AzTrials
AzTrials

Type B Aortic DissectionIMPROVE-ADNCT06087029

IMPRoving Outcomes in Vascular DisEase - Aortic Dissection

A study testing TEVAR and Guideline directed medical therapy and surveillance of dissection in people with Type B Aortic Dissection, run by Duke University at 66 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Type B Aortic Dissection
What is being tested?
TEVAR and Guideline directed medical therapy and surveillance of dissection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,100 participants
Where
66 sitesin 2 countries
Study dates
14 Apr 2024to 30 Jun 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

66 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Megan Roebuck, M.S. contact

919-316-0628

megan.roebuck@duke.edu

Kady-Ann Steen-Burrell, Ph.D. contact

919-530-9711

kady.ann.steen.burrell@duke.edu

66 sites in 2 countries

United States64 sites, 53 recruiting

  • University of Michigan Health

    Ann Arbor, Michigan, 48109

    Bo Yang, MD

    Bo Yang, MD

    Recruiting

  • University of Colorado Denver

    Aurora, Colorado, 80045

    Brett Reece, MD

    Brett Reece

    Recruiting

  • UT Dell Medical School- Ascension

    Austin, Texas, 78712

    Madeline Gleason, 512-324-3434

    George Arnaoutakis, MD

    Recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21230

    Caitlin Hicks, MD

    Caitlin Hicks, MD

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

    Adam Beck, MD

    Adam Beck, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Research Office, 617-726-8875

    Matthew Eagleton, MD

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    BWH Vascular Surgery Research, 617-525-8555

    Matthew T Menard, MD

    Recruiting

  • Maimonides Medical Center

    Brooklyn, New York, 11219

    Withdrawn

  • Cooper University Hospital

    Camden, New Jersey, 08103

    Jonelle O'Shea, 856-342-2150

    Philip Batista, MD

    Recruiting

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina, 27599

    Withdrawn

  • CAMC Clinical Trials Center

    Charleston, West Virginia, 25304

    Kristi Sutphin, 304-388-9944

    Shadi Abu-halimah, MD

    Recruiting

  • Sanger Heart & Vascular Institute

    Charlotte, North Carolina, 28201

    Withdrawn

  • Northwestern University

    Chicago, Illinois, 60611

    Andrea Silverman, 312-926-4000

    Mark Eskandari, MD

    Recruiting

  • The University of Chicago

    Chicago, Illinois, 60637

    Withdrawn

  • Harrington Heart and Vascular Institute

    Cleveland, Ohio, 44106

    Amy Kluge, 216-844-2988

    Jae S Cho, MD

    Recruiting

  • Memorial Hospital Central

    Colorado Springs, Colorado, 90803

    Terminated

  • University of Missouri Health Care

    Columbia, Missouri, 65212

    Brianna Ledbetter, 573-884-7569

    Jonathan Bath, MD

    Recruiting

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210

    Xiaoyi Teng, MD

    Xiaoyi Teng, MD

    Recruiting

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75226

    John Eidt, MD

    John Eidt, MD

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Emma Bryant, 214-648-6743

    Michael Shih, MD

    Recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    Research Office, 313-916-8006

    Loay Kabbani, MD

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    G. Chad Hughes, MD

    G. Chad Hughes, MD

    Recruiting

  • University of Florida Health

    Gainesville, Florida, 32608

    Active, not recruiting

  • Spectrum Health and Hospitals and Corewell

    Grand Rapids, Michigan, 49503

    Eanas Yassa, MD

    Eanas Yassa, MD

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06102

    Marianne McCarthy, 860-972-1788

    Mohiuddin Cheema, MD

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Solange Basagoitia, 832-301-1168

    Saba Khan, 832-301-1168

    Recruiting

  • The University of Texas Health Houston

    Houston, Texas, 77030

    Mariano Montemayor, 713-486-5194

    Naveed Saqib, MD

    Recruiting

  • Indiana University Methodist Hospital

    Indianapolis, Indiana, 46202

    Raghu Motaganahalli, MD

    Raghu Motaganahalli, MD

    Recruiting

  • Rutgers UH Vascular Center

    Jersey City, New Jersey, 07302

    Karim Salem, MD

    Karim Salem, MD

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    William Poulson, MD

    William Poulson, MD

    Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

    Venkat Kalapatapu, MD

    Venkat Kalapatapu, MD

    Recruiting

  • Memorial Care Long Beach Medical Center

    Long Beach, California, 90806

    Rodney White, MD

    Rodney White, MD

    Recruiting

  • Keck Medical Center of USC

    Los Angeles, California, 90033

    Alyssa Pyun, MD

    Alyssa Pyun, MD

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792

    John Rectenwald, MD

    John Rectenwald, MD

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Beth Weseman, 414-955-1810

    Joe Hart, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Surgery Clinical Trials Office, 612-624-7463

    Nolan Cirillo-Penn, MD

    Recruiting

  • Yale University

    New Haven, Connecticut, 06510

    David Kuwayama, MD

    David Kuwayama, MD

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Gregory Magee, MD

    Gregory Magee, MD

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Bridget Coyle, 212-241-4461

    Rami Tadros, MD

    Recruiting

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia, 23507

    Kara Wiggins, 757-388-7511

    David Dexter, MD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Withdrawn

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Nimesh Desai, MD

    Nimesh Desai, MD

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Babak Abai, MD

    Babak Abai, MD

    Recruiting

  • Honorhealth

    Phoenix, Arizona, 85020

    General Office Number, 480-323-1046

    Hasan Aldailami, MD

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    Erin Cochran, 412-647-8467

    Derek Serna-Gallegos, MD

    Recruiting

  • Baylor Scott & White The Heart Hospital - Plano

    Plano, Texas, 75093

    Dennis Gable, MD

    Dennis Gable, MD

    Recruiting

  • Kaiser Permanente San Francisco

    Pleasanton, California, 94588

    Elizabeth Lancaster, MD

    Elizabeth Lancaster, MD

    Recruiting

  • Providence Heart and Vascular Institute

    Portland, Oregon, 97213

    Brant Ullery, MD

    Brant Ullery, MD

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Amie Lorisch, 971-349-6659

    Sherene Shalhub, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Withdrawn

  • University of Rochester Medical Center

    Rochester, New York, 14642

    Mary Bourret, 585-276-1738

    Doran Mix, MD

    Recruiting

  • St. Francis Hospital and Heart Center

    Roslyn, New York, 11576

    Timothy Carter, MD

    Timothy Carter, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84112

    Julie Hales, 801-587-1450

    Nathan Droz, MD

    Recruiting

  • University of California San Diego

    San Diego, California, 92110

    Withdrawn

  • University of California

    San Francisco, California, 94143

    Alexis Callanta, 415-353-4368

    Jade Hiramoto, MD

    Recruiting

  • MaineHealth

    Scarborough, Maine, 04101

    Monica Palmeri, 207-662-2090

    Kristina Giles, MD

    Recruiting

  • University of Washington

    Seattle, Washington, 98104

    Benjamin Starnes, MD

    Benjamin Starnes, MD

    Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

    Rebecca Owens, 217-545-7321

    Laura Healy, MD

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Withdrawn

  • Stanford University Medical Center

    Stanford, California, 94305

    Withdrawn

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

    Apostolos Tassiopoulos, MD

    Apostolos Tassiopoulos, MD

    Recruiting

  • SUNY Upstate Medical University

    Syracuse, New York, 13120

    Maria Walker, 315-464-8272

    Palma Shaw, MD

    Recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606

    Eric Johnson, 813-844-4686

    Halim Yammine, MD

    Recruiting

  • University of Massachusetts Memorial

    Worcester, Massachusetts, 01655

    Shauneen Valliere, 508-856-1767

    Andres Schanzer, MD

    Recruiting

Other trials in United States

Canada2 sites, 2 recruiting

  • CHUM - Centre hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 0C1

    Benjamin Orcese, 514-890-8000 ext. 30988

    Laura Drudi, MD

    Recruiting

  • McGill University Medical Center

    Montreal, Quebec, H3A 0G4

    Hila Tabrizian, 514-718-5025

    Robert James Doonan, MD

    Recruiting

Other trials in Canada

About this study

Official title: IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

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.

Read the 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.

Being tested
TEVAR, Guideline directed medical therapy and surveillance of dissection
Keywords
TEVAR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEVARProcedure or surgery

    Thoracic endovascular aortic repair

  • Guideline directed medical therapy and surveillance of dissectionOther

    Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.

Study groups in NCT06087029
Study groupRoleWhat they receive
Upfront TEVAR plus Medical TherapyExperimentalParticipants 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).
Receives: Procedure: TEVAR; Other: Guideline directed medical therapy and surveillance of dissection
Medical Therapy with surveillance for deteriorationActive 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.
Receives: Other: Guideline directed medical therapy and surveillance of dissection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Last follow-up timepoint. Differential follow-up with median of about 4 years

Secondary outcomes (14)

  1. Quality of Life, as measured by the Abdominal Aortic Aneurysm Quality of Life questionnaire (AAAQol)

    An adapted version of the AAAQol survey and the PROMIS-16 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.

    Measured: Last follow-up timepoint. Differential follow-up with median of about 4 years

  2. Cumulative incidence of cardiovascular (CV) hospitalizations

    CV hospitalization will be defined as hospitalization >/= 24 hours for any cardiovascular cause.

    Measured: Last follow-up timepoint. Differential follow-up with median of about 4 years

  3. Mean number of cardiovascular (CV) hospitalizations

    CV hospitalization will be defined as hospitalization >/= 24 hours for any cardiovascular cause.

    Measured: Last follow-up timepoint. Differential follow-up with median of about 4 years

  4. Incidence of cardiovascular death

    Death from any cardiovascular cause.

    Measured: Last follow-up timepoint. Differential follow-up with median of about 4 years

  5. Incidence of all-cause death

    Death from any case

    Measured: Last follow-up timepoint. Differential follow-up with median of about 4 years

  6. Cumulative incidence of major aortic complications (MAC)

    Composite endpoint. 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

    Measured: Last follow-up timepoint. Differential follow-up with median of about 4 years

  7. Incidence of stroke

    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.

    Measured: Last follow-up timepoint. Differential follow-up with median of about 4 years

  8. Incidence of paraplegia or paraparesis

    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.

    Measured: Last follow-up timepoint. Differential follow-up with median of about 4 years

  9. Incidence of vascular access injury requiring surgical repair

    Defined as any open surgical procedure to treat a vascular injury at the site of vascular access for a previous endovascular procedure.

    Measured: Last follow-up timepoint. Differential follow-up with median of about 4 years

  10. Incidence of aortobronchial / aortoesophageal fistula

    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).

    Measured: Last follow-up timepoint. Differential follow-up with median of about 4 years

  11. Incidence of retrograde type A dissection

    Defined as any new ascending arch, or descending dissection contiguous with and proximal to the original presenting anatomy as confirmed by imaging.

    Measured: Last follow-up timepoint. Differential follow-up with median of about 4 years

  12. Incidence of aortic-related death

    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.

    Measured: Last follow-up timepoint. Differential follow-up with median of about 4 years

  13. Number of days alive and out of the hospital

    Defined as the number of days alive minus the number of days in the hospital over 4 years (primary analysis).

    Measured: Last follow-up timepoint. Differential follow-up with median of about 4 years

  14. Incidence of secondary percutaneous interventions after TEVAR

    Any secondary percutaneous intervention after TEVAR

    Measured: Last follow-up timepoint. Differential follow-up with median of about 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2023
  2. Study start14 Apr 2024
  3. Primary completion1 Jun 2030 (estimated)
  4. Study completion30 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06087029
Sponsor's protocol ID
Pro00113329
Other IDs
4UH3HL165017-02, 5U24HL165029-02
Acronym
IMPROVE-AD
Status last verified
Feb 2026
First submitted
11 Oct 2023
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing TEVAR and Guideline directed medical therapy and surveillance of dissection in people with Type B Aortic Dissection, run by Duke University at 66 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Megan Roebuck, M.S. (919-316-0628, megan.roebuck@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause death or major aortic complications (MAC) (time frame: Last follow-up timepoint. Differential follow-up with median of about 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06087029.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in