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A simple gas flush before aortic repair might prevent strokes

NCT ID NCT07734584

Disease control Sponsor: University of Bologna 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial tests whether flushing a stent-graft with carbon dioxide before implanting it in the aorta can reduce the number of tiny air bubbles that travel to the brain during the procedure. These bubbles are a major cause of stroke and silent brain damage in patients undergoing thoracic endovascular aortic repair (TEVAR). About 90 adults with aortic tears or aneurysms will be randomly assigned to receive either standard saline flushing or a carbon dioxide flush followed by saline. The main goal is to see if the CO₂ group has fewer brain lesions detected on MRI after surgery.

What this could mean

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

Active substance
carbon dioxide flushing of the stent-graft before implantation
What this could lead to
If it works, this simple flushing step could become a standard practice to lower the risk of stroke and silent brain damage during aortic stent-graft procedures.
What could go wrong
This is a relatively small, early-stage trial, and the benefit may not be large enough to justify the extra step. The procedure itself carries inherent risks of stroke and other complications regardless of flushing.

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 90 people

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

Started

Jul 2025

Expected to finish

Jul 2028

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 years and older

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: * Age is at least 18 years * Present with type B acute aortic syndrome in the acute, subacute, or chronic phase * Thoracic and thoracoabdominal aneurysms with Crawford extent I, II, III, or IV * Written informed consent Exclusion Criteria: * Procedure performed using CO₂ angiography * Endografts without a sheath is used * Emergency endovascular treatment required * Patient has experienced a stroke or TIA within the previous six months * Proximal sealing zone is 0 or 1 * Any contraindication to DW-MRI * Pregnancy or breastfeeding

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Conditions

The condition(s) this trial relates to.

Aneurysm aortic aneurysm Flushing stroke disorder thoracic aortic aneurysm transient ischemic attack

As listed by the trial registrant

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

Thoracic and thoracoabdominal aneurysms with crawford extent I, II, III, or iv Type B acute aortic syndrome

How to take part

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

  1. The places running it

    4 sites. 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

  • A.S.S.T. Spedali Civili di Brescia

    NOT_YET_RECRUITING

    Brescia, Italy, 25123, Italy

  • Azienda Ospedaliero-Universitaria di Padova

    NOT_YET_RECRUITING

    Padova, Italy, 35128, Italy

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    RECRUITING

    Bologna, Italy, 40138, Italy

  • IRCCS Policlinico San Martino di Genova

    NOT_YET_RECRUITING

    Genova, Italy, 16132, Italy

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