Stroke
Conditions
Keywords
Acute stroke, Cerebral Stroke
Brief summary
Objectives: This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of symptomatic intracranial hemorrhage); rates of Endovascular therapy (EVT) procedural complications, reperfusion; and quality of life. Hypothesis: GA during EVT for acute ischemic stroke improves functional outcomes at 90 days compared to sedation.
Interventions
DRUGSedation
The protocol does not specify a particular combination of drugs that must be used for sedation. The most common drugs utilized for sedation and wide dosing ranges are included in the protocol (i.e., sedation will be provided under the supervision of an anesthesiologist and may use a combination of fentanyl, midazolam, dexmedetomidine infusion (with or without loading dose), and/or low-dose propofol by intermittent bolus or infusion); however, the choice of specific drugs and dosages for achieving conscious sedation or general anesthesia will not be specified by the protocol but will be up to the anesthesiologist.
The protocol doesn't specify drugs that must be used for GA, the choice of drugs and dosages for achieving general anesthesia will not be specified by the protocol but will be up to the anesthesiologist. The most common drugs utilized for GA and wide dosing ranges included in the protocol are (GA will be provided under the supervision of an anesthesiologist and induction of anesthesia may be achieved with propofol and/or etomidate; muscle paralysis may be achieved with succinylcholine or non-depolarizing paralytic (rocuronium or vecuronium); and adjuvant lidocaine and fentanyl; if intravenous maintenance of anesthesia is used, it may be achieved by propofol infusion at 50 to 150 mcg/kg/min with redosing of non-depolarizing paralytic and fentanyl as needed; if inhalational maintenance of anesthesia is used it will be achieved with sevoflurane 1% to 2% or desflurane 3% to 6% end-tidal concentration with redosing of non-depolarizing paralytic and fentanyl as needed)
PROCEDUREIntra-arterial Thrombectomy
The first line therapeutic embolectomy device should be a stent retriever. Additional Endovascular therapies including, but not limited to, intra- or extracranial angioplasty ± stenting; antithrombotics (oral, IV or IA antiplatelets or anticoagulants) intra-arterial thrombolytics; are left to the decision of the local treatment team.
Sponsors
Stryker Neurovascular
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Acute ischemic stroke due to large intracranial vessel occlusion demonstrated on CT-angiography in the following anterior circulation locations that will be treated by endovascular therapy (EVT): 1. Internal Carotid Artery (terminal T or L-type- occlusion) 2. Middle Cerebral Artery (MCA) M1 or proximal M2 3. Anterior Cerebral Artery (ACA) A1 or proximal A2 * Patients who receive IV-tPA thrombolysis are eligible provided the drug was delivered within 4.5 hours of stroke onset or last seen normal and in accordance with local hospital standard of care. 2. Ages 18-90. 3. National Institute of Health Stroke Scale (NIHSS) score 6-30 4. Time of from stroke symptom onset of last seen normal to start of EVT (defined as groin puncture) ≤ 16 hours. 5. Limited infarct core, as defined below and adapted from the 2018 American Heart Association guidelines 1. For patients presenting ≤ 6 hours from time of symptom onset or last seen normal, Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥ 6 2. For patients presenting \> 6 hours and ≤ 16 hours from time of symptom onset or last seen normal, they must satisfy EITHER ONE of the two following criteria: i. Ischemic core by CT Perfusion or MRI/MR Perfusion \< 70 mL, a ratio of volume of penumbral tissue to infarct core of ≥ 1.8, and and absolute volume of penumbral tissue of ≥ 15 mL OR ii. For patients with NIHSS ≥ 10, infarct core of \< 31 mL by CT Perfusion or MRI; For patients with NIHSS ≥ 20, infarct core \< 51 mL. 6. Subject willing/able to return for protocol required follow up visits. 7. No significant pre-stroke disability (modified Rankin Score must be ≤ 2). 8. Females of childbearing potential must have a negative serum or urine pregnancy test. 9. Patient or patient's legally authorized representative has given Informed Consent according to Good Clinical Practices (GCP) and/or local IRB policies.
Exclusion criteria
1. Coma on admission (Glasgow Coma Scale \<8), need for intubation upon ED arrival, or transferred patients who present previously intubated. 2. Severe agitation or seizures on admission that preclude safe vascular access. 3. Loss of airway protective reflexes and/or vomiting on admission. 4. Predicted or known difficult airway. 5. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia. 6. Presumed septic embolus, or suspicion of bacterial endocarditis 7. Currently participating or has participated in any investigational drug or device study within 30 days. 8. Inability to follow-up for 90-day assessment. 9. Known history of allergy to anesthesia drugs. 10. Known history or family history of malignant hyperthermia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Ordinal Rankin Scale (mRS) | 90 days | mRS ranges from 0 to 6, with higher scores indicating greater disability. 6 categories are reported: number of participants who had a score of 0, 1, 2, 3, or 4 will be reported separately as 5 categories, and those who had a score of 5 or 6 will be combined and reported as a single category. 0: no symptoms/normal (physical, cognitive etc.) 1. no significant disability despite symptoms; able to carry out all usual duties and activities 2. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance) 4. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. dead |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dichotomized Modified Ordinal Rankin Scale (mRS) | 90 days | The modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability and where 0-2 is generally considered a good outcome with individuals assuming complete functional independence. 2 categories are reported: number of participants who had a score of 0-2, and number who had a score of 3-6. 0: no symptoms/normal (physical, cognitive etc.) 1. no significant disability despite symptoms; able to carry out all usual duties and activities 2. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance) 4. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. dead |
| Number of Participants With Angiographic Reperfusion Defined as Modified a TICI Score of ≥ 2b | post procedure within 6 hours | The thrombolysis in cerebral infarction (TICI) grading system is a tool for determining the response of thrombolytic therapy for ischemic stroke. The TICI grade ranges from 0 to 3, with a higher score indicating greater perfusion. grade 0: no perfusion grade 1: penetration with minimal perfusion grade 2: partial perfusion grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal grade 3: complete perfusion |
| Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) | 24-36 hours post procedure | The National Institutes of Health Stroke Scale (NIHSS) is a tool used objectively quantify the impairment caused by a stroke. Total score ranges from 0 - 42, with a higher score indicating greater severity of impairment caused by stroke. 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke |
| Number of Participants With Functional Independence as Indicated by an mRS Score of 0, 1, or 2 | 90 days | The modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability and where 0-2 is generally considered a good outcome with individuals assuming complete functional independence. 0: no symptoms/normal (physical, cognitive etc.) 1. no significant disability despite symptoms; able to carry out all usual duties and activities 2. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance) 4. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. dead |
| Number of Participants With All-cause Mortality | 18-36 hours post procedure | — |
| Number of Participants With Procedural Complications | 18-36 hours post procedure | — |
| Quality of Life as Assessed by the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) Assessment | 90 days | The EQ-5D-5L score ranges from -0.59 to 1, where 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0. |
| Number of Participants With Symptomatic Intracerebral Hemorrhage | 18-36 hours post procedure | Symptomatic intracerebral hemorrhage was defined using the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) definition, a ≥ 4 point increase in NIHSS score with a parenchymal hemorrhage type 2 within 36 hours. |
Other
| Measure | Time frame |
|---|---|
| Time From Groin Puncture to Reperfusion | post procedure within 6 hours |
| Time From Door to TICI ≥ 2b Reperfusion | post procedure within 6 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| General Anesthesia General Anesthesia (GA): The protocol doesn't specify a particular combination of drugs that must be used for GA, the choice of drugs and dosages for achieving general anesthesia will not be specified by the protocol but will be up to the anesthesiologist.
The most common drugs utilized for GA and wide dosing ranges included in the protocol are (GA will be provided under the supervision of an anesthesiologist and induction of anesthesia may be achieved with propofol and/or etomidate; muscle paralysis may be achieved with succinylcholine or non-depolarizing paralytic (rocuronium or vecuronium); and adjuvant lidocaine and fentanyl; if intravenous maintenance of anesthesia is used, it may be achieved by propofol infusion at 50 to 150 mcg/kg/min with redosing of non-depolarizing paralytic and fentanyl as needed; if inhalational maintenance of anesthesia is used it will be achieved with sevoflurane 1% to 2% or desflurane 3% to 6% end-tidal concentration with redosing of non-depolarizing paralytic and fentanyl as needed)
Intra-arterial Thrombectomy: The first line therapeutic embolectomy device should be a stent retriever. Additional Endovascular therapies including, but not limited to, intra- or extracranial angioplasty ± stenting; antithrombotics (oral, IV or IA antiplatelets or anticoagulants) intra-arterial thrombolytics; are left to the decision of the local treatment team. | 128 |
| Sedation The protocol does not specify a particular combination of drugs that must be used for sedation. The choice of specific drugs and dosages for achieving sedation will be up to the anesthesiologist.
Sedation: The protocol does not specify a particular combination of drugs that must be used for sedation.
The most common drugs utilized for sedation and wide dosing ranges are included in the protocol (i.e., sedation will be provided under the supervision of an anesthesiologist and may use a combination of fentanyl, midazolam, dexmedetomidine infusion (with or without loading dose), and/or low-dose propofol by intermittent bolus or infusion); however, the choice of specific drugs and dosages for achieving conscious sedation or general anesthesia will not be specified by the protocol but will be up to the anesthesiologist.
Intra-arterial Thrombectomy: The first line therapeutic embolectomy device should be a stent retriever. Additional Endovascular therapies including, but not limited to, intra- or extracranial angioplasty ± stenting; antithrombotics (oral, IV or IA antiplatelets or anticoagulants) intra-arterial thrombolytics; are left to the decision of the local treatment team. | 129 |
| Total | 257 |
Baseline characteristics
| Characteristic | General Anesthesia | Sedation | Total |
|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 12.7 | 67.6 years STANDARD_DEVIATION 13.8 | 66.77 years STANDARD_DEVIATION 13.28 |
| Alberta Stroke Program Early CT Score | 8 score on a scale | 9 score on a scale | 9 score on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 21 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 98 Participants | 100 Participants | 198 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 8 Participants | 15 Participants |
| Number of Participants who received intravenous tissue-type plasminogen activator treatment | 78 Participants | 72 Participants | 150 Participants |
| Number of Participants with a history of diabetes | 26 Participants | 34 Participants | 60 Participants |
| Number of Participants with a History of Hypertension | 77 Participants | 95 Participants | 172 Participants |
| Number of Participants with a History of Stroke | 19 Participants | 24 Participants | 43 Participants |
| Number of Participants with Atrial Flutter/Atrial Fibrillation | 23 Participants | 32 Participants | 55 Participants |
| Number of Participants with Coronary artery disease | 9 Participants | 17 Participants | 26 Participants |
| Number of Participants with Peripheral Vascular Disease | 1 Participants | 4 Participants | 5 Participants |
| Number of participants with prior use of anticoagulants | 15 Participants | 30 Participants | 45 Participants |
| Number of participants with prior use of antiplatelets | 26 Participants | 36 Participants | 62 Participants |
| Pre-stroke mRS 0 | 102 Participants | 105 Participants | 207 Participants |
| Pre-stroke mRS 1 | 14 Participants | 12 Participants | 26 Participants |
| Pre-stroke mRS 2 | 12 Participants | 12 Participants | 24 Participants |
| Race/Ethnicity, Customized Race Asian | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Race Black | 38 Participants | 37 Participants | 75 Participants |
| Race/Ethnicity, Customized Race More than one race | 7 Participants | 7 Participants | 14 Participants |
| Race/Ethnicity, Customized Race Unknown | 16 Participants | 18 Participants | 34 Participants |
| Race/Ethnicity, Customized Race White | 64 Participants | 65 Participants | 129 Participants |
| Region of Enrollment United States | 128 participants | 129 participants | 257 participants |
| Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) | 15 score on a scale | 16 score on a scale | 15 score on a scale |
| Sex: Female, Male Female | 69 Participants | 55 Participants | 124 Participants |
| Sex: Female, Male Male | 59 Participants | 74 Participants | 133 Participants |
| Time from Angiosuite to Groin puncture | 17 minutes | 12 minutes | 15 minutes |
| Time from Door to Groin puncture | 78 minutes | 69 minutes | 71 minutes |
| Time from Stroke Onset to Endovascular Therapy 6 hours to 16 hours | 40 Participants | 40 Participants | 80 Participants |
| Time from Stroke Onset to Endovascular Therapy less than 6 hours | 88 Participants | 89 Participants | 177 Participants |
| Time from Stroke onset to Groin puncture | 488 minutes | 508 minutes | 495 minutes |
| Vessels Occluded anterior cerebral artery (ACA)- A1 | 1 Participants | 2 Participants | 3 Participants |
| Vessels Occluded anterior cerebral artery (ACA)- A2 Proximal | 1 Participants | 1 Participants | 2 Participants |
| Vessels Occluded Internal Carotid Artery (ICA) Terminus | 26 Participants | 22 Participants | 48 Participants |
| Vessels Occluded middle cerebral artery (MCA)- M1 | 77 Participants | 69 Participants | 146 Participants |
| Vessels Occluded middle cerebral artery (MCA)- M2 Proximal | 30 Participants | 33 Participants | 63 Participants |
| Vessels Occluded No Vessels Occluded | 6 Participants | 9 Participants | 15 Participants |
| Vessels Occluded Unknown | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 11 / 130 | 9 / 130 |
| other Total, other adverse events | 0 / 130 | 0 / 130 |
| serious Total, serious adverse events | 62 / 130 | 65 / 130 |
Outcome results
Primary
Modified Ordinal Rankin Scale (mRS)
mRS ranges from 0 to 6, with higher scores indicating greater disability. 6 categories are reported: number of participants who had a score of 0, 1, 2, 3, or 4 will be reported separately as 5 categories, and those who had a score of 5 or 6 will be combined and reported as a single category. 0: no symptoms/normal (physical, cognitive etc.) 1. no significant disability despite symptoms; able to carry out all usual duties and activities 2. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance) 4. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. dead
Time frame: 90 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| General Anesthesia | Modified Ordinal Rankin Scale (mRS) | score of 0 | 16 Participants |
| General Anesthesia | Modified Ordinal Rankin Scale (mRS) | score of 1 | 21 Participants |
| General Anesthesia | Modified Ordinal Rankin Scale (mRS) | score of 2 | 20 Participants |
| General Anesthesia | Modified Ordinal Rankin Scale (mRS) | score of 3 | 21 Participants |
| General Anesthesia | Modified Ordinal Rankin Scale (mRS) | score of 4 | 9 Participants |
| General Anesthesia | Modified Ordinal Rankin Scale (mRS) | score of 5 or 6 | 33 Participants |
| Sedation | Modified Ordinal Rankin Scale (mRS) | score of 4 | 16 Participants |
| Sedation | Modified Ordinal Rankin Scale (mRS) | score of 0 | 11 Participants |
| Sedation | Modified Ordinal Rankin Scale (mRS) | score of 3 | 24 Participants |
| Sedation | Modified Ordinal Rankin Scale (mRS) | score of 1 | 23 Participants |
| Sedation | Modified Ordinal Rankin Scale (mRS) | score of 5 or 6 | 33 Participants |
| Sedation | Modified Ordinal Rankin Scale (mRS) | score of 2 | 13 Participants |
Secondary
Dichotomized Modified Ordinal Rankin Scale (mRS)
The modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability and where 0-2 is generally considered a good outcome with individuals assuming complete functional independence. 2 categories are reported: number of participants who had a score of 0-2, and number who had a score of 3-6. 0: no symptoms/normal (physical, cognitive etc.) 1. no significant disability despite symptoms; able to carry out all usual duties and activities 2. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance) 4. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. dead
Time frame: 90 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| General Anesthesia | Dichotomized Modified Ordinal Rankin Scale (mRS) | Score of 0, 1, or 2 | 57 Participants |
| General Anesthesia | Dichotomized Modified Ordinal Rankin Scale (mRS) | Score of 3, 4, 5, or 6 | 63 Participants |
| Sedation | Dichotomized Modified Ordinal Rankin Scale (mRS) | Score of 0, 1, or 2 | 47 Participants |
| Sedation | Dichotomized Modified Ordinal Rankin Scale (mRS) | Score of 3, 4, 5, or 6 | 73 Participants |
Secondary
Number of Participants With All-cause Mortality
Time frame: 18-36 hours post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| General Anesthesia | Number of Participants With All-cause Mortality | 11 Participants |
| Sedation | Number of Participants With All-cause Mortality | 9 Participants |
Secondary
Number of Participants With Angiographic Reperfusion Defined as Modified a TICI Score of ≥ 2b
The thrombolysis in cerebral infarction (TICI) grading system is a tool for determining the response of thrombolytic therapy for ischemic stroke. The TICI grade ranges from 0 to 3, with a higher score indicating greater perfusion. grade 0: no perfusion grade 1: penetration with minimal perfusion grade 2: partial perfusion grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal grade 3: complete perfusion
Time frame: post procedure within 6 hours
Population: Data were not collected from 6 participants in the general anesthesia arm and 7 participants in the sedation arm because they did not undergo the angiogram procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| General Anesthesia | Number of Participants With Angiographic Reperfusion Defined as Modified a TICI Score of ≥ 2b | 118 Participants |
| Sedation | Number of Participants With Angiographic Reperfusion Defined as Modified a TICI Score of ≥ 2b | 116 Participants |
Secondary
Number of Participants With Functional Independence as Indicated by an mRS Score of 0, 1, or 2
The modified Rankin Scale (mRS) ranges from 0 to 6, with higher scores indicating greater disability and where 0-2 is generally considered a good outcome with individuals assuming complete functional independence. 0: no symptoms/normal (physical, cognitive etc.) 1. no significant disability despite symptoms; able to carry out all usual duties and activities 2. slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. moderate disability; requiring some help, but able to walk without assistance from another individual (use of walking aids alone is not counted as assistance) 4. moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. dead
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| General Anesthesia | Number of Participants With Functional Independence as Indicated by an mRS Score of 0, 1, or 2 | 57 Participants |
| Sedation | Number of Participants With Functional Independence as Indicated by an mRS Score of 0, 1, or 2 | 47 Participants |
Secondary
Number of Participants With Procedural Complications
Time frame: 18-36 hours post procedure
Population: Data were not collected from 2 participants in the General Anesthesia arm and Data were not collected from 4 participants in the Sedation arm because the angiogram procedure was not performed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| General Anesthesia | Number of Participants With Procedural Complications | 4 Participants |
| Sedation | Number of Participants With Procedural Complications | 5 Participants |
Secondary
Number of Participants With Symptomatic Intracerebral Hemorrhage
Symptomatic intracerebral hemorrhage was defined using the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) definition, a ≥ 4 point increase in NIHSS score with a parenchymal hemorrhage type 2 within 36 hours.
Time frame: 18-36 hours post procedure
Population: Data were not collected from 3 participants in the general anesthesia arm and Data were not collected from 4 participants in the Sedation arm because these participants did not undergo imaging at this timeframe therefore the data were not available for them.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| General Anesthesia | Number of Participants With Symptomatic Intracerebral Hemorrhage | 1 Participants |
| Sedation | Number of Participants With Symptomatic Intracerebral Hemorrhage | 3 Participants |
Secondary
Quality of Life as Assessed by the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) Assessment
The EQ-5D-5L score ranges from -0.59 to 1, where 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.
Time frame: 90 days
Population: Data were not collected from 16 participants in the general anesthesia arm and Data were not collected from 14 participants in the Sedation arm because the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) assessment was not administered to these participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| General Anesthesia | Quality of Life as Assessed by the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) Assessment | 0.47 score on a scale | Standard Deviation 0.44 |
| Sedation | Quality of Life as Assessed by the European Quality of Life (EuroQol) 5 Dimensions 5 Level Version (EQ-5D-5L) Assessment | 0.46 score on a scale | Standard Deviation 0.4 |
Secondary
Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS)
The National Institutes of Health Stroke Scale (NIHSS) is a tool used objectively quantify the impairment caused by a stroke. Total score ranges from 0 - 42, with a higher score indicating greater severity of impairment caused by stroke. 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke
Time frame: 24-36 hours post procedure
Population: Data were not collected for 8 participants in the General Anesthesia arm and 5 participants in the Sedation arm because the National Institutes of Health Stroke Scale (NIHSS) assessment was not performed for these participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| General Anesthesia | Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) | 7 score on a scale |
| Sedation | Score on the National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) | 6 score on a scale |
Other Pre-specified
Time From Door to TICI ≥ 2b Reperfusion
Time frame: post procedure within 6 hours
Population: Data were not collected from 6 participants in the General Anesthesia arm and 6 participants in the Sedation arm because they did not have the EVT procedure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| General Anesthesia | Time From Door to TICI ≥ 2b Reperfusion | 121 minutes |
| Sedation | Time From Door to TICI ≥ 2b Reperfusion | 116 minutes |
Other Pre-specified
Time From Groin Puncture to Reperfusion
Time frame: post procedure within 6 hours
Population: Data were not collected from 4 participants in the general anesthesia arm and 4 participants in the sedation arm because they did not undergo the EVT procedure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| General Anesthesia | Time From Groin Puncture to Reperfusion | 41 minutes |
| Sedation | Time From Groin Puncture to Reperfusion | 43 minutes |