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).
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.
Study Type
OBSERVATIONAL
Enrollment
1,492
Treatment of LVO with mechanical thrombectomy
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)
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
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.
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Banner Desert
Mesa, Arizona, United States
Kaiser Permanente Fontana
Fontana, California, United States
Kaiser Permanente LA
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Doctors Medical Center Modesto
Modesto, California, United States
UC Irvine
Orange, California, United States
Dignity Health/ Mercy San Juan
Rancho Cordova, California, United States
Stanford
Stanford, California, United States
St. Mary's Medical Center
Delray Beach, Florida, United States
Memorial Healthcare System
Hollywood, Florida, United States
...and 62 more locations
Time frame: 90 Days (±14 days)
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)
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)
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
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
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