| 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.)
- 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 from another individual (use of walking aids alone is not counted as 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
| | Posted | | Count of Participants | | Participants | | 90 days | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| score of 0 | | | score of 1 | |
|
| |
| 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.)
- 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 from another individual (use of walking aids alone is not counted as 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
| | Posted | | Count of Participants | | Participants | | 90 days | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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 | 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. | Posted | | Count of Participants | | Participants | | post procedure within 6 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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 | 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. | Posted | | Median | Inter-Quartile Range | score on a scale | | 24-36 hours post procedure | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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.)
- 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 from another individual (use of walking aids alone is not counted as 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
| | Posted | | Count of Participants | | Participants | | 90 days | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 90 days | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | 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. | Posted | | Count of Participants | | Participants | | 18-36 hours post procedure | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | Number of Participants With All-cause Mortality | | | Posted | | Count of Participants | | Participants | | 18-36 hours post procedure | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Sedation | |
|
| Secondary | Number of Participants With Procedural Complications | | 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. | Posted | | Count of Participants | | Participants | | 18-36 hours post procedure | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Other Pre-specified | Time From Groin Puncture to Reperfusion | | 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. | Posted | | Median | Inter-Quartile Range | minutes | | post procedure within 6 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Other Pre-specified | Time From Door to TICI ≥ 2b Reperfusion | | 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. | Posted | | Median | Inter-Quartile Range | minutes | | post procedure within 6 hours | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|