ASSIST Registry to Assess the Procedural Success and Clinical Outcomes Associated With Various Operator Techniques for Mechanical Thrombectomy in Large Vessel Occlusions (LVO).
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischemic Stroke
- Sponsor
- Stryker Neurovascular
- Enrollment
- 1492
- Locations
- 72
- Primary Endpoint
- Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Occlusion of intracranial anterior circulation vessel
- •Subject or subject's legally authorized representative (LAR) has signed the informed consent form prior to or within 48 hours post-procedure
- •Subject is willing to comply with the protocol follow-up requirements
- •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.
Outcomes
Primary Outcomes
Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90
Time Frame: 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.
Percentage of Subjects Achieved eTICI 2c or Greater on First Pass (Adjudicated by the Core Lab)
Time Frame: 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
Secondary Outcomes
- Percentage of Subjects With an Excellent Functional Outcome at Day 90(90 Days (±14 days))
- Percentage of Subjects With an "Early Response" Defined by NIHSS Score(Discharge/ Day 5-7 (Whichever is earlier))
- Quality of Life at Day 90 Based on EQ5D5L Score(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.(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(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(Time of procedure, from groing puncture to revascularization)