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NCT Number: NCT06087029

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.

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Key information

Conditions

Type B Aortic Dissection

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUM - Centre hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEVAR

Procedure

Thoracic endovascular aortic repair

Guideline directed medical therapy and surveillance of dissection

Other

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

Primary outcomes

  1. 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

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

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

    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.

  2. Cumulative incidence of cardiovascular (CV) hospitalizations

    Time frame: 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.

  3. Mean number of cardiovascular (CV) hospitalizations

    Time frame: 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.

  4. Incidence of cardiovascular death

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

    Death from any cardiovascular cause.

  5. Incidence of all-cause death

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

    Death from any case

  6. Cumulative incidence of major aortic complications (MAC)

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

    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

  7. Incidence of stroke

    Time frame: 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.

  8. Incidence of paraplegia or paraparesis

    Time frame: 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.

  9. Incidence of vascular access injury requiring surgical repair

    Time frame: 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.

  10. Incidence of aortobronchial / aortoesophageal fistula

    Time frame: 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).

  11. Incidence of retrograde type A dissection

    Time frame: 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.

  12. Incidence of aortic-related death

    Time frame: 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.

  13. Number of days alive and out of the hospital

    Time frame: 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).

  14. Incidence of secondary percutaneous interventions after TEVAR

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

    Any secondary percutaneous intervention after TEVAR

Study contacts

Contact information is provided by the study sponsor or research team.

Kady-Ann Steen-Burrell, Ph.D.

CONTACT

[email protected]

919-530-9711

Megan Roebuck, M.S.

CONTACT

[email protected]

919-316-0628

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Oregon Health and Science University
  • State University of New York - Downstate Medical Center
  • The University of Texas Health Science Center, Houston

Registry information

Official study title

IMPRoving Outcomes in Vascular DisEase- Aortic Dissection

Acronym: IMPROVE-AD

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Oct 17, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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