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Mini ultrasound inside aorta could save organs after emergency surgery

NCT ID NCT04907071

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested whether a small ultrasound device placed inside the aorta can quickly identify organs not getting enough blood after surgery for aortic dissection (a tear in the main artery). The device was used in 50 patients right after repairing the tear. The goal was to see if real-time imaging could catch blood-flow problems before they cause permanent damage, such as kidney failure or bowel injury. The study measured safety and effectiveness by tracking deaths, organ damage, and major complications.

What this could mean

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

Active substance
Intravascular ultrasound (IVUS) catheter
What this could lead to
If successful, this technique could help surgeons detect and treat organ blood-flow problems during the same surgery, potentially reducing serious complications.
What could go wrong
This is a small pilot study with only 50 participants, so results may not apply to all patients. The device is used during a complex emergency procedure, and risks include vascular injury or false readings.

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

50 people

The number who actually took part.

Started

Mar 2022

Finished

Dec 2025

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Patients diagnosed with an AAD or acute on chronic aortic dissection, with a new diagnosis of malperfusion syndrome (Malperfusion Primary Cohort), by meeting both of the following criteria: * Imaging findings indicating reduced flow to the Celiac Trunk, Superior mesenteric artery, either renal artery or either iliac artery * Clinical stigmata of end organ ischemia (abdominal pain, distended abdomen, oliguria/anuria, reduced pulses, signs of limb ischemia) correlating with imaging findings * OR o Laboratory findings suggestive of end organ ischemia (lactic acidosis, elevated LFTs, Elevated Creatinine, Rhabdomyolysis, Electrolyte abnormalities) correlating with imaging findings * Patients diagnosed with an AAD undergoing surgical repair without evidence of malperfusion syndrome preoperatively, but who develop malperfusion syndrome due to dynamic flow changes after true lumen flow is reinstituted intraoperatively as indicated by new clinical signs or new laboratory results meeting the following criteria (Malperfusion Secondary Cohort): * New Clinical signs include: Loss of femoral pulses, distended abdomen, reduced urine output, dusky/cold extremities * New Laboratory results include: Rising lactate (\>50% above baseline), Rising Creatinine, Metabolic Acidosis, Rising LFTs * Patients diagnosed with an AAD undergoing surgical repair without evidence of malperfusion syndrome preoperatively and postoperatively (No Malperfusion Cohort). Exclusion Criteria: * Subject has not been diagnosed with AAD, or acute on chronic aortic dissection * Subject is not hemodynamically stable to undergo IVUS evaluation * Subject has anatomy or pre-existing condition precluding safe use of IVUS evaluation * Subject has a pre-existing condition that may explain evidence of malperfusion (i.e. Dialysis patient with severe renal stenosis). * Subject or substitute decision maker has language barrier and no translator available at the time of obtaining informed consent to participate in the study.

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Conditions

The condition(s) this trial relates to.

Aortic Dissection syndromic disease

As listed by the trial registrant

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

Contacts and locations

Locations

  • London Health Scince Center - University Hospital

    London, Ontario, N5X0M5, Canada

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