Acute Ischemic Stroke
Conditions
Keywords
Ischemic stroke, Large vessel occlusion, Endovascular thrombectomy
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.
Detailed description
SELECT 2 is a prospective, phase III randomized, international, multicenter, assessor-blinded controlled trial evaluating the efficacy and safety of thrombectomy in patients with large core on either CT or advanced perfusion imaging treated within 0-24 hours from last known well. Patients with the final diagnosis of an acute ischemic stroke 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 within 0-24 hrs from last known well will be randomized in a 1:1 ratio into thrombectomy plus medical management vs medical management alone. Patient outcomes will be measured at baseline, 24 hours post, discharge, 30 days and 90 days. The primary endpoint is the Modified Rankin Scale (mRS) at 90 (+/- 15) days. The primary outcome is a shift on 90-day mRS. Secondary outcomes are favorable clinical outcomes: mRS score of 0-2, safety outcomes such the incidence of symptomatic intracranial hemorrhage (sICH per SITS-MOST) and Imaging endpoints such as infarct volume on MRI diffusion-weighted imaging (DWI) sequence (or CT if MRI not feasible) 24 to 72 hours after randomization. CT images will be read by iSchemaView automated ASPECTS as well as by a physician. In cases where there is disagreement, the physician reading will override the automated software reading. CT/MR perfusion images with mismatch determination will be read by iSchemaView automated RAPID software. All the images will be adjudicated by a blinded core lab at the University of Texas-Medical School at Houston. A maximum of 560 patients will be randomized across the study sites. Covariate adaptive randomization will be used to balance the distribution of important variables. Interim analyses will be conducted at 200 and 380 patients, at which time the study may stop for efficacy or futility.
Interventions
DEVICEEndovascular 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.
OTHERMedical 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.
Sponsors
Stryker Neurovascular
The University of Texas Health Science Center, Houston
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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 Inclusion Criteria: 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)
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score | 90 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Mortalities Within 90-day Follow-up | 90 days | — |
| 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 | 24 hours | — |
| Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up | 90 days | 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. |
| The 1-year Functional Outcome, as Measured by the Modified Rankin Scale Score | 1 year | 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 |
| Number of Participants With Functional Independence, Defined as mRS Score of 0-2 at 1-year Follow-up | 1 year | 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 |
| Number of Participants With Independent Ambulation, Defined as mRS Score of 0-3 at 1-year Follow-up | 1 year | 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 |
| Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up | 1 year | Quality of Life scores in mobility, depression,social and cognitive domains |
| Number of Participants That Achieved Functional Independence as Measured by a mRS Score of 0-2 at 90-day Follow-up | 90 days | 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 |
| Number of Participants That Achieved Independent Ambulation as Measured by a mRS Score of 0-3 at 90-day Follow-up | 90 days | 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 |
| Number of Patients That Suffered a Symptomatic Intracranial Hemorrhage (sICH) as Measured by the SITS-MOST Criteria | 24 hours | — |
| Number of Participants With Neurological Worsening Defined as a ≥4-point Increase on the NIHSS Score Due to the Stroke Itself | 24 hours | — |
| Number of Procedural Complications | 24 hours | 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 |
| Successful Reperfusion in the EVT Group, Defined as Modified Thrombolysis in Cerebral Ischemia (mTICI) Grade of 2b or Higher | at the end of endovascular thrombectomy procedure | — |
| Discharge Location | day 5-7 after randomization/at discharge (whichever is later) | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Suffered Parenchymal Hemorrhage Type 2 | 24 hours | — |
| Number of Participants Who Suffered a Subarachnoid Hemorrhage | 24 hours | — |
| Number of Participants Who Had a Hemicraniectomy During Index Hospitalization | day 5-7 after randomization/at discharge (whichever is later) | — |
| Length of Hospital Stay | Up to 90-day follow up visit | Was assessed if the patient was discharged at every follow-up visit to determine the length of the stay if the patient was not discharged at the time of previous follow-up visit. |
| Infarct Volume on MRI DWI Sequence (or CT if MRI Not Feasible) up to 7 Days After Randomization | Up to 7 days | Infarct volume on MRI DWI sequence (or CT if MRI not feasible) up to 7 days after randomization |
| Lesion Growth (Difference Between the Ischemic Core on Baseline Imaging and the Follow-up Infarct Volume) | 24 hours to 7 days | Lesion growth (difference between ischemic core on baseline imaging and the follow-up infarct volume) |
Countries
Australia, Canada, New Zealand, Spain, Switzerland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endovascular Thrombectomy Plus Medical Management Endovascular Thrombectomy: Patients will receive thrombectomy plus medical management. 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 used are FDA-approved: 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/without aspiration, is left up to the interventionalist.
Medical Management: Patients receive AHA guideline-directed medical therapy- includes IV thrombolytic therapy 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. Non-thrombolysis treated patients: includes aspirin 325 mg on day 1, then aspirin 81 mg or 325 mg thereafter, 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. | 178 |
| Medical Management 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. | 174 |
| Total | 352 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | Medical Management | Total | Endovascular Thrombectomy Plus Medical Management |
|---|---|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 12.6 | 65.2 years STANDARD_DEVIATION 12.6 | 65.1 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 60 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 134 Participants | 270 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 22 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 50 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants | 29 Participants | 13 Participants |
| Race (NIH/OMB) White | 130 Participants | 262 Participants | 132 Participants |
| Sex: Female, Male Female | 74 Participants | 145 Participants | 71 Participants |
| Sex: Female, Male Male | 100 Participants | 207 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 68 / 178 | 71 / 174 |
| other Total, other adverse events | 77 / 178 | 59 / 174 |
| serious Total, serious adverse events | 129 / 178 | 123 / 174 |
Outcome results
Primary
Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score
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
Time frame: 90 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score | 4 scores on a scale |
| Medical Management | Degree of Disability/Dependence as Measured by the Modified Rankin Scale (mRS) Score | 5 scores on a scale |
Secondary
Discharge Location
Time frame: day 5-7 after randomization/at discharge (whichever is later)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Discharge Location | Discharged to inpatient rehab facility | 72 Participants |
| Endovascular Thrombectomy Plus Medical Management | Discharge Location | Discharged to in-hospital death | 42 Participants |
| Endovascular Thrombectomy Plus Medical Management | Discharge Location | Discharged to skilled nursing facility | 23 Participants |
| Endovascular Thrombectomy Plus Medical Management | Discharge Location | Discharged to acute care facility | 11 Participants |
| Endovascular Thrombectomy Plus Medical Management | Discharge Location | Discharged to hospice or home hospice | 11 Participants |
| Endovascular Thrombectomy Plus Medical Management | Discharge Location | Discharged to home | 19 Participants |
| Medical Management | Discharge Location | Discharged to in-hospital death | 44 Participants |
| Medical Management | Discharge Location | Discharged to home | 10 Participants |
| Medical Management | Discharge Location | Discharged to acute care facility | 16 Participants |
| Medical Management | Discharge Location | Discharged to inpatient rehab facility | 65 Participants |
| Medical Management | Discharge Location | Discharged to skilled nursing facility | 20 Participants |
| Medical Management | Discharge Location | Discharged to hospice or home hospice | 19 Participants |
Secondary
Number of Mortalities Within 90-day Follow-up
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Number of Mortalities Within 90-day Follow-up | 68 Mortalities |
| Medical Management | Number of Mortalities Within 90-day Follow-up | 71 Mortalities |
Secondary
Number of Participants That Achieved Functional Independence as Measured by a mRS Score of 0-2 at 90-day Follow-up
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
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Number of Participants That Achieved Functional Independence as Measured by a mRS Score of 0-2 at 90-day Follow-up | 36 Participants |
| Medical Management | Number of Participants That Achieved Functional Independence as Measured by a mRS Score of 0-2 at 90-day Follow-up | 12 Participants |
Secondary
Number of Participants That Achieved Independent Ambulation as Measured by a mRS Score of 0-3 at 90-day Follow-up
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
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Number of Participants That Achieved Independent Ambulation as Measured by a mRS Score of 0-3 at 90-day Follow-up | 67 Participants |
| Medical Management | Number of Participants That Achieved Independent Ambulation as Measured by a mRS Score of 0-3 at 90-day Follow-up | 32 Participants |
Secondary
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
Time frame: 24 hours
Population: 4 participants in the Endovascular Thrombectomy plus medical management, and 1 participant in the medical management group did not have enough data available to be included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | 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 | 20 Participants |
| Medical Management | 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 | 13 Participants |
Secondary
Number of Participants With Functional Independence, Defined as mRS Score of 0-2 at 1-year Follow-up
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
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Number of Participants With Functional Independence, Defined as mRS Score of 0-2 at 1-year Follow-up | 40 Participants |
| Medical Management | Number of Participants With Functional Independence, Defined as mRS Score of 0-2 at 1-year Follow-up | 9 Participants |
Secondary
Number of Participants With Independent Ambulation, Defined as mRS Score of 0-3 at 1-year Follow-up
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
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Number of Participants With Independent Ambulation, Defined as mRS Score of 0-3 at 1-year Follow-up | 63 Participants |
| Medical Management | Number of Participants With Independent Ambulation, Defined as mRS Score of 0-3 at 1-year Follow-up | 29 Participants |
Secondary
Number of Participants With Neurological Worsening Defined as a ≥4-point Increase on the NIHSS Score Due to the Stroke Itself
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Number of Participants With Neurological Worsening Defined as a ≥4-point Increase on the NIHSS Score Due to the Stroke Itself | 44 Participants |
| Medical Management | Number of Participants With Neurological Worsening Defined as a ≥4-point Increase on the NIHSS Score Due to the Stroke Itself | 27 Participants |
Secondary
Number of Patients That Suffered a Symptomatic Intracranial Hemorrhage (sICH) as Measured by the SITS-MOST Criteria
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Number of Patients That Suffered a Symptomatic Intracranial Hemorrhage (sICH) as Measured by the SITS-MOST Criteria | 1 Participants |
| Medical Management | Number of Patients That Suffered a Symptomatic Intracranial Hemorrhage (sICH) as Measured by the SITS-MOST Criteria | 2 Participants |
Secondary
Number of Procedural Complications
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
Time frame: 24 hours
Population: Patients in the medical management group did not undergo procedure so no data was collected for that group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Number of Procedural Complications | 30 Procedural complications |
Secondary
Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up
Quality of Life scores in mobility, depression,social and cognitive domains
Time frame: 1 year
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up | Mobility domain | 40.8 score on a scale |
| Endovascular Thrombectomy Plus Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up | Depression domain | 45.3 score on a scale |
| Endovascular Thrombectomy Plus Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up | Social domain | 40.6 score on a scale |
| Endovascular Thrombectomy Plus Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up | Cognitive domain | 46 score on a scale |
| Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up | Cognitive domain | 38.9 score on a scale |
| Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up | Mobility domain | 27.2 score on a scale |
| Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up | Social domain | 35 score on a scale |
| Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 1 Year Follow-up | Depression domain | 52.1 score on a scale |
Secondary
Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up
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.
Time frame: 90 days
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up | Depression domain | 47.9 score on a scale |
| Endovascular Thrombectomy Plus Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up | Social domain | 37.1 score on a scale |
| Endovascular Thrombectomy Plus Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up | Cognitive domain | 41.9 score on a scale |
| Endovascular Thrombectomy Plus Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up | Mobility domain | 35.2 score on a scale |
| Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up | Cognitive domain | 37.9 score on a scale |
| Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up | Social domain | 33.5 score on a scale |
| Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up | Mobility domain | 25.1 score on a scale |
| Medical Management | Quality of Life Score, as Measured Using NeuroQOL at 90-day Follow-up | Depression domain | 53.6 score on a scale |
Secondary
Successful Reperfusion in the EVT Group, Defined as Modified Thrombolysis in Cerebral Ischemia (mTICI) Grade of 2b or Higher
Time frame: at the end of endovascular thrombectomy procedure
Population: Data was only collected for the Endovascular Thrombectomy plus Medical Management group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Successful Reperfusion in the EVT Group, Defined as Modified Thrombolysis in Cerebral Ischemia (mTICI) Grade of 2b or Higher | 142 Successful reperfusions |
Secondary
The 1-year Functional Outcome, as Measured by the Modified Rankin Scale Score
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
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | The 1-year Functional Outcome, as Measured by the Modified Rankin Scale Score | 5 score on a scale |
| Medical Management | The 1-year Functional Outcome, as Measured by the Modified Rankin Scale Score | 6 score on a scale |
Other Pre-specified
Infarct Volume on MRI DWI Sequence (or CT if MRI Not Feasible) up to 7 Days After Randomization
Infarct volume on MRI DWI sequence (or CT if MRI not feasible) up to 7 days after randomization
Time frame: Up to 7 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Infarct Volume on MRI DWI Sequence (or CT if MRI Not Feasible) up to 7 Days After Randomization | 178 mL |
| Medical Management | Infarct Volume on MRI DWI Sequence (or CT if MRI Not Feasible) up to 7 Days After Randomization | 168.5 mL |
Other Pre-specified
Length of Hospital Stay
Was assessed if the patient was discharged at every follow-up visit to determine the length of the stay if the patient was not discharged at the time of previous follow-up visit.
Time frame: Up to 90-day follow up visit
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Length of Hospital Stay | 9 Days |
| Medical Management | Length of Hospital Stay | 8 Days |
Other Pre-specified
Lesion Growth (Difference Between the Ischemic Core on Baseline Imaging and the Follow-up Infarct Volume)
Lesion growth (difference between ischemic core on baseline imaging and the follow-up infarct volume)
Time frame: 24 hours to 7 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Lesion Growth (Difference Between the Ischemic Core on Baseline Imaging and the Follow-up Infarct Volume) | 78 mL |
| Medical Management | Lesion Growth (Difference Between the Ischemic Core on Baseline Imaging and the Follow-up Infarct Volume) | 65.5 mL |
Other Pre-specified
Number of Participants Who Had a Hemicraniectomy During Index Hospitalization
Time frame: day 5-7 after randomization/at discharge (whichever is later)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Number of Participants Who Had a Hemicraniectomy During Index Hospitalization | 29 Participants |
| Medical Management | Number of Participants Who Had a Hemicraniectomy During Index Hospitalization | 26 Participants |
Other Pre-specified
Number of Participants Who Suffered a Subarachnoid Hemorrhage
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Number of Participants Who Suffered a Subarachnoid Hemorrhage | 4 Participants |
| Medical Management | Number of Participants Who Suffered a Subarachnoid Hemorrhage | 0 Participants |
Other Pre-specified
Number of Participants Who Suffered Parenchymal Hemorrhage Type 2
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Thrombectomy Plus Medical Management | Number of Participants Who Suffered Parenchymal Hemorrhage Type 2 | 2 Participants |
| Medical Management | Number of Participants Who Suffered Parenchymal Hemorrhage Type 2 | 1 Participants |