Study publicly available on registry
October 17, 2023
CompletedStudy Start
First participant enrolled
April 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2030
April 29, 2026
February 1, 2026
6.1 years
October 11, 2023
April 28, 2026
Conditions
Keywords
Outcome Measures
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
Last follow-up timepoint. Differential follow-up with median of about 4 years
Secondary Outcomes (14)
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
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 cardiovascular death
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
- +9 more secondary outcomes
Study Arms (2)
Upfront TEVAR plus Medical Therapy
EXPERIMENTALParticipants 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
ACTIVE COMPARATORParticipants 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.
Interventions
Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Honorhealth
Phoenix, Arizona, 85020, United States
Memorial Care Long Beach Medical Center
Long Beach, California, 90806, United States
Keck Medical Center of USC
Los Angeles, California, 90033, United States
University of California San Diego
San Diego, California, 92110, United States
University of California
San Francisco, California, 94143, United States
Stanford University Medical Center
Stanford, California, 94305, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Memorial Hospital Central
Colorado Springs, Colorado, 90803, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Yale University
New Haven, Connecticut, 06510, United States
University of Florida Health
Gainesville, Florida, 32608, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Northwestern University
Chicago, Illinois, 60611, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Indiana University Methodist Hospital
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MaineHealth
Scarborough, Maine, 04101, United States
Johns Hopkins University
Baltimore, Maryland, 21230, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Massachusetts Memorial
Worcester, Massachusetts, 01655, United States
University of Michigan Health
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Spectrum Health and Hospitals and Corewell
Grand Rapids, Michigan, 49503, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Missouri Health Care
Columbia, Missouri, 65212, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Rutgers UH Vascular Center
Jersey City, New Jersey, 07302, United States
Maimonides Medical Center
Brooklyn, New York, 11219, United States
NYU Langone Health
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
St. Francis Hospital and Heart Center
Roslyn, New York, 11576, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
SUNY Upstate Medical University
Syracuse, New York, 13120, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Sanger Heart & Vascular Institute
Charlotte, North Carolina, 28201, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Harrington Heart and Vascular Institute
Cleveland, Ohio, 44106, United States
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
UT Dell Medical School- Ascension
Austin, Texas, 78712, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75226, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
The University of Texas Health Houston
Houston, Texas, 77030, United States
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507, United States
University of Washington
Seattle, Washington, 98104, United States
CAMC Clinical Trials Center
Charleston, West Virginia, 25304, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
CHUM - Centre hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0C1, Canada
McGill University Medical Center
Montreal, Quebec, H3A 0G4, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manesh R Patel, M.D.
Duke University
- PRINCIPAL INVESTIGATOR
Firas F Mussa, M.D.
The University of Texas at Houston
- PRINCIPAL INVESTIGATOR
Panos Kougias, M.D.
The State University of New York at Downstate
- PRINCIPAL INVESTIGATOR
Sreekanth Vemulapalli, M.D.
Duke University
- PRINCIPAL INVESTIGATOR
Sean O'Brien, Ph.D.
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2023
First Posted
October 17, 2023
Study Start
April 14, 2024
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 30, 2030
Last Updated
April 29, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
- Time Frame
- 2 years
- Access Criteria
- The methods for restricting access will also need to be determined, either with password access and/or with executed Data Agreements. Related to the restricted use of data is the need to specify appropriately in informed consent forms that the study participant's de-identified data may be made available to other researchers.
The Statistical and data analytic center (SDCC) will submit to the NHLBI data repository de-identified Limited Access Datasets (LADs) and associated documentation, for use by other investigators. The LADs and documentation will be submitted within 2 years after publication of the primary results manuscript. Documentation will include copies of the case report forms; a list of derived variables and the formulas used to create them; and a codebook providing for each variable the variable name, coding conventions, and distribution of values. It will also include a list of data modifications made when creating the LAD, and a copy of the informed consent template, so that future use of the data will be consistent with the consent provided by the study subjects.The goal is to make data available to other investigators while protecting the rights and privacy of the subjects who participated in the studies. The SDCC will anonymize the datasets.