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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02142283
Registration number
NCT02142283
Ethics application status
Date submitted
15/05/2014
Date registered
20/05/2014
Date last updated
20/07/2018
Titles & IDs
Public title
Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention With Trevo
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Scientific title
Diffusion Weighted Imaging (DWI) or Computerized Tomography Perfusion (CTP) Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention (DAWN)
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Secondary ID [1]
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T4024
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Universal Trial Number (UTN)
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Trial acronym
DAWN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ischemic Stroke
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Condition category
Condition code
Stroke
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Haemorrhagic
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Stroke
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Trevo Thrombectomy Procedure
Other interventions - Medical Management
Experimental: Trevo Thrombectomy Procedure - Trevo Thrombectomy Procedure and Medical Management
Active Comparator: Medical Management - Medical Management
Treatment: Devices: Trevo Thrombectomy Procedure
stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)
Other interventions: Medical Management
Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome
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Assessment method [1]
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mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.
Functional Independence:
0 - no symptoms at all
- no significant disability despite symptoms; able to carry out all usual duties and activities
- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
- moderate disability; requiring some help, but able to walk without assistance
- moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- severe disability; bedridden, incontinent and requiring constant nursing care and attention
- dead
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Timepoint [1]
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90 days
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Primary outcome [2]
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Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome
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Assessment method [2]
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Number of participants with functional independence
mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.
Functional Independence:
0 - no symptoms at all
- no significant disability despite symptoms; able to carry out all usual duties and activities
- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
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Timepoint [2]
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90 days
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Primary outcome [3]
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Stroke-related Mortality, Primary Safety Outcome
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Assessment method [3]
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Timepoint [3]
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90 days
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Secondary outcome [1]
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Good Functional Outcome
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Assessment method [1]
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Proportion of participants with functional independence
mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.
Functional Independence:
0 - no symptoms at all
- no significant disability despite symptoms; able to carry out all usual duties and activities
- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
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Timepoint [1]
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90 days
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Secondary outcome [2]
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Early Response
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Assessment method [2]
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The proportion of subjects with "early response" at Day 5-7/Discharge (whichever is earlier), defined as a National Institutes of Health Stroke Scale (NIHSS) drop of =10 from baseline or NIHSS score 0 or 1.
The NIHSS is an assessment which objectively quantifies the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
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Timepoint [2]
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5-7 Days
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Secondary outcome [3]
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All Cause Mortality
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Assessment method [3]
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Timepoint [3]
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90 days
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Secondary outcome [4]
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Revascularization Rates
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Assessment method [4]
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Revascularization rates at 24 hours from randomization are based on the assessment of vessel patency utilizing CTA/MRA and processed by the CT-MR core laboratory. Revascularization at 24 hours was defined as the presence of partial or complete recanalization.
CTA/MRA images utilized ionizing radiation exposure.
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Timepoint [4]
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24 hours
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Secondary outcome [5]
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Neurological Deterioration From Baseline NIHSS Score
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Assessment method [5]
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Neurological deterioration from baseline NIHSS score through Day 5-7/discharge (whichever is earlier) post randomization. Neurological deterioration is defined as = 4 point increase in the NIHSS score from the baseline score.
The calculated difference in NIHSS scores was assessed at baseline and Day 5-7/discharge (two time points).
The NIHSS is an assessment which objectively quantifies the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
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Timepoint [5]
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5-7 days
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Eligibility
Key inclusion criteria
General
1. Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke,
and subject belongs to one of the following subgroups:
1. Subject has failed IV t-PA therapy (defined as a confirmed persistent occlusion
60 min after administration)
2. Subject is contraindicated for IV t-PA administration
2. Age =18
3. Baseline NIHSS =10 (assessed within one hour of measuring core infarct volume)
4. Subject can be randomized between with 6 to 24 hours after time last known well
5. No significant pre-stroke disability (pre-stroke mRS must be 0 or 1)
6. Anticipated life expectancy of at least 6 months
7. Subject willing/able to return for protocol required follow up visits
8. Subject or subject's Legally Authorized Representative (LAR) has signed the study
Informed Consent form*
- If approved by local ethics committee and country regulations, the investigator
is allowed to enroll a patient utilizing emergency informed consent procedures if
neither the patient nor the representative or person of trust is available to
sign the informed consent form. However, as soon as possible, the patient is
informed and his/her consent is requested for the possible continuation of this
research. (Not applicable to U.S. Sites.)
Imaging
1. < 1/3 MCA territory involved, as evidenced by CT or MRI
2. Occlusion of the intracranial ICA and/or MCA-M1 as evidenced by MRA or CTA
3. Clinical Imaging Mismatch (CIM) defined as one of the following on MR-DWI or CTP-rCBF
maps:
1. 0-<21 cc core infarct and NIHSS = 10 (and age = 80 years old)
2. 0-<31 cc core infarct and NIHSS = 10 (and age < 80 years old)
3. 31 cc to <51 cc core infarct and NIHSS = 20 (and age < 80 years old)
General
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. History of severe head injury within past 90 days with residual neurological deficit,
as determined by medical history
2. Rapid improvement in neurological status to an NIHSS <10 or evidence of vessel
recanalization prior to randomization
3. Pre-existing neurological or psychiatric disease that would confound the neurological
or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor
(e.g. Aricept)
4. Seizures at stroke onset if it makes the diagnosis of stroke doubtful and precludes
obtaining an accurate baseline NIHSS assessment
5. Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol)
6. Baseline hemoglobin counts of <7 mmol/L
7. Baseline platelet count < 50,000/uL
8. Abnormal baseline electrolyte parameters as defined by sodium concentration <130
mmol/L, potassium concentration <3 mEq/L or >6 mEq/L
9. Renal failure as defined by a serum creatinine >3.0 mg/dL (264 µmol/L) NOTE: subjects
on renal dialysis may be treated regardless of serum creatinine levels
10. Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant
therapy with INR > 3.0 or PTT > 3 times normal. Patients on factor Xa inhibitor for
24-48 hours ago must have a normal PTT.
11. Any active or recent hemorrhage within the past 30 days
12. History of severe allergy (more than rash) to contrast medium
13. Severe, sustained hypertension (Systolic Blood Pressure >185 mmHg or Diastolic Blood
Pressure >110 mmHg) NOTE: If the blood pressure can be successfully reduced and
maintained at the acceptable level using medication the subject can be enrolled
14. Female who is pregnant or lactating at time of admission
15. Current participation in another investigational drug or device study
16. Presumed septic embolus, or suspicion of bacterial endocarditis
17. Treatment with any cleared thrombectomy devices or other intra-arterial
(neurovascular) therapies prior to randomization
Imaging
1. Evidence of intracranial hemorrhage on CT/MRI
2. CTA or MRA evidence of flow limiting carotid dissection, high-grade stenosis, or
complete cervical carotid occlusion requiring stenting at the time of the index
procedure (i.e., mechanical thrombectomy).
3. Excessive tortuosity of cervical vessels on CTA/MRA that would likely preclude device
delivery/deployment
4. Suspected cerebral vasculitis based on medical history and CTA/MRA
5. Suspected aortic dissection based on medical history and CTA/MRA
6. Intracranial stent implanted in the same vascular territory that would preclude the
safe deployment/removal of the Trevo device
7. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or
anterior circulation/vertebrobasilar system) as confirmed on CTA/MRA, or clinical
evidence of bilateral strokes or strokes in multiple territories
8. Significant mass effect with midline shift as confirmed on CT/MRI
9. Evidence of intracranial tumor (except small meningioma) as confirmed on CT/MRI
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/05/2017
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Sample size
Target
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Accrual to date
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Final
206
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Melbourne - Parkville
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Recruitment postcode(s) [1]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Delaware
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Georgia
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Country [5]
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United States of America
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State/province [5]
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Illinois
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Country [6]
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United States of America
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State/province [6]
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Kansas
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Country [7]
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United States of America
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State/province [7]
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Kentucky
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Country [8]
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United States of America
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State/province [8]
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Michigan
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Country [9]
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United States of America
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State/province [9]
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New Jersey
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Country [10]
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United States of America
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State/province [10]
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New York
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United States of America
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Ohio
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United States of America
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Pennsylvania
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Country [13]
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United States of America
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State/province [13]
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Tennessee
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Country [14]
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United States of America
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State/province [14]
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Texas
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Country [15]
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Canada
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State/province [15]
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Ontario
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Country [16]
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France
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State/province [16]
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Montpellier
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Country [17]
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France
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State/province [17]
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Toulouse
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Country [18]
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Spain
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State/province [18]
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Barcelona
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Stryker Neurovascular
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical
management leads to superior clinical outcomes at 90 days as compared to medical management
alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment
is initiated within 6-24 hours after last seen well.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02142283
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Tudor G Jovin, MD
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Address
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University of Pittsburg Medical Center Stroke Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02142283
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