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).
Brief Title
ASSIST Registry Studying Various Operator Techniques
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Ischemic Stroke
Eligibility Criteria
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.
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.
Inclusion Criteria
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,
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,
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03845491
Org Class
Industry
Org Full Name
Stryker Neurovascular
Org Study Id
CDM10001414
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
ASSIST Registry to Assess the Procedural Success and Clinical Outcomes Associated With Various Operator Techniques for Mechanical Thrombectomy in Large Vessel Occlusions (LVO).
Primary Outcomes
Outcome Description
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.
Outcome Measure
Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90
Outcome Time Frame
90 Days (±14 days)
Outcome Description
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
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
Outcome Measure
Percentage of Subjects Achieved eTICI 2c or Greater on First Pass (Adjudicated by the Core Lab)
Outcome Time Frame
At the time of procedure, after the first pass
Secondary Outcomes
Outcome Description
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.
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.
Outcome Time Frame
90 Days (±14 days)
Outcome Measure
Percentage of Subjects With an Excellent Functional Outcome at Day 90
Outcome Description
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.
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.
Outcome Time Frame
Discharge/ Day 5-7 (Whichever is earlier)
Outcome Measure
Percentage of Subjects With an "Early Response" Defined by NIHSS Score
Outcome Description
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.
Outcome Time Frame
Day 90 (±14 days)
Outcome Measure
Quality of Life at Day 90 Based on EQ5D5L Score
Outcome Description
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
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
Outcome Time Frame
At the time of procedure, after the first pass, and at the end of the procedure
Outcome Measure
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.
Outcome Description
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
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
Outcome Time Frame
During the procedure, from groin puncture to after the first pass
Outcome Measure
Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass
Outcome Description
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
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
Outcome Time Frame
Time of procedure, from groing puncture to revascularization
Outcome Measure
Overall Time From Groin Puncture to Achieve Final Reperfusion of eTICI 2c or 3
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Subjects experiencing acute ischemic stroke (AIS) who are eligible for restoration of blood flow using Stryker Neurovascular market-released products in the neurovasculature to remove thrombus
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Altschul
Investigator Email
daltschu@montefiore.org
Investigator Phone
718-920-7498