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Could a stent double the chance of a good recovery after severe stroke?

NCT ID NCT04261478

Disease control Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This trial tests whether placing a stent in a narrowed or blocked neck artery during emergency stroke treatment helps people recover better than just removing the clot in the brain. About 15-20% of severe strokes involve both a brain clot and a neck artery blockage. The study will compare two groups: one receiving standard clot removal plus a neck artery stent, and the other receiving only clot removal. The main goal is to see if more people achieve a good functional outcome (able to live independently) 90 days after the stroke.

What this could mean

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

Active substance
Carotid artery stenting (a small mesh tube placed in the neck artery to keep it open) plus antiplatelet medication
What this could lead to
If stenting proves better, it could become the standard add-on treatment during clot removal for these severe strokes, potentially improving recovery and reducing disability.
What could go wrong
This is a randomized trial, but stenting during an acute stroke carries risks like bleeding, vessel injury, or stent blockage. The benefit over not stenting is not yet proven, and results may not apply to all patients.

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 458 people

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

Started

Aug 2020

Expected to finish

Oct 2027

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: * Acute ischemic anterior circulation stroke eligible for endovascular therapy according to local guidelines, with or without prior intravenous thrombolysis: * Occlusion of the carotid terminus, M1 or M2 segments of the middle cerebral artery (MCA) * A neurological deficit judged to be disabling by the patient and/or treating physician * Any acute imaging judged by the treating physician to demonstrate salvageable brain tissue possibly amenable to EVT * Groin puncture within 24-hours of onset or last known normal * Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion of presumed atherosclerotic etiology on initial non-invasive vascular imaging * Informed consent from patient or surrogate or deferral of consent, according to local ethics policies Exclusion Criteria: * Pre-existing neurological impairment (modified Rankin score ≥3) * Any underlying disease or condition making protocol adherence and/or 3-month follow-up unlikely * Any known contra-indication to EVT, angioplasty/stenting, or antiplatelet therapy * Tandem ipsilateral high-grade (≥70%) cervical internal carotid artery (ICA) stenosis or occlusion NOT confirmed on conventional angiography * Ipsilateral ICA stenosis or occlusion attributable to clinically or radiologically confirmed arterial dissection * Isolated cervical carotid occlusion without intracranial occlusion * Pregnancy

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Conditions

The condition(s) this trial relates to.

carotid artery disorder carotid stenosis stroke disorder

As listed by the trial registrant

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

Carotid artery diseases Carotid stenosis Stroke, acute

How to take part

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

  1. The places running it

    1 site. 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

  • Centre Hospitalier de l'Université de Montréal

    RECRUITING

    Montreal, Quebec, H2X 0C1, Canada

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