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Should we operate sooner on enlarged aortas? major trial aims to settle debate

NCT ID NCT03536312

Disease control Sponsor: Ottawa Heart Institute Research Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looks at patients with an ascending aorta that is enlarged (5.0 to 5.4 cm) but not yet at the traditional surgery threshold. Half will have early surgery to replace the aorta, and half will be closely monitored. Researchers will compare death rates and dangerous aortic events over two years to see which approach is safer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Thoracic aortic surgery (procedure to replace the enlarged section of the aorta)
What this could lead to
If early surgery proves better, it could guide doctors to operate sooner on patients with moderately enlarged aortas, potentially preventing deadly tears or ruptures.
What could go wrong
This is a mid-stage trial with 610 participants, so results may not apply to everyone. Surgery itself carries risks like death or stroke, and the surveillance group may still need surgery later.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 610 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2018

Expected to finish

May 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 79 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients between the age of 18 and 79 inclusive. 2. Ascending aortic aneurysm between 5.0cm and 5.4cm in maximal diameter as measured by CT with contrast. 3. Patients with ascending aortic aneurysm with a diameter of 4.5 cm - 4.9 cm will be observed with serial CT, and will be considered for enrollment into the trial once the aneurysm reaches 5.0 cm. Exclusion Criteria: 1. Patients who refused to be randomized 2. Patients with symptomatic attributable to ascending aortic aneurysms 3. Patients who are unable to provide informed consents 4. Patients who are unable to attend for regular follow-up/ remain compliant with protocol 5. Previous cardiac surgery 6. Patients whose primary indication for cardiac surgery is non-AsAA related 7. Known AsAA expansion rate exceeding 0.5 cm/year during the past 5 years 8. Arch aneurysms with no ascending aorta involvement (no aneurysmal segments before the innominate artery) 9. Ascending aortic and arch aneurysm with descending thoracic aorta involvement 10. Patients with known connective tissue disease (E.g. Marfan syndrome, Loey-Dietz syndrome, Turner syndrome etc) syndrome, etc.) 11. Patients with possible genetic aortopathies (eg known family history of aortic aneurysms/premature aortic dissections/ruptures) 12. Patients with inflammatory arteritis (e.g. takayasu's arteritis, syphilitic arteritis, etc.) 13. Female patients who are pregnant or planning to become pregnant 14. Patients who have a history or presence of a medical condition or disease or psychiatric condition that in the investigator's assessment would render the subject ineligible for study participation. 15. Patients who, in the opinion of the investigator, are deemed unfit for surgery for reasons that may include: * Severe pulmonary disease * Cr = 250umol/L * Child Pugh Class B or C * NYHA III or IV * MI within the last 6 months * Major surgical procedure or angioplasty within 3 months * Expected survival less than 5 years because of other disease (e.g. invasive cancer)

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Conditions

The condition(s) this trial relates to.

Aneurysm aneurysm or dilatation of ascending aorta Aneurysm, Ascending Aorta

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ascending aorta aneurysm Ascending aortic aneurysm enlargement

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baylor Scott & White Research Institute

    RECRUITING

    Plano, Texas, 75093, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Hamilton General Hospital

    RECRUITING

    Hamilton, Ontario, Canada

  • Health Sciences North

    RECRUITING

    Greater Sudbury, Ontario, Canada

  • Horizon Health Network

    RECRUITING

    Saint John, New Brunswick, E2L 4L2, Canada

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Institut universitaire de cardiologie et de pneumologie de Québec

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

  • London Health Sciences Centre

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • MUSC Health University Medical Center

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mazankowski Alberta Heart Institute

    RECRUITING

    Edmonton, Alberta, T6G 0M9, Canada

  • McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H3H2R9, Canada

  • Montreal Heart Institute

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

  • Nova Scotia Health Authority

    RECRUITING

    Halifax, Nova Scotia, B3S 0H6, Canada

  • Ohio State University Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • St. Michael's Hospital

    NOT_YET_RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • The Trustees of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • The Valley Hospital, Inc

    RECRUITING

    Ridgewood, New Jersey, 07652, United States

  • Toronto General Hospital

    RECRUITING

    Toronto, Ontario, Canada

  • University Hospitals Cleveland

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Calgary

    RECRUITING

    Calgary, Alberta, T2N 2T9, Canada

  • University of California at San Francisco Medical Center

    RECRUITING

    San Francisco, California, 94121, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Ottawa Heart Institute

    RECRUITING

    Ottawa, Ontario, K1Y 4W7, Canada

  • University of Texas Health Science Centre

    RECRUITING

    Houston, Texas, 77030, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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