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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/NCT03876457
Registration number
NCT03876457
Ethics application status
Date submitted
8/03/2019
Date registered
15/03/2019
Date last updated
15/03/2024
Titles & IDs
Public title
SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke
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Scientific title
SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke
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Secondary ID [1]
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G180275, Pro00056862
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Universal Trial Number (UTN)
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Trial acronym
SELECT2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute 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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Neurological
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Other neurological disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Endovascular Thrombectomy
Other interventions - Medical Management
Experimental: Endovascular Thrombectomy plus Medical Management -
Active Comparator: Medical Management -
Treatment: Devices: Endovascular Thrombectomy
Patients randomized to endovascular thrombectomy arm will receive thrombectomy plus medical management. They will be treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices which will be used are FDA-approved stent retrievers: the Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with or without aspiration, will be left up to the interventionalist, with any of the FDA-approved devices approved in the study protocol or a combination of them.
Other interventions: Medical Management
Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
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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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Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score
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Assessment method [1]
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The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead
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Timepoint [1]
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90 days
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Secondary outcome [1]
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Number of Participants That Achieved Functional Independence as Measured by a mRS Score of 0-2 at 90-day Follow-up
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Assessment method [1]
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The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead
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Timepoint [1]
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90 days
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Secondary outcome [2]
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Number of Participants That Achieved Independent Ambulation as Measured by a mRS Score of 0-3 at 90-day Follow-up
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Assessment method [2]
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The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Score 0: No symptoms Score 1: No significant disability. Able to carry out all usual activities, despite some symptoms.
Score 2: Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
Score 3: Moderate disability. Requires some help, but able to walk unassisted. Score 4: Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
Score 5: Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Score 6: Dead
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Timepoint [2]
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90 days
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Secondary outcome [3]
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Number of Patients That Suffered a Symptomatic Intracranial Hemorrhage (sICH) as Measured by the SITS-MOST Criteria
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Assessment method [3]
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Timepoint [3]
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24 hours
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Secondary outcome [4]
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Number of Participants With Neurological Worsening Defined as a =4-point Increase on the NIHSS Score Due to the Stroke Itself
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Assessment method [4]
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Timepoint [4]
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24 hours
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Secondary outcome [5]
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Number of Mortalities Within 90-day Follow-up
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Assessment method [5]
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Timepoint [5]
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90 days
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Secondary outcome [6]
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Number of Procedural Complications
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Assessment method [6]
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The following were included in the complications counted:
Surgical site hematoma
Surgical site infection
Vascular injury (peripheral or intracranial dissection, perforation or others) caused by the endovascular procedure
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Timepoint [6]
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24 hours
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Secondary outcome [7]
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Successful Reperfusion in the EVT Group, Defined as Modified Thrombolysis in Cerebral Ischemia (mTICI) Grade of 2b or Higher
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Assessment method [7]
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Timepoint [7]
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at the end of endovascular thrombectomy procedure
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Secondary outcome [8]
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Discharge Location
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Assessment method [8]
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Timepoint [8]
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day 5-7 after randomization/at discharge (whichever is later)
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Secondary outcome [9]
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Number of Participants That Showed Early Neurological Improvement, Defined as Improvement of =8 Points on NIHSS at 24 Hours of Presentation or an NIHSS of 0-1
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Assessment method [9]
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Timepoint [9]
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24 hours
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Secondary outcome [10]
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Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up
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Assessment method [10]
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The Neurological Quality of Life score (NeuroQoL) is a patient-reported outcome measure that assesses the impact of neurological disorders on various aspects of a person's quality of life in neurological diseases and has measures developed across 17 different domains. The trial measured NeuroQoL scores for Mobility, Depression, Social and Cognitive domains. The scores provide a measure of an individual's quality of life in a given domain relative to a reference population, with a mean score of 50 and range of 0-100. A t-score of 50 indicates average quality of life, while scores above 50 indicate better-than-average quality of life and scores below 50 indicate poorer-than-average quality of life, except for depression domain - where lower scores indicate better and higher scores indicate worse quality of life.
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Timepoint [10]
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90 days
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Secondary outcome [11]
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The 1-year Functional Outcome, as Measured by the Modified Rankin Scale Score
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Assessment method [11]
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Timepoint [11]
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1 year
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Secondary outcome [12]
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Functional Independence, Defined as mRS Score of 0-2 at 1-year Follow-up
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Assessment method [12]
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Timepoint [12]
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1 year
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Secondary outcome [13]
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Independent Ambulation, Defined as mRS Score of 0-3 at 1-year Follow-up
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Assessment method [13]
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Timepoint [13]
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1 year
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Secondary outcome [14]
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Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up
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Assessment method [14]
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Timepoint [14]
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1 year
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Eligibility
Key inclusion criteria
1. Adults (18-85 years) with the final diagnosis of an acute ischemic stroke
2. NIH Stroke Scale Score (NIHSS) = 6
3. Last known well to groin puncture or medical management between 0 to 24 hours
4. Pre-stroke modified Rankin Scale score (mRS) of 0-1
5. Eligible for thrombectomy or medical management
6. Signed Informed Consent obtained
7. Subject willing to comply with the protocol follow-up requirements
8. Anticipated life expectancy of at least 3 months
Specific Neuroimaging
1. Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be
cervical or intracranial, with or without tandem MCA lesions) determined by MRA or CTA
2. Large infarct-core lesion on at least one of the following:
- 2.1. Non-Contrast CT (ASPECTS of 3-5),
- 2.2. CT perfusion (rCBF<30% =50cc),
- 2.3. MRI-DWI (ADC<620 =50cc)
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Minimum age
18
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Maximum age
85
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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. Inability to undergo CT angiography and/or CT perfusion imaging (e.g., renal
insufficiency, iodine/contrast allergy)
2. Co-morbid psychiatric or medical illnesses that would confound the neurological
assessments
3. Treatment with thrombolytic agent beyond 4.5 hours from last known well
4. Treated with thrombolytic agent 3-4.5 hours after last known well AND any of the
following:
- 1) age >80,
- 2) current anticoagulant use,
- 3) history of diabetes AND prior stroke,
- 4) NIHSS >25,
- 5) ischemic involvement of > 1/3 MCA territory
5. Current participation in another investigational drug or device study.
Neuroimaging Exclusion Criteria
1. Patients who have both ASPECTS of 6-10 on non-contrast CT AND core volume <50 cc on
perfusion imaging
2. Patients with very large core on non-contrast CT i.e. ASPECTS = 2
3. Evidence of intracranial tumor (except small meningioma), acute intracranial
hemorrhage, neoplasm, or arteriovenous malformation
4. A significant mass effect with midline shift
5. Evidence of internal carotid artery dissection that is flow limiting or aortic
dissection
6. Intracranial stent implanted in the same vascular territory that precludes the safe
deployment/removal of the neurothrombectomy device
7. Acute symptomatic arterial occlusions in more than one vascular territory confirmed on
CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).
8. Signs of established infarct and large area of cerebral edema on non-contrast CT
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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
11/10/2019
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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
16/11/2023
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Sample size
Target
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Accrual to date
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Final
352
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Liverpool Hospital - South Western Sydney Clinical School - Liverpool
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Recruitment hospital [2]
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The Royal Adelaide Hospital (RAH) - Adelaide
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Recruitment hospital [3]
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Royal Melbourne Hospital - Melbourne
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Recruitment postcode(s) [1]
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- Liverpool
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Recruitment postcode(s) [2]
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- Adelaide
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Recruitment postcode(s) [3]
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- Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Kansas
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Michigan
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New York
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Wisconsin
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Canada
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State/province [14]
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Alberta
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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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New Zealand
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State/province [16]
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Canterbury
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Spain
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State/province [17]
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Badalona
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Country [18]
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Spain
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Barcelona
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Spain
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Valladolid
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Switzerland
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Basel
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Funding & Sponsors
Primary sponsor type
Other
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Name
University Hospitals Cleveland Medical Center
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Stryker Neurovascular
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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The University of Texas Health Science Center, Houston
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Address [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
SELECT 2 evaluates the efficacy and safety of endovascular thrombectomy compared to medical
management alone in acute ischemic stroke patients due to a large vessel occlusion in the
distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion
imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: =50cc) or both and are treated within 0-24
hours from last known well.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03876457
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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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Amrou Sarraj, MD
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Address
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Case Western Reserve University - University Hospitals Cleveland Medical Center
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03876457
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