Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Treatment for acute stroke with carotid artery issues

Official title: A Multi-centre, Prospective, Randomized, Open-label, Blinded Endpoint (PROBE) Controlled Trial Comparing Cervical Internal Carotid Artery Stenting to no Stenting During Thrombectomy for Tandem Occlusion Stroke

Run by Centre hospitalier de l'Université de Montréal (CHUM) · NCT04261478 · Data updated 2026-11-12

This study is testing if combining a procedure to open blocked carotid arteries with a treatment to remove blood clots can help people who have had a stroke feel better after 90 days.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment458 (estimated)
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
Academic / other
Locations1 site (Montreal, Quebec)
StatusRecruiting
StartedAugust 31, 2020
Main results expectedMay 2027
Study endsOctober 2027
Registry record updatedAugust 14, 2026
Trial IDNCT04261478 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older who have experienced an acute ischemic anterior circulation stroke with high-grade stenosis or occlusion of the internal carotid artery.

Probably not a fit

Patients with pre-existing neurological impairments or those with conditions that hinder protocol adherence may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effectiveness of carotid artery stenting combined with endovascular thrombectomy in patients suffering from acute anterior circulation strokes with concurrent high-grade stenosis or occlusion of the internal carotid artery. It is a phase III, multi-centre, randomized, open-label trial that aims to compare functional outcomes at 90 days between patients receiving stenting and those undergoing thrombectomy alone. The study will enroll 458 adult patients across 10-12 high-volume stroke centers in Canada, with a follow-up period of up to one year.

Why it matters

Potential benefit: If successful, this approach could significantly improve functional outcomes for patients suffering from acute strokes with carotid artery complications.

How similar studies have gone: While previous studies have suggested potential benefits of stenting in similar patient populations, high-quality randomized trial data are currently lacking, making this approach relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Centre Hospitalier de l'Université de Montréal
    Montreal, Quebec, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.