Stroke, AcuteEASINCT02157532
Endovascular Acute Stroke Intervention Trial - the EASI Trial
A study testing mechanical thrombectomy and Best standard treatment in people with Stroke, Acute, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
Trial summary
Stroke constitutes the primary cause of acquired disability in adults and the second cause of dementia following Alzheimer disease. It has been shown that patients with a moderate to severe clinical score have occlusion of brain large vessels, resulting in a worse clinical outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- mechanical thrombectomy and Best standard treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2013to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age greater than or equal to 18
- NIHSS greater than or equal to 8
- onset of symptoms is less than 5 hours OR symptom/imaging mismatch
- suspected occlusion of the M1 or M2 segment of the MCA, supraclinoid ICA, or basilar trunk.
Who cannot join
- established infarction of the target symptomatic territory
- co-morbid diseases which suggest a poor 90 day outcome irrespective of management
- radiologic evidence of hemorrhagic transformation of the infarcted territory
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Alberta Hospital
Edmonton, Alberta
Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
Montreal, Quebec, H2L 4M1
About this study
Official title: Intra-arterial Thrombectomy as an Acute Treatment Intervention for Stoke: the Endovascular Acute Stoke Intervention (EASI) Trial
Stroke constitutes the primary cause of acquired disability in adults and the second cause of dementia following Alzheimer disease. It has been shown that patients with a moderate to severe clinical score have occlusion of brain large vessels, resulting in a worse clinical outcome. Many studies have demonstrated that early recanalization after IV rtPA is more restricted, the larger and more proximal the artery. Several systems for mechanical intracranial arterial thrombectomy of large trunks have recently been proposed and are now available. Potential advantages of these mechanical systems on chemical thrombolysis are speed (a few minutes versus 1 hour) and absence of thrombolytic injection.
The objective of the EASI trial is thus to:
Read more
- To validate intra-arterial thrombectomy use during the acute phase of cerebral stroke in patients treated with IV thrombolysis or in patients for whom thrombolysis is contra-indicated.
- To determine whether a combined approach, standard treatment plus thrombectomy, is superior to standard treatment alone within 5 h of the appearance of symptoms, in patients with occlusion of proximal cerebral arteries following moderate to severe stroke (NIHSS larger than or equal to 8), evaluated at 3 months.
The design is a randomized, controlled multicentric trial, with a parallel comparison between standard and combined (standard plus thrombectomy) treatment.
480 patients fulfilling eligibility criteria will be sufficient to demonstrate the primary hypothesis of a 15% difference in number of subjects with a favorable mRS (less than or equal to 2) at 3 months, with the assumption of a 25% efficacy for IV thrombolytic treatment at 3 months.
IV thrombolysis is carried out according to standard practice. Mechanical thrombectomy is carried out with already approved devices, according to the manufacturer's instructions, following a diagnostic cerebral angiography.
The primary efficacy endpoint is clinical: favorable mRS (less than or equal to 2) at 3 months.
The primary safety endpoint is rate of death at 3 months and rate of symptomatic hemorrhage at 24 hours.
If the primary hypothesis is validated, expected benefits of this study is a higher rate of autonomy for stroke patients with all the attendant consequences: reduction in hospital stays, and a faster return to the activities of daily life.
Read the detailed description
Background Stroke constitutes the primary cause of acquired disability in adults and the second cause of dementia following Alzheimer disease. The burden of disease may be substantial since 25% of the victims of stroke are younger than 65 years. Standard treatment is IV rtPA thrombolysis, within 3-4.5 hours of first signs. It has been shown that patients with a moderate to severe clinical score (NIHSS more than 10) have occlusion of proximal large vessels, resulting in a more adverse clinical outcome. Many studies have demonstrated that early recanalization after IV rtPA is more restricted, the larger and more proximal the artery. Recanalization of large arteries occurs more frequently and earlier (leading to better prognosis) with arterial than with venous access. Biochemical arterial treatment appears thus of greater efficacy in terms of recanalization of large vessels, but more inconvenient with respect to setup delays. Several systems for mechanical intracranial arterial thrombectomy of large trunks have recently been proposed and are now available. Results of short case series and prospective multicentric non randomized studies appear favorable. The thrombus obstructing the artery is reached by endovascular means and mechanically removed with the result that orthograde blood flow is re-established in the cerebral territory involved in the ischemia. Potential advantages of these mechanical systems on chemical thrombolysis are speed (a few minutes versus 1 hour) and absence of thrombolytic injection. Mechanical thrombolysis should thus lead to better results than injection of an arterial thrombolytic agent, as well as increase the time window for treatment. In addition, hemorrhagic complications should be reduced.
Objectives
In situations where IV rtPA thrombolysis is not optimal, that is in presumed embolic occlusions of large intracranial arterial trunks (terminal carotid, initial segment of the MCA, distal third of the basilar trunk) with a moderate to severe clinical state (NIHSS greater or equal to 8) and in situations when IV rtPA may be contra-indicated:
- To validate intra-arterial thrombectomy use during the acute phase of cerebral stroke in patients treated with IV thrombolysis or in patients for whom thrombolysis is contra-indicated.
- To determine whether a combined approach, standard treatment plus thrombectomy, is superior to standard treatment alone within 5 h of the appearance of symptoms, in patients with occlusion of proximal cerebral arteries following moderate to severe stroke (greater or equal to 8), evaluated at 3 months.
Design EASI is a randomized, controlled multicentric trial, with a parallel comparison between standard and combined (standard plus thrombectomy) treatment. All adults presenting less than 5 hours after the beginning of symptoms with an NIHSS greater or equal to 8 discordant with imaging data are eligible. Occlusion site, when available, includes intracranial carotid artery, M1 segment of middle cerebral and basilar artery.
480 patients fulfilling eligibility criteria will be sufficient to demonstrate the primary hypothesis of a 15% difference in number of subjects with a favorable mRS (greater than 2) at 3 months, with the assumption of a 25% efficacy (mRS less or equal to 2) for IV thrombolytic treatment at 3 months.
Randomization may take place any time following admission, including during IV thrombolysis. The choice of early randomization, without knowledge of the clinical or angiographic results of IV thrombolysis fulfils several objectives: allow timely delivery of a proven treatment; prevent unnecessary exposure to angiography risks; set up thrombectomy as fast as possible for a maximal efficacy.
IV thrombolysis is carried out according to standard practice. Mechanical thrombectomy is carried out with already approved devices, according to the manufacturer's instructions, following a diagnostic cerebral angiography.
Follow-up includes brain imaging and the mRS at 3 months.
Endpoint measures include:
- Clinical endpoints as measured by the neurologist, and include the NIHSS at baseline and the mRS at 3 months.
- Safety data: complications, death at 3 months, hemorrhage according to 24 hours CT scan.
The primary efficacy endpoint is clinical: favorable mRS (less than or equal to 2) at 3 months.
The primary safety endpoint is rate of death at 3 months and rate of symptomatic hemorrhage at 24 hours.
Secondary efficacy endpoints include:
- Comparison of ASPECTS score between baseline and 24 hours CT scans
- In thrombectomy group, blood flow in treated territory as measured by a TICI reperfusion score of 2 or 3 at end of treatment.
Secondary safety endpoints include
- Rate of hemorrhage on 24 hours CT scan
- Frequency and severity of complications of standard treatment
- Frequency and severity of arterial complications in thrombectomy group
- Frequency and severity of complications at puncture site in thrombectomy group
- Conditions
- Stroke, Acute
- Being tested
- mechanical thrombectomy, Best standard treatment
- Keywords
- Severe stroke, IV tPA, mechanical thrombectomy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical thrombectomyProcedure or surgery
Mechanical thrombectomy using any already approved stent-retriever device
Best standard treatmentDrug
Also called Medical management
Intravenous r-tPA infusion or any other medical management option
| Study group | Role | What they receive |
|---|---|---|
| Best standard treatment | Active comparator | intravenous r-tPA or any other medical management Receives: Drug: Best standard treatment |
| Mechanical thrombectomy | Active comparator | Endovascular mechanical thrombectomy with stent-retrievers Receives: Procedure: mechanical thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical (efficacy): favorable modified Rankin Score (less than or equal to 2)
The efficacy of mechanical thrombectomy compared to standard stroke treatment will be evaluated using the modified Rankin scale score at 3 months. This measure includes the rate of death within 3 months
Measured: 3 months
Rate of symptomatic intracranial hemorrhage
the incidence of symptomatic hemorrhage on non-contrast CT at 24 hours will be recorded
Measured: 24 hours
Secondary outcomes (4)
Infarct evolution
the evolution of the infarct on CT will be carried out according to a semi-quantitative evaluation using the ASPECT score between the pre-treatment CT and the 24 hour cross-sectional imaging study
Measured: 24 hours
Angiographic outcome in patients allocated to mechanical thrombectomy
In patients allocated to the mechanical thrombectomy arm, the occlusion state of the target vessel will be assessed at the end of the intervention according to the TICI scale
Measured: 2 hours
Frequency and Severity of complications
All Adverse Events
Measured: 3 months
Rate of intracranial hemorrhage
The incidence of hemorrhage on non-contrast CT at 24 hours will be recorded
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2025 (estimated)
- Study completionJan 2026 (estimated)
Why it stopped: Sites are not recruiting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Raymond, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)Serge Bracard, MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157532
- Sponsor's protocol ID
- CE 12.224
- Acronym
- EASI
- Status last verified
- Sep 2024
- First submitted
- 2 Jun 2014
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Poppe AY, Jacquin G, Stapf C, Daneault N, Deschaintre Y, Gioia LC, Odier C, Labrie M, Nehme A, Nico L, Roy D, Weill A, Raymond J. A randomized pilot study of patients with tandem carotid lesions undergoing thrombectomy. J Neuroradiol. 2020 Nov;47(6):416-420. doi: 10.1016/j.neurad.2019.08.003. Epub 2019 Sep 26.
PubMed 31563589Khoury NN, Darsaut TE, Ghostine J, Deschaintre Y, Daneault N, Durocher A, Lanthier S, Poppe AY, Odier C, Lebrun LH, Guilbert F, Gentric JC, Batista A, Weill A, Roy D, Bracard S, Raymond J; EASI trial collaborators. Endovascular thrombectomy and medical therapy versus medical therapy alone in acute stroke: A randomized care trial. J Neuroradiol. 2017 Jun;44(3):198-202. doi: 10.1016/j.neurad.2017.01.126. Epub 2017 Feb 24.
PubMed 28238522
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-arterial Thrombectomy as an Acute Treatment Intervention for Stoke: the Endovascular Acute Stoke Intervention (EASI) Trial
- ClinicalTrials.gov ID
- NCT02157532
- Acronym / sponsor ID
- EASI / CE 12.224
- Conditions
- Stroke, Acute
- Keywords
- Severe stroke, IV tPA, mechanical thrombectomy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sites are not recruiting.
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 6 Jun 2014 (estimated)
- 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.
Stroke constitutes the primary cause of acquired disability in adults and the second cause of dementia following Alzheimer disease. It has been shown that patients with a moderate to severe clinical score have occlusion of brain large vessels, resulting in a worse clinical outcome. Many studies have demonstrated that early recanalization after IV rtPA is more restricted, the larger and more proximal the artery. Several systems for mechanical intracranial arterial thrombectomy of large trunks have recently been proposed and are now available. Potential advantages of these mechanical systems on chemical thrombolysis are speed (a few minutes versus 1 hour) and absence of thrombolytic injection.
The objective of the EASI trial is thus to:
- To validate intra-arterial thrombectomy use during the acute phase of cerebral stroke in patients treated with IV thrombolysis or in patients for whom thrombolysis is contra-indicated.
- To determine whether a combined approach, standard treatment plus thrombectomy, is superior to standard treatment alone within 5 h of the appearance of symptoms, in patients with occlusion of proximal cerebral arteries following moderate to severe stroke (NIHSS larger than or equal to 8), evaluated at 3 months.
The design is a randomized, controlled multicentric trial, with a parallel comparison between standard and combined (standard plus thrombectomy) treatment.
480 patients fulfilling eligibility criteria will be sufficient to demonstrate the primary hypothesis of a 15% difference in number of subjects with a favorable mRS (less than or equal to 2) at 3 months, with the assumption of a 25% efficacy for IV thrombolytic treatment at 3 months.
IV thrombolysis is carried out according to standard practice. Mechanical thrombectomy is carried out with already approved devices, according to the manufacturer's instructions, following a diagnostic cerebral angiography.
The primary efficacy endpoint is clinical: favorable mRS (less than or equal to 2) at 3 months.
The primary safety endpoint is rate of death at 3 months and rate of symptomatic hemorrhage at 24 hours.
If the primary hypothesis is validated, expected benefits of this study is a higher rate of autonomy for stroke patients with all the attendant consequences: reduction in hospital stays, and a faster return to the activities of daily life.
Detailed description
Background Stroke constitutes the primary cause of acquired disability in adults and the second cause of dementia following Alzheimer disease. The burden of disease may be substantial since 25% of the victims of stroke are younger than 65 years. Standard treatment is IV rtPA thrombolysis, within 3-4.5 hours of first signs. It has been shown that patients with a moderate to severe clinical score (NIHSS more than 10) have occlusion of proximal large vessels, resulting in a more adverse clinical outcome. Many studies have demonstrated that early recanalization after IV rtPA is more restricted, the larger and more proximal the artery. Recanalization of large arteries occurs more frequently and earlier (leading to better prognosis) with arterial than with venous access. Biochemical arterial treatment appears thus of greater efficacy in terms of recanalization of large vessels, but more inconvenient with respect to setup delays. Several systems for mechanical intracranial arterial thrombectomy of large trunks have recently been proposed and are now available. Results of short case series and prospective multicentric non randomized studies appear favorable. The thrombus obstructing the artery is reached by endovascular means and mechanically removed with the result that orthograde blood flow is re-established in the cerebral territory involved in the ischemia. Potential advantages of these mechanical systems on chemical thrombolysis are speed (a few minutes versus 1 hour) and absence of thrombolytic injection. Mechanical thrombolysis should thus lead to better results than injection of an arterial thrombolytic agent, as well as increase the time window for treatment. In addition, hemorrhagic complications should be reduced.
Objectives
In situations where IV rtPA thrombolysis is not optimal, that is in presumed embolic occlusions of large intracranial arterial trunks (terminal carotid, initial segment of the MCA, distal third of the basilar trunk) with a moderate to severe clinical state (NIHSS greater or equal to 8) and in situations when IV rtPA may be contra-indicated:
- To validate intra-arterial thrombectomy use during the acute phase of cerebral stroke in patients treated with IV thrombolysis or in patients for whom thrombolysis is contra-indicated.
- To determine whether a combined approach, standard treatment plus thrombectomy, is superior to standard treatment alone within 5 h of the appearance of symptoms, in patients with occlusion of proximal cerebral arteries following moderate to severe stroke (greater or equal to 8), evaluated at 3 months.
Design EASI is a randomized, controlled multicentric trial, with a parallel comparison between standard and combined (standard plus thrombectomy) treatment. All adults presenting less than 5 hours after the beginning of symptoms with an NIHSS greater or equal to 8 discordant with imaging data are eligible. Occlusion site, when available, includes intracranial carotid artery, M1 segment of middle cerebral and basilar artery.
480 patients fulfilling eligibility criteria will be sufficient to demonstrate the primary hypothesis of a 15% difference in number of subjects with a favorable mRS (greater than 2) at 3 months, with the assumption of a 25% efficacy (mRS less or equal to 2) for IV thrombolytic treatment at 3 months.
Randomization may take place any time following admission, including during IV thrombolysis. The choice of early randomization, without knowledge of the clinical or angiographic results of IV thrombolysis fulfils several objectives: allow timely delivery of a proven treatment; prevent unnecessary exposure to angiography risks; set up thrombectomy as fast as possible for a maximal efficacy.
IV thrombolysis is carried out according to standard practice. Mechanical thrombectomy is carried out with already approved devices, according to the manufacturer's instructions, following a diagnostic cerebral angiography.
Follow-up includes brain imaging and the mRS at 3 months.
Endpoint measures include:
- Clinical endpoints as measured by the neurologist, and include the NIHSS at baseline and the mRS at 3 months.
- Safety data: complications, death at 3 months, hemorrhage according to 24 hours CT scan.
The primary efficacy endpoint is clinical: favorable mRS (less than or equal to 2) at 3 months.
The primary safety endpoint is rate of death at 3 months and rate of symptomatic hemorrhage at 24 hours.
Secondary efficacy endpoints include:
- Comparison of ASPECTS score between baseline and 24 hours CT scans
- In thrombectomy group, blood flow in treated territory as measured by a TICI reperfusion score of 2 or 3 at end of treatment.
Secondary safety endpoints include
- Rate of hemorrhage on 24 hours CT scan
- Frequency and severity of complications of standard treatment
- Frequency and severity of arterial complications in thrombectomy group
- Frequency and severity of complications at puncture site in thrombectomy group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best standard treatment | Active comparator | Drug: Best standard treatmentintravenous r-tPA or any other medical management |
| Mechanical thrombectomy | Active comparator | Procedure: mechanical thrombectomyEndovascular mechanical thrombectomy with stent-retrievers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than or equal to 18
- NIHSS greater than or equal to 8
- onset of symptoms is less than 5 hours OR symptom/imaging mismatch
- suspected occlusion of the M1 or M2 segment of the MCA, supraclinoid ICA, or basilar trunk.
Key exclusion criteria (3 listed)
- established infarction of the target symptomatic territory
- co-morbid diseases which suggest a poor 90 day outcome irrespective of management
- radiologic evidence of hemorrhagic transformation of the infarcted territory
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 |
|---|---|---|
| mechanical thrombectomyMechanical thrombectomy using any already approved stent-retriever device | Procedure or surgery | Mechanical thrombectomy |
| Best standard treatmentAlso: Medical managementIntravenous r-tPA infusion or any other medical management option | Drug | Best standard treatment |
Primary outcome
clinical (efficacy): favorable modified Rankin Score (less than or equal to 2)
Time frame: 3 months
The efficacy of mechanical thrombectomy compared to standard stroke treatment will be evaluated using the modified Rankin scale score at 3 months. This measure includes the rate of death within 3 months
Rate of symptomatic intracranial hemorrhage
Time frame: 24 hours
the incidence of symptomatic hemorrhage on non-contrast CT at 24 hours will be recorded
4 secondary outcomes
Infarct evolution
Time frame: 24 hours
Angiographic outcome in patients allocated to mechanical thrombectomy
Time frame: 2 hours
Frequency and Severity of complications
Time frame: 3 months
Rate of intracranial hemorrhage
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 31563589Poppe AY, Jacquin G, Stapf C, Daneault N, Deschaintre Y, Gioia LC, Odier C, Labrie M, Nehme A, Nico L, Roy D, Weill A, Raymond J. A randomized pilot study of patients with tandem carotid lesions undergoing thrombectomy. J Neuroradiol. 2020 Nov;47(6):416-420. doi: 10.1016/j.neurad.2019.08.003. Epub 2019 Sep 26.
- Derived from this study: PubMed 28238522Khoury NN, Darsaut TE, Ghostine J, Deschaintre Y, Daneault N, Durocher A, Lanthier S, Poppe AY, Odier C, Lebrun LH, Guilbert F, Gentric JC, Batista A, Weill A, Roy D, Bracard S, Raymond J; EASI trial collaborators. Endovascular thrombectomy and medical therapy versus medical therapy alone in acute stroke: A randomized care trial. J Neuroradiol. 2017 Jun;44(3):198-202. doi: 10.1016/j.neurad.2017.01.126. Epub 2017 Feb 24.
Related trials for Stroke, Acute
Not yet recruitingPhase 3
INTRA-ARTERIAL MeVO TREATMENT (IMP-ACT) Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
Stroke, Acute Ischemic, Medium Vessel Occlusion
Recruiting
Role of Hypothermia in Endovascular Stroke Thrombectomy
Stroke, Acute Ischemic
RecruitingPhase 3
Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Therapy -2
Acute Ischemic Stroke
RecruitingObservational study
FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions
Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion
Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
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. This study is not recruiting at the moment.
Jean Raymond, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Serge Bracard, MD principal investigator
Central Hospital, Nancy, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical thrombectomy and Best standard treatment in people with Stroke, Acute, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites 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 4 inclusion and 3 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: paused, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical (efficacy): favorable modified Rankin Score (less than or equal to 2) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT02157532, which also lists 2 linked publications.
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 19 Sep 2024; AzTrials last refreshed its copy on 31 Oct 2026.