Ischemic Stroke
Conditions
Brief summary
The purpose of this Registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (LVO).
Detailed description
ASSIST is a prospective, global, consecutive enrollment Registry of anterior circulation acute ischemic stroke patients with an LVO who undergo treatment with one of the interventional techniques using Stryker Neurovascular devices for the first pass. The purpose of this Registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (LVO) in the anterior circulation. Data will be collected on the use of Stryker market-released neurovascular mechanical access and mechanical thrombectomy devices that are commercially available or that may be approved for commercial use during the conduct of the Registry. This Registry will also collect data, including time-to-treatment and quality of life measures, to allow for subset analyses.
Interventions
DEVICEMechanical Thrombectomy
Treatment of LVO with mechanical thrombectomy
Sponsors
Stryker Neurovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects who experienced acute ischemic stroke (AIS), eligible for restoration of blood flow using Stryker Neurovascular market-released products in the neurovasculature to remove thrombus 2. Occlusion of intracranial anterior circulation vessel 3. Subject or subject's legally authorized representative (LAR) has signed the informed consent form prior to or within 48 hours post-procedure 4. Subject is willing to comply with the protocol follow-up requirements 5. The intended technique and treated technique must be one of the following techniques for the first thrombectomy pass in the neurovasculature per Instructions For Use (IFU): Technique Category/Devices: SR Classic/SR + BGC, SR Combination/SR + Asp Cath ± Pump + BGC or LS, Direct Aspiration/Asp Cath ± Pump + BGC or LS,
Exclusion criteria
The subject is participating in another device trial or any other clinical trial where the study procedure or treatment might confound this study's endpoint.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieved eTICI 2c or Greater on First Pass (Adjudicated by the Core Lab) | At the time of procedure, after the first pass | This outcome measures percentage of subjects who achieved complete reperfusion after the first pass, defined by eTICI score of 2c or greater. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: * 0: Equivalent to no reperfusion or 0% filling of the downstream territory * 1: Reflects thrombus reduction without any reperfusion of distal arteries * 2a: Reperfusion in less than half or 1-49% of the territory * 2b50: 50-66% reperfusion * 2b67: 67-89% reperfusion * 2c: 90-99% reperfusion * 3: Complete or 100% reperfusion |
| Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90 | 90 Days (±14 days) | This measure assesses clinical outcome using the Modified Rankin Scale (mRS). Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is a score ranging from 0-6 with the following degree of disability: 0 = No symptoms at all; no limitations and no symptoms; 1 = No significant disability, 2 = Slight disability; 3 = Moderate disability; 4 = Moderate severe disability, 5 = Severe disability; 6= Death. The lower mRS Score indicates less disability, and higher score indicates increased disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With an Early Response Defined by NIHSS Score | Discharge/ Day 5-7 (Whichever is earlier) | Percentage of subjects with an early response at Discharge/Day5-7 (whichever is earlier) defined as a NIHSS drop of ≥10 points from baseline or NIHSS score of 0 or 1. NIHSS (National Institutes of Health Stroke Scale) is an assessment to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a total NIHSS score. The maximum possible score is 42, with the minimum score being a 0. |
| Quality of Life at Day 90 Based on EQ5D5L Score | Day 90 (±14 days) | The Euro Quality of Life Questionnaire - 5 Level 5D Version (EQ5D5L) is composed of 5 dimensions- mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is evaluated by the subject on 5 level scale: no problems, slight problems, moderate problems, severe problems and extreme problems. The outcome reported shows severe and extreme levels were combined and only 4 levels are reported. |
| Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass | During the procedure, from groin puncture to after the first pass | This outcome measures overall time (in minutes) observed from groin puncture to the specific eTICI reperfusion score at end of first pass for treatment of target occlusion. Each subject can only be in one eTICI category and therefore they are mutually exclusive. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: * 0: Equivalent to no reperfusion or 0% filling of the downstream territory * 1: Reflects thrombus reduction without any reperfusion of distal arteries * 2a: Reperfusion in less than half or 1-49% of the territory * 2b50: 50-66% reperfusion * 2b67: 67-89% reperfusion * 2c: 90-99% reperfusion * 3: Complete or 100% reperfusion |
| Overall Time From Groin Puncture to Achieve Final Reperfusion of eTICI 2c or 3 | Time of procedure, from groing puncture to revascularization | This outcome measures the overall time (in minutes) observed from groin puncture to final reperfusion of eTICI 2c or 3 for treatment of target occlusion. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: * 0: Equivalent to no reperfusion or 0% filling of the downstream territory * 1: Reflects thrombus reduction without any reperfusion of distal arteries * 2a: Reperfusion in less than half or 1-49% of the territory * 2b50: 50-66% reperfusion * 2b67: 67-89% reperfusion * 2c: 90-99% reperfusion * 3: Complete or 100% reperfusion |
| Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the time of procedure, after the first pass, and at the end of the procedure | This outcome reports percentage of subjects who achieved eTICI 2b50, eTICI 2b67, eTICI 2c,or eTICI 3 on first pass after primary technique used and at the end of the endovascular procedure. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: * 0: Equivalent to no reperfusion or 0% filling of the downstream territory * 1: Reflects thrombus reduction without any reperfusion of distal arteries * 2a: Reperfusion in less than half or 1-49% of the territory * 2b50: 50-66% reperfusion * 2b67: 67-89% reperfusion * 2c: 90-99% reperfusion * 3: Complete or 100% reperfusion |
| Percentage of Subjects With an Excellent Functional Outcome at Day 90 | 90 Days (±14 days) | Percentage of subjects with an excellent functional outcome of mRS of 0-1 at Day 90 (± 14). Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is a score ranging from 0-6 with the following degree of disability: 0 = No symptoms at all, no limitations and no symptoms; 1 = No significant disability, 2 = Slight disability; 3 = Moderate disability; 4 = Moderate severe disability, 5 = Severe disability; 6= Death. The lower mRS Score indicates less disability. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcomes | 90 Days (+/- 14 Days) | Prespecified safety outcome measures include all-cause mortality and stroke-related mortality up to 90 days (±14), device and/or procedure related SAEs up to 90 Days (±14), neurological deterioration at 24 hours post procedure, embolization to new territory adjudicated by core lab. and neurological deterioration at 24 hours post-procedure to 48 hours |
Countries
Belgium, Canada, Czechia, France, Germany, Italy, South Korea, Spain, Switzerland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SR Classic SR (Trevo®\]) + BGC (FlowGate2\] or Merci)
Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy | 247 |
| SR Combination SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus)
or
SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci)
Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy | 697 |
| Direct Aspiration Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus)
or
Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci)
Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy | 548 |
| Total | 1,492 |
Baseline characteristics
| Characteristic | SR Classic | SR Combination | Direct Aspiration | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 181 Participants | 506 Participants | 355 Participants | 1042 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants | 191 Participants | 192 Participants | 449 Participants |
| Age, Continuous | 71.4 Years STANDARD_DEVIATION 14.3 | 71.8 Years STANDARD_DEVIATION 13.1 | 68.1 Years STANDARD_DEVIATION 15.4 | 70.4 Years STANDARD_DEVIATION 14.3 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Belgium | 14 participants | 45 participants | 3 participants | 62 participants |
| Region of Enrollment Canada | 1 participants | 12 participants | 2 participants | 15 participants |
| Region of Enrollment Czechia | 20 participants | 16 participants | 4 participants | 40 participants |
| Region of Enrollment France | 0 participants | 17 participants | 2 participants | 19 participants |
| Region of Enrollment Germany | 0 participants | 115 participants | 52 participants | 167 participants |
| Region of Enrollment Italy | 1 participants | 42 participants | 52 participants | 95 participants |
| Region of Enrollment South Korea | 20 participants | 33 participants | 11 participants | 64 participants |
| Region of Enrollment Spain | 144 participants | 45 participants | 133 participants | 322 participants |
| Region of Enrollment Switzerland | 0 participants | 45 participants | 8 participants | 53 participants |
| Region of Enrollment United Kingdom | 0 participants | 0 participants | 1 participants | 1 participants |
| Region of Enrollment United States | 47 participants | 327 participants | 280 participants | 654 participants |
| Sex: Female, Male Female | 121 Participants | 379 Participants | 281 Participants | 781 Participants |
| Sex: Female, Male Male | 126 Participants | 318 Participants | 267 Participants | 711 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 28 / 247 | 105 / 697 | 76 / 548 |
| other Total, other adverse events | 26 / 247 | 44 / 697 | 27 / 548 |
| serious Total, serious adverse events | 69 / 247 | 220 / 697 | 176 / 548 |
Outcome results
Primary
Percentage of Subjects Achieved eTICI 2c or Greater on First Pass (Adjudicated by the Core Lab)
This outcome measures percentage of subjects who achieved complete reperfusion after the first pass, defined by eTICI score of 2c or greater. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: * 0: Equivalent to no reperfusion or 0% filling of the downstream territory * 1: Reflects thrombus reduction without any reperfusion of distal arteries * 2a: Reperfusion in less than half or 1-49% of the territory * 2b50: 50-66% reperfusion * 2b67: 67-89% reperfusion * 2c: 90-99% reperfusion * 3: Complete or 100% reperfusion
Time frame: At the time of procedure, after the first pass
Population: Available core lab adjudicated procedural endpoint data of the enrolled subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SR Classic | Percentage of Subjects Achieved eTICI 2c or Greater on First Pass (Adjudicated by the Core Lab) | 110 Participants |
| SR Combination | Percentage of Subjects Achieved eTICI 2c or Greater on First Pass (Adjudicated by the Core Lab) | 309 Participants |
| Direct Aspiration | Percentage of Subjects Achieved eTICI 2c or Greater on First Pass (Adjudicated by the Core Lab) | 193 Participants |
Primary
Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90
This measure assesses clinical outcome using the Modified Rankin Scale (mRS). Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is a score ranging from 0-6 with the following degree of disability: 0 = No symptoms at all; no limitations and no symptoms; 1 = No significant disability, 2 = Slight disability; 3 = Moderate disability; 4 = Moderate severe disability, 5 = Severe disability; 6= Death. The lower mRS Score indicates less disability, and higher score indicates increased disability.
Time frame: 90 Days (±14 days)
Population: Available mRS scores at 90Days (±14 days) of the enrolled population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SR Classic | Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90 | 140 Participants |
| SR Combination | Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90 | 351 Participants |
| Direct Aspiration | Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90 | 273 Participants |
Secondary
Overall Time From Groin Puncture to Achieve Final Reperfusion of eTICI 2c or 3
This outcome measures the overall time (in minutes) observed from groin puncture to final reperfusion of eTICI 2c or 3 for treatment of target occlusion. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: * 0: Equivalent to no reperfusion or 0% filling of the downstream territory * 1: Reflects thrombus reduction without any reperfusion of distal arteries * 2a: Reperfusion in less than half or 1-49% of the territory * 2b50: 50-66% reperfusion * 2b67: 67-89% reperfusion * 2c: 90-99% reperfusion * 3: Complete or 100% reperfusion
Time frame: Time of procedure, from groing puncture to revascularization
Population: Limited to subjects who achieved eTICI 2c or 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SR Classic | Overall Time From Groin Puncture to Achieve Final Reperfusion of eTICI 2c or 3 | 29.17 Minutes | Standard Deviation 19.3 |
| SR Combination | Overall Time From Groin Puncture to Achieve Final Reperfusion of eTICI 2c or 3 | 31.26 Minutes | Standard Deviation 17.5 |
| Direct Aspiration | Overall Time From Groin Puncture to Achieve Final Reperfusion of eTICI 2c or 3 | 27.05 Minutes | Standard Deviation 19.2 |
Secondary
Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure.
This outcome reports percentage of subjects who achieved eTICI 2b50, eTICI 2b67, eTICI 2c,or eTICI 3 on first pass after primary technique used and at the end of the endovascular procedure. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: * 0: Equivalent to no reperfusion or 0% filling of the downstream territory * 1: Reflects thrombus reduction without any reperfusion of distal arteries * 2a: Reperfusion in less than half or 1-49% of the territory * 2b50: 50-66% reperfusion * 2b67: 67-89% reperfusion * 2c: 90-99% reperfusion * 3: Complete or 100% reperfusion
Time frame: At the time of procedure, after the first pass, and at the end of the procedure
Population: Subjects with available 90 Day core lab imaging data
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SR Classic | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | After First Pass | eTICI 0, 1, or 2a | 66 Participants |
| SR Classic | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | After First Pass | eTICI 2b50 | 16 Participants |
| SR Classic | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | After First Pass | eTICI 2b67 | 41 Participants |
| SR Classic | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | After First Pass | eTICI 2c | 31 Participants |
| SR Classic | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | After First Pass | eTICI 3 | 79 Participants |
| SR Classic | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the End of Procedure | eTICI 0, 1, or 2a | 7 Participants |
| SR Classic | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the End of Procedure | eTICI 2b50 | 2 Participants |
| SR Classic | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the End of Procedure | eTICI 2b67 | 65 Participants |
| SR Classic | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the End of Procedure | eTICI 2c | 57 Participants |
| SR Classic | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the End of Procedure | eTICI 3 | 114 Participants |
| SR Combination | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the End of Procedure | eTICI 2c | 238 Participants |
| SR Combination | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | After First Pass | eTICI 0, 1, or 2a | 179 Participants |
| SR Combination | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the End of Procedure | eTICI 0, 1, or 2a | 33 Participants |
| SR Combination | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | After First Pass | eTICI 3 | 160 Participants |
| SR Combination | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | After First Pass | eTICI 2b50 | 55 Participants |
| SR Combination | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the End of Procedure | eTICI 3 | 211 Participants |
| SR Combination | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the End of Procedure | eTICI 2b67 | 172 Participants |
| SR Combination | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | After First Pass | eTICI 2b67 | 137 Participants |
| SR Combination | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the End of Procedure | eTICI 2b50 | 38 Participants |
| SR Combination | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | After First Pass | eTICI 2c | 149 Participants |
| Direct Aspiration | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the End of Procedure | eTICI 2b67 | 134 Participants |
| Direct Aspiration | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | After First Pass | eTICI 2c | 105 Participants |
| Direct Aspiration | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | After First Pass | eTICI 3 | 88 Participants |
| Direct Aspiration | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the End of Procedure | eTICI 0, 1, or 2a | 17 Participants |
| Direct Aspiration | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the End of Procedure | eTICI 2c | 200 Participants |
| Direct Aspiration | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the End of Procedure | eTICI 2b50 | 36 Participants |
| Direct Aspiration | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | After First Pass | eTICI 0, 1, or 2a | 200 Participants |
| Direct Aspiration | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | At the End of Procedure | eTICI 3 | 157 Participants |
| Direct Aspiration | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | After First Pass | eTICI 2b50 | 52 Participants |
| Direct Aspiration | Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure. | After First Pass | eTICI 2b67 | 84 Participants |
Secondary
Percentage of Subjects With an Early Response Defined by NIHSS Score
Percentage of subjects with an early response at Discharge/Day5-7 (whichever is earlier) defined as a NIHSS drop of ≥10 points from baseline or NIHSS score of 0 or 1. NIHSS (National Institutes of Health Stroke Scale) is an assessment to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Time frame: Discharge/ Day 5-7 (Whichever is earlier)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SR Classic | Percentage of Subjects With an Early Response Defined by NIHSS Score | 156 Participants |
| SR Combination | Percentage of Subjects With an Early Response Defined by NIHSS Score | 376 Participants |
| Direct Aspiration | Percentage of Subjects With an Early Response Defined by NIHSS Score | 294 Participants |
Secondary
Percentage of Subjects With an Excellent Functional Outcome at Day 90
Percentage of subjects with an excellent functional outcome of mRS of 0-1 at Day 90 (± 14). Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is a score ranging from 0-6 with the following degree of disability: 0 = No symptoms at all, no limitations and no symptoms; 1 = No significant disability, 2 = Slight disability; 3 = Moderate disability; 4 = Moderate severe disability, 5 = Severe disability; 6= Death. The lower mRS Score indicates less disability.
Time frame: 90 Days (±14 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SR Classic | Percentage of Subjects With an Excellent Functional Outcome at Day 90 | 112 Participants |
| SR Combination | Percentage of Subjects With an Excellent Functional Outcome at Day 90 | 264 Participants |
| Direct Aspiration | Percentage of Subjects With an Excellent Functional Outcome at Day 90 | 209 Participants |
Secondary
Quality of Life at Day 90 Based on EQ5D5L Score
The Euro Quality of Life Questionnaire - 5 Level 5D Version (EQ5D5L) is composed of 5 dimensions- mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is evaluated by the subject on 5 level scale: no problems, slight problems, moderate problems, severe problems and extreme problems. The outcome reported shows severe and extreme levels were combined and only 4 levels are reported.
Time frame: Day 90 (±14 days)
Population: The analysis population is based on availability of the self reported data
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Mobility: | Moderate Problems | 22 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Pain/Discomfort: | Slight Problems | 50 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Self-care: | Severe/Extreme Problems | 17 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Anxiety/Depression: | Severe/Extreme Problems | 12 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Pain/Discomfort: | No Problems | 110 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Usual Activities | No Problems | 95 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Anxiety/Depression: | Slight Problems | 41 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Usual Activities | Severe/Extreme Problems | 17 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Usual Activities | Slight Problems | 44 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Mobility: | Severe/Extreme Problems | 21 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Usual Activities | Moderate Problems | 26 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Mobility: | Slight Problems | 36 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Anxiety/Depression: | No Problems | 118 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Self-care: | No Problems | 116 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Mobility: | No Problems | 103 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Pain/Discomfort: | Severe/Extreme Problems | 2 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Self-care: | Slight Problems | 30 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Anxiety/Depression: | Moderate Problems | 11 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Pain/Discomfort: | Moderate Problems | 20 Participants |
| SR Classic | Quality of Life at Day 90 Based on EQ5D5L Score | Self-care: | Moderate Problems | 19 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Self-care: | No Problems | 293 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Mobility: | No Problems | 247 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Mobility: | Slight Problems | 94 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Mobility: | Moderate Problems | 68 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Mobility: | Severe/Extreme Problems | 83 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Anxiety/Depression: | Moderate Problems | 85 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Self-care: | Slight Problems | 70 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Self-care: | Moderate Problems | 53 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Self-care: | Severe/Extreme Problems | 76 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Usual Activities | No Problems | 212 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Usual Activities | Slight Problems | 107 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Usual Activities | Moderate Problems | 77 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Usual Activities | Severe/Extreme Problems | 96 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Pain/Discomfort: | No Problems | 261 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Pain/Discomfort: | Slight Problems | 124 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Pain/Discomfort: | Moderate Problems | 78 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Pain/Discomfort: | Severe/Extreme Problems | 28 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Anxiety/Depression: | No Problems | 253 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Anxiety/Depression: | Slight Problems | 125 Participants |
| SR Combination | Quality of Life at Day 90 Based on EQ5D5L Score | Anxiety/Depression: | Severe/Extreme Problems | 26 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Self-care: | Moderate Problems | 38 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Anxiety/Depression: | Slight Problems | 107 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Pain/Discomfort: | Slight Problems | 99 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Self-care: | Slight Problems | 68 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Mobility: | Slight Problems | 77 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Pain/Discomfort: | Moderate Problems | 59 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Self-care: | No Problems | 227 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Anxiety/Depression: | Moderate Problems | 46 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Pain/Discomfort: | Severe/Extreme Problems | 21 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Mobility: | Severe/Extreme Problems | 64 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Mobility: | No Problems | 187 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Usual Activities | Slight Problems | 96 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Anxiety/Depression: | No Problems | 201 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Usual Activities | Moderate Problems | 61 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Usual Activities | No Problems | 154 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Mobility: | Moderate Problems | 56 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Usual Activities | Severe/Extreme Problems | 73 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Self-care: | Severe/Extreme Problems | 51 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Anxiety/Depression: | Severe/Extreme Problems | 29 Participants |
| Direct Aspiration | Quality of Life at Day 90 Based on EQ5D5L Score | Pain/Discomfort: | No Problems | 205 Participants |
Secondary
Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass
This outcome measures overall time (in minutes) observed from groin puncture to the specific eTICI reperfusion score at end of first pass for treatment of target occlusion. Each subject can only be in one eTICI category and therefore they are mutually exclusive. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: * 0: Equivalent to no reperfusion or 0% filling of the downstream territory * 1: Reflects thrombus reduction without any reperfusion of distal arteries * 2a: Reperfusion in less than half or 1-49% of the territory * 2b50: 50-66% reperfusion * 2b67: 67-89% reperfusion * 2c: 90-99% reperfusion * 3: Complete or 100% reperfusion
Time frame: During the procedure, from groin puncture to after the first pass
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SR Classic | Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass | eTICI 2b50 | 21.94 Minutes | Standard Deviation 8.5 |
| SR Classic | Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass | eTICI 2b67 | 25.68 Minutes | Standard Deviation 17 |
| SR Classic | Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass | eTICI 2c | 22.77 Minutes | Standard Deviation 11.2 |
| SR Classic | Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass | eTICI 3 | 23.19 Minutes | Standard Deviation 13.6 |
| SR Combination | Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass | eTICI 3 | 27.17 Minutes | Standard Deviation 16 |
| SR Combination | Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass | eTICI 2b50 | 23.31 Minutes | Standard Deviation 12.4 |
| SR Combination | Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass | eTICI 2c | 27.59 Minutes | Standard Deviation 13.7 |
| SR Combination | Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass | eTICI 2b67 | 28.85 Minutes | Standard Deviation 16.5 |
| Direct Aspiration | Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass | eTICI 3 | 20.40 Minutes | Standard Deviation 10.7 |
| Direct Aspiration | Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass | eTICI 2b67 | 19.24 Minutes | Standard Deviation 12.3 |
| Direct Aspiration | Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass | eTICI 2c | 18.61 Minutes | Standard Deviation 14 |
| Direct Aspiration | Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass | eTICI 2b50 | 20.14 Minutes | Standard Deviation 13.9 |
Other Pre-specified
Safety Outcomes
Prespecified safety outcome measures include all-cause mortality and stroke-related mortality up to 90 days (±14), device and/or procedure related SAEs up to 90 Days (±14), neurological deterioration at 24 hours post procedure, embolization to new territory adjudicated by core lab. and neurological deterioration at 24 hours post-procedure to 48 hours
Time frame: 90 Days (+/- 14 Days)
Population: The analysis population for each variable determined by available imaging data from the Core Lab
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SR Classic | Safety Outcomes | Symptomatic ICH up to 48 hrs post-procedure | 5 Participants |
| SR Classic | Safety Outcomes | Device and/or procedure related SAEs at 90 days (±14 days) | 16 Participants |
| SR Classic | Safety Outcomes | Access Site Complications up to 48 hrs post-procedure | 3 Participants |
| SR Classic | Safety Outcomes | Embolization to New Territory during procedure (Core Lab) | 2 Participants |
| SR Classic | Safety Outcomes | Neurological Deterioration (4 or greater increase in NIHSS) up to 48 hrs post-procedure | 13 Participants |
| SR Classic | Safety Outcomes | Stroke-related Mortality at 90 days (±14 days) | 19 Participants |
| SR Classic | Safety Outcomes | All-cause Mortality at 90 days (±14 days) | 28 Participants |
| SR Combination | Safety Outcomes | Access Site Complications up to 48 hrs post-procedure | 10 Participants |
| SR Combination | Safety Outcomes | All-cause Mortality at 90 days (±14 days) | 105 Participants |
| SR Combination | Safety Outcomes | Stroke-related Mortality at 90 days (±14 days) | 63 Participants |
| SR Combination | Safety Outcomes | Device and/or procedure related SAEs at 90 days (±14 days) | 40 Participants |
| SR Combination | Safety Outcomes | Embolization to New Territory during procedure (Core Lab) | 6 Participants |
| SR Combination | Safety Outcomes | Symptomatic ICH up to 48 hrs post-procedure | 15 Participants |
| SR Combination | Safety Outcomes | Neurological Deterioration (4 or greater increase in NIHSS) up to 48 hrs post-procedure | 52 Participants |
| Direct Aspiration | Safety Outcomes | Stroke-related Mortality at 90 days (±14 days) | 38 Participants |
| Direct Aspiration | Safety Outcomes | Neurological Deterioration (4 or greater increase in NIHSS) up to 48 hrs post-procedure | 47 Participants |
| Direct Aspiration | Safety Outcomes | Symptomatic ICH up to 48 hrs post-procedure | 14 Participants |
| Direct Aspiration | Safety Outcomes | All-cause Mortality at 90 days (±14 days) | 76 Participants |
| Direct Aspiration | Safety Outcomes | Device and/or procedure related SAEs at 90 days (±14 days) | 23 Participants |
| Direct Aspiration | Safety Outcomes | Access Site Complications up to 48 hrs post-procedure | 2 Participants |
| Direct Aspiration | Safety Outcomes | Embolization to New Territory during procedure (Core Lab) | 3 Participants |