Treatment for acute stroke with carotid artery issues
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 458 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04261478 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with pre-existing neurological impairments or those with conditions that hinder protocol adherence may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Montreal, Quebec
- Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Alexandre Y Poppe, MD CM — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Alexandre Y Poppe, MD CM
- Email: alexandre.poppe.med@ssss.gouv.qc.ca
- Phone: 5148908000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.