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MRI brain scan could prevent unnecessary stroke surgeries

NCT ID NCT07556887

Disease control Sponsor: Maastricht University Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tests a new decision-making tool called IMPROVE that uses MRI scans to detect unstable plaques in the carotid artery. The goal is to see if this method is at least as good as the current standard (which mainly looks at how narrow the artery is) for selecting which patients with a recent stroke or TIA should have surgery or stenting. About 613 participants will be randomly assigned to either the IMPROVE-based approach or usual care, and followed for several years to compare stroke rates and costs.

What this could mean

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

Active substance
IMPROVE risk model (a decision tool using MRI scans to assess stroke risk)
What this could lead to
If it works, this could help doctors decide more accurately who needs surgery to prevent a stroke, reducing strokes and unnecessary procedures.
What could go wrong
This is a mid-stage trial with 613 participants, so results may not apply to everyone. The new method might not be as effective as the standard approach, and MRI scans can be costly or unavailable.

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 613 people

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

Started

Mar 2026

Expected to finish

Aug 2031

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: * Mentally competent * 18 years or older * Recent (\<30 days) stroke (modified Rankin scale ≤3) or TIA * Ipsilateral 30-99% atheromatous stenosis at the carotid bifurcation assessed using non-invasive imaging according to NASCET criteria * Life expectancy \>5 years * Patient and stenosis are suitable for carotid revascularisation * Patient is agreeable to randomisation and willing to accept either IMPROVE-based or CAU-based selection method for carotid revascularisation Exclusion Criteria: * Cardiac source of embolism * Carotid stenosis caused by non-atherosclerotic disease e.g. dissection, fibromuscular disease or neck radiotherapy. * MRI contra-indications * Pregnancy

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Conditions

The condition(s) this trial relates to.

atherosclerosis carotid artery disorder carotid stenosis cerebral infarction ischemic stroke stroke disorder transient ischemic attack

As listed by the trial registrant

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

Atheroscleroses Atherosclerosis cerebral infarction Carotid arteriosclerosis Carotid artery stenosis symptomatic Intraplaque hemorrhage Ischemic cerebral infarction Stroke Stroke (CVA) or tia Stroke, ischemic Tia (transient ischemic attack)

How to take part

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

  1. The places running it

    10 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

  • Albert Schweitzer Ziekenhuis

    NOT_YET_RECRUITING

    Dordrecht, South Holland, 3300 AK, Netherlands

  • Amsterdam UMC

    NOT_YET_RECRUITING

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • Erasmus MC

    NOT_YET_RECRUITING

    Rotterdam, South Holland, 3000 CA, Netherlands

  • Haaglanden MC

    NOT_YET_RECRUITING

    The Hague, South Holland, 2501 CK, Netherlands

  • Isala

    NOT_YET_RECRUITING

    Zwolle, Overijssel, 8025 AB, Netherlands

  • Maastricht University

    RECRUITING

    Maastricht, Limburg, 6229 ER, Netherlands

  • Radboud UMC

    NOT_YET_RECRUITING

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Rijnstate

    NOT_YET_RECRUITING

    Arnhem, Gelderland, 6800 TA, Netherlands

  • Utrecht UMC

    NOT_YET_RECRUITING

    Utrecht, Utrecht, 3584 CX, Netherlands

  • Zuyderland

    NOT_YET_RECRUITING

    Heerlen, Limburg, 6419 PC, Netherlands

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