Stroke, AcuteEASI-TOCNCT04261478
Endovascular Acute Stroke Intervention - Tandem OCclusion Trial
A study testing Carotid artery stenting and Antiplatelet Agents in people with Stroke, Acute and Carotid Stenosis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Patients with tandem occlusion or tandem lesion (TL), that is, stroke with an acute intracranial anterior circulation occlusion and an ipsilateral cervical ICA (c-ICA) high-grade stenosis or occlusion, constitute about 15-20% of patients undergoing endovascular thrombectomy (EVT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Carotid Stenosis, Carotid Artery Diseases
- What is being tested?
- Carotid artery stenting and Antiplatelet Agents
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteCanada
- Study dates
- 31 Aug 2020to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
Alexandre Y Poppe, MD CM, 5148908000 ext. 26268, alexandre.poppe.med@ssss.gouv.qc.ca
Imene Fahmi, MSc, 5148908000 ext. 262642, easitoc.chum@ssss.gouv.qc.ca
About this study
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
Patients with tandem occlusion or tandem lesion (TL), that is, stroke with an acute intracranial anterior circulation occlusion and an ipsilateral cervical ICA (c-ICA) high-grade stenosis or occlusion, constitute about 15-20% of patients undergoing endovascular thrombectomy (EVT).
However, the optimal treatment of acute stroke patients with TL remains uncertain, as relatively few patients with TL were included in the major randomized controlled trials of EVT and management of the c-ICA was generally not specified by protocol nor analyzed post-hoc.
Read more
Recent large multi-centre retrospective cases series suggest that acutely stented patients may have more favorable outcomes than patients treated with angioplasty alone or those with no acute ICA intervention, but high quality randomized trial data are lacking.
EASI-TOC, a phase 3, academic multi-centre, controlled trial (PROBE design) with embedded pilot phase, will seek to determine if in patients undergoing acute intracranial thrombectomy for anterior circulation stroke with concurrent ipsilateral symptomatic high-grade (≥70%) atherosclerotic stenosis or occlusion of the extracranial ICA, endovascular ICA revascularization with stenting is superior to intracranial thrombectomy alone with regards to functional outcome at 90 days. Patients will be randomized to Acute stenting or No acute stenting (1:1 allocation).
Read the detailed description
EASI-TOC is a phase III multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) controlled trial (1:1 allocation).
The trial will seek to determine if in patients undergoing acute intracranial thrombectomy for anterior circulation stroke with concurrent ipsilateral symptomatic high-grade (≥70%) atherosclerotic stenosis or occlusion of the extracranial ICA, endovascular ICA revascularization with stenting is superior to intracranial thrombectomy alone with regards to functional outcome at 90 days (measured using the Modified Rankin Scale).
EASI-TOC will be conducted at 10-12 high-volume comprehensive stroke centres in Canada.
458 male and female adult (aged ≥ 18 years) patients will be enrolled.
Patients will be randomized (1:1) to undergo acute ICA stenting during the thrombectomy procedure (either before or after intracranial thrombectomy, at the discretion of the treating physician) or to intracranial thrombectomy alone without ICA stenting. Deferred ICA intervention is allowed, if indicated. Randomization will be centralized and web-based. Stratification will be performed for use or not of IV alteplase and for enrolling site.
Patients will be treated acutely and followed up to one year.
Our primary hypothesis assumes a greater proportion of patients with 90-day mRS 0-2 in the stenting group versus the no stenting group (55% versus 40%). Assuming a minimal clinically important difference of 15 % between groups experiencing no crossover, a total of 173 patients per group would be sufficient to detect this difference, with a power of 80 % and a significance level of 5 %. Taking into account a cross-over rate of 10% (5% in either direction) and a loss to follow-up of 5 %, the total sample size will increase to 450 patients.
Primary analysis will be by Intention-to-treat. Pre-specified as-treated, sex-specific and subgroup analyses will also be performed.
Informed consent will be obtained from patients or their surrogate. Deferral of consent will be allowed if permitted by local ethics committees.
- Conditions
- Stroke, Acute, Carotid Stenosis, Carotid Artery Diseases
- Being tested
- Carotid artery stenting, Antiplatelet Agents
- Keywords
- Thrombectomy, Tandem occlusion, Carotid stenting
- Medical subject headings
- Stroke, Carotid Stenosis, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid artery stentingDevice
Also called Stenting
The type of stent should be one commonly used for ICA stenting. Balloon angioplasty before and/or after stent placement will be allowed as required. Stenting should be performed after intracranial thrombectomy unless specific technical circumstances suggest that access to the intracranial circulation requires anterograde stenting. Embolic protection devices should not be used routinely during ICA stent placement.
Antiplatelet AgentsDrug
The following antiplatelet regimen should be used: For patients having received IV thrombolysis, immediate post-procedural oral or intrarectal single antiplatelet agents, (Aspirin 325mg PO or 650mg PR). A second agent (usually Clopidogrel 300mg PO) is added after follow-up brain imaging at 12-24 hours confirms absence of significant ICH. For patients having not been treated with IV thrombolysis, dual antiplatelet therapy (Aspirin 325mg PO or 650mg PR and Clopidogrel 300-600mg PO) is given immediately post-procedure. Routine use of GPIIb/IIIa inhibitors is allowed while periprocedural IV Heparin is discouraged.
| Study group | Role | What they receive |
|---|---|---|
| Acute Stenting | Active comparator | All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be revascularized with a stent during the acute thrombectomy procedure. Receives: Device: Carotid artery stenting; Drug: Antiplatelet Agents |
| No Acute Stenting | No intervention | All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be not revascularized with a stent during the acute thrombectomy procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy outcome: proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2)
The proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days (dichotomized) The Modified Rankin Score (mRS) is a 7 point disability scale with possible scores ranging from 0 to 6, with 0 indicating no disability and 6 indicating death.
Measured: 90 days ± 14 days
Secondary outcomes (12)
Clinical efficacy outcome: Proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days (dichotomized) according to sex
Proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days (dichotomized) according to sex
Measured: 90 days ± 14 days
Clinical efficacy outcome: Ordinal logistic regression for functional improvement on the Modified Rankin Scale (mRS) score (shift analysis)
Ordinal logistic regression for functional improvement by at least one mRS category at 90 days ("shift analysis") The Modified Rankin Score (mRS) is a 7 point disability scale with possible scores ranging from 0 to 6, with 0 indicating no disability and 6 indicating death.
Measured: 90 days ± 14 days
Clinical efficacy outcome: Median National Institutes of Health Stroke Scale (NIHSS) score
Median NIHSS score at 24 hours after stroke The NIHSS is a 15 item neurologic examination that provides a quantitative measure of stroke-related neurologic deficit. (Scale from 0 to 42, with higher scores indicating a more severe neurologic deficit)
Measured: 24 hours ± 8 hours
Clinical efficacy outcome: Median National Institutes of Health Stroke Scale (NIHSS) score
Median NIHSS score at 90 days after stroke The NIHSS is a 15 item neurologic examination that provides a quantitative measure of stroke-related neurologic deficit. (Scale from 0 to 42, with higher scores indicating a more severe neurologic deficit)
Measured: 90 days ± 14 days
Clinical efficacy outcome: Median Modified Rankin Scale (mRS) score
Median mRS at 90 days after stroke The Modified Rankin Score (mRS) is a 7 point disability scale with possible scores ranging from 0 to 6, with 0 indicating no disability and 6 indicating death.
Measured: 90 days ± 14 days
Clinical efficacy outcome: Rate of clinically confirmed recurrent ipsilateral stroke or retinal ischemia
Rate of clinically confirmed recurrent ipsilateral stroke or retinal ischemia within 90 days (imaging as clinically indicated) A structured telephone questionnaire for verifying stroke-free status will be used and relevant imaging reviewed
Measured: 90 days ± 14 days
Radiological efficacy outcome: Proportion of patients with complete or near-complete recanalization
Proportion of patients with complete or near-complete recanalization (mTICI 2b/3) at the end of the endovascular procedure.
mTICI score (0,1,2,2a,2b,3) : Grade 0 : no perfusion Grade 1 : penetration with minimal perfusion Grade 2 : partial perfusion Grade 2a : partial filling of less than 1/2 of the vascular territory Grade 2b : partial filling 50-99% of the vascular territory Grade 3 : complete perfusion Independent imaging core laboratory
Measured: End of endovascular procedure
Radiological efficacy outcome: Proportion of patients with ICA thrombosis (with or without stent)
Proportion of patients with ICA thrombosis (with or without stent) within 90 days after stroke stent patency be evaluated by angiography at the end of the EVT procedure. Furthermore, follow-up carotid vascular imaging will be required between 1 and 90 days following stent placement in the context of usual care. Any non-invasive imaging modality will be allowed, with carotid doppler or CTA strongly recommended.
Measured: 90 days ± 14 days
Clinical efficacy outcome: Median Montreal Cognitive Assessment (MoCA) score
Median Montreal Cognitive Assessment (MoCA) score at 90 days after stroke The MoCA is a 30-point screening tool for cognitive dysfunction (score from 0 to 30 with lower scores indicating greater cognitive impairment). The test assesses 8 domains of cognitive functioning: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Measured: 90 days ± 14 days
Clinical efficacy outcome: Rate of any recurrent stroke or retinal ischemia
Rate of any recurrent stroke or retinal ischemia at 12 months after stroke A structured telephone questionnaire for verifying stroke-free status will be used
Measured: 1 year ± 60 days
Clinical efficacy outcome: Proportion of patients achieving a favorable modified Rankin scale (mRS) score
Proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 12 months after stroke The Modified Rankin Score (mRS) is a 7 point disability scale with possible scores ranging from 0 to 6, with 0 indicating no disability and 6 indicating death.
Measured: 1 year ± 60 days
Clinical efficacy outcome: Quality of Life
Quality of life as measured by the EQ-5D-5L tool, completed by the patient or, if impossible, by their proxy.
Measured: 90 days +/- 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start31 Aug 2020
- Primary completionMay 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) controlled trial (1:1 allocation).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 458 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Laval University, Queen's University, University of Ottawa, McMaster University, University of Calgary, University of British Columbia, Dalhousie University, Health Sciences North Research Institute, University of Toronto, University of Alberta, Canadian Stroke Consortium (CSC), University of Manitoba, Université de Sherbrooke, Canadian Institutes of Health Research (CIHR), Brain Canada, Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Alexandre Y Poppe, MD CM, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261478
- Sponsor's protocol ID
- MP-02-2020-8614
- Acronym
- EASI-TOC
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2020
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Upon completion of the EASI-TOC Trial, a public use database will be prepared by stripping any and all personal identifiers. The public use database, consisting of several data files, should contain: (1) baseline and demographic characteristics; (2) outcomes assessments; (3) imaging data; (4) serious adverse events. These data files will be made available to researchers with validated requests only after all major manuscripts (including secondary analysis papers) of the Trial are accepted for publication in peer-reviewed journals.
Publications
Mendes GN, Jacquin G, Iancu D, Roy D, Yu M, Bodson-Clermont P, Fahmi I, Ahmed SU, Almekhlafi M, Buck B, Camden MC, Catanese L, Diestro D, Fahed R, Field TS, Guest W, Hawkes C, Hill MD, Kelly ME, Kim CN, Legault C, Milot G, Moreau F, Muccilli A, Rempel J, Shamy M, Singh RJ, Van Adel BA, Volders D, Shankar J, Singh N, Stapf C, Poppe AY. Endovascular Acute Stroke Intervention-Tandem Occlusion (EASI-TOC) study: protocol and rationale. Eur Stroke J. 2026 Mar 1;11(4):aakag036. doi: 10.1093/esj/aakag036.
PubMed 42024493
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04261478
- Acronym / sponsor ID
- EASI-TOC / MP-02-2020-8614
- Conditions
- Stroke, Acute, Carotid Stenosis, Carotid Artery Diseases
- Keywords
- Thrombectomy, Tandem occlusion, Carotid stenting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 458 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- McGill University, Laval University, Queen's University, University of Ottawa, McMaster University, University of Calgary, University of British Columbia, Dalhousie University, Health Sciences North Research Institute, University of Toronto, University of Alberta, Canadian Stroke Consortium (CSC), University of Manitoba, Université de Sherbrooke, Canadian Institutes of Health Research (CIHR), Brain Canada, Heart and Stroke Foundation of Canada
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with tandem occlusion or tandem lesion (TL), that is, stroke with an acute intracranial anterior circulation occlusion and an ipsilateral cervical ICA (c-ICA) high-grade stenosis or occlusion, constitute about 15-20% of patients undergoing endovascular thrombectomy (EVT).
However, the optimal treatment of acute stroke patients with TL remains uncertain, as relatively few patients with TL were included in the major randomized controlled trials of EVT and management of the c-ICA was generally not specified by protocol nor analyzed post-hoc.
Recent large multi-centre retrospective cases series suggest that acutely stented patients may have more favorable outcomes than patients treated with angioplasty alone or those with no acute ICA intervention, but high quality randomized trial data are lacking.
EASI-TOC, a phase 3, academic multi-centre, controlled trial (PROBE design) with embedded pilot phase, will seek to determine if in patients undergoing acute intracranial thrombectomy for anterior circulation stroke with concurrent ipsilateral symptomatic high-grade (≥70%) atherosclerotic stenosis or occlusion of the extracranial ICA, endovascular ICA revascularization with stenting is superior to intracranial thrombectomy alone with regards to functional outcome at 90 days. Patients will be randomized to Acute stenting or No acute stenting (1:1 allocation).
Detailed description
EASI-TOC is a phase III multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) controlled trial (1:1 allocation).
The trial will seek to determine if in patients undergoing acute intracranial thrombectomy for anterior circulation stroke with concurrent ipsilateral symptomatic high-grade (≥70%) atherosclerotic stenosis or occlusion of the extracranial ICA, endovascular ICA revascularization with stenting is superior to intracranial thrombectomy alone with regards to functional outcome at 90 days (measured using the Modified Rankin Scale).
EASI-TOC will be conducted at 10-12 high-volume comprehensive stroke centres in Canada.
458 male and female adult (aged ≥ 18 years) patients will be enrolled.
Patients will be randomized (1:1) to undergo acute ICA stenting during the thrombectomy procedure (either before or after intracranial thrombectomy, at the discretion of the treating physician) or to intracranial thrombectomy alone without ICA stenting. Deferred ICA intervention is allowed, if indicated. Randomization will be centralized and web-based. Stratification will be performed for use or not of IV alteplase and for enrolling site.
Patients will be treated acutely and followed up to one year.
Our primary hypothesis assumes a greater proportion of patients with 90-day mRS 0-2 in the stenting group versus the no stenting group (55% versus 40%). Assuming a minimal clinically important difference of 15 % between groups experiencing no crossover, a total of 173 patients per group would be sufficient to detect this difference, with a power of 80 % and a significance level of 5 %. Taking into account a cross-over rate of 10% (5% in either direction) and a loss to follow-up of 5 %, the total sample size will increase to 450 patients.
Primary analysis will be by Intention-to-treat. Pre-specified as-treated, sex-specific and subgroup analyses will also be performed.
Informed consent will be obtained from patients or their surrogate. Deferral of consent will be allowed if permitted by local ethics committees.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A multi-centre, prospective, randomized, open-label, blinded endpoint (PROBE) controlled trial (1:1 allocation).
| Arm | Type | Receives |
|---|---|---|
| Acute Stenting | Active comparator | Device: Carotid artery stenting, Drug: Antiplatelet AgentsAll patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be revascularized with a stent during the acute thrombectomy procedure. |
| No Acute Stenting | No intervention | –All patients in this arm will receive standard of care with regards to intracranial thrombectomy and use of intravenous thrombolysis. In this arm, the cervical carotid artery stenosis will be not revascularized with a stent during the acute thrombectomy procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Acute ischemic anterior circulation stroke eligible for endovascular therapy according to local guidelines, with or without prior intravenous thrombolysis:
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid artery stentingAlso: StentingThe type of stent should be one commonly used for ICA stenting. Balloon angioplasty before and/or after stent placement will be allowed as required. Stenting should be performed after intracranial thrombectomy unless specific technical circumstances suggest that access to the intracranial circulation requires anterograde stenting. Embolic protection devices should not be used routinely during ICA stent placement. | Device | Acute Stenting |
| Antiplatelet AgentsThe following antiplatelet regimen should be used: For patients having received IV thrombolysis, immediate post-procedural oral or intrarectal single antiplatelet agents, (Aspirin 325mg PO or 650mg PR). A second agent (usually Clopidogrel 300mg PO) is added after follow-up brain imaging at 12-24 hours confirms absence of significant ICH. For patients having not been treated with IV thrombolysis, dual antiplatelet therapy (Aspirin 325mg PO or 650mg PR and Clopidogrel 300-600mg PO) is given immediately post-procedure. Routine use of GPIIb/IIIa inhibitors is allowed while periprocedural IV Heparin is discouraged. | Drug | Acute Stenting |
Primary outcome
Clinical efficacy outcome: proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2)
Time frame: 90 days ± 14 days
The proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days (dichotomized) The Modified Rankin Score (mRS) is a 7 point disability scale with possible scores ranging from 0 to 6, with 0 indicating no disability and 6 indicating death.
12 secondary outcomes
Clinical efficacy outcome: Proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) at 90 days (dichotomized) according to sex
Time frame: 90 days ± 14 days
Clinical efficacy outcome: Ordinal logistic regression for functional improvement on the Modified Rankin Scale (mRS) score (shift analysis)
Time frame: 90 days ± 14 days
Clinical efficacy outcome: Median National Institutes of Health Stroke Scale (NIHSS) score
Time frame: 24 hours ± 8 hours
Clinical efficacy outcome: Median National Institutes of Health Stroke Scale (NIHSS) score
Time frame: 90 days ± 14 days
Clinical efficacy outcome: Median Modified Rankin Scale (mRS) score
Time frame: 90 days ± 14 days
Clinical efficacy outcome: Rate of clinically confirmed recurrent ipsilateral stroke or retinal ischemia
Time frame: 90 days ± 14 days
Radiological efficacy outcome: Proportion of patients with complete or near-complete recanalization
Time frame: End of endovascular procedure
Radiological efficacy outcome: Proportion of patients with ICA thrombosis (with or without stent)
Time frame: 90 days ± 14 days
Clinical efficacy outcome: Median Montreal Cognitive Assessment (MoCA) score
Time frame: 90 days ± 14 days
Clinical efficacy outcome: Rate of any recurrent stroke or retinal ischemia
Time frame: 1 year ± 60 days
Clinical efficacy outcome: Proportion of patients achieving a favorable modified Rankin scale (mRS) score
Time frame: 1 year ± 60 days
Clinical efficacy outcome: Quality of Life
Time frame: 90 days +/- 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Derived from this study: PubMed 42024493Mendes GN, Jacquin G, Iancu D, Roy D, Yu M, Bodson-Clermont P, Fahmi I, Ahmed SU, Almekhlafi M, Buck B, Camden MC, Catanese L, Diestro D, Fahed R, Field TS, Guest W, Hawkes C, Hill MD, Kelly ME, Kim CN, Legault C, Milot G, Moreau F, Muccilli A, Rempel J, Shamy M, Singh RJ, Van Adel BA, Volders D, Shankar J, Singh N, Stapf C, Poppe AY. Endovascular Acute Stroke Intervention-Tandem Occlusion (EASI-TOC) study: protocol and rationale. Eur Stroke J. 2026 Mar 1;11(4):aakag036. doi: 10.1093/esj/aakag036.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Upon completion of the EASI-TOC Trial, a public use database will be prepared by stripping any and all personal identifiers. The public use database, consisting of several data files, should contain: (1) baseline and demographic characteristics; (2) outcomes assessments; (3) imaging data; (4) serious adverse events. These data files will be made available to researchers with validated requests only after all major manuscripts (including secondary analysis papers) of the Trial are accepted for publication in peer-reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandre Y Poppe, MD CM principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotid artery stenting and Antiplatelet Agents in people with Stroke, Acute and Carotid Stenosis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Y Poppe, MD CM (5148908000 ext. 26260, alexandre.poppe.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy outcome: proportion of patients achieving a favorable modified Rankin scale score (mRS 0-2) (time frame: 90 days ± 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04261478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.