ASSIST Registry Studying Various Operator Techniques

Study Overview
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Brief Summary
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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
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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.

Official Title
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ASSIST Registry to Assess the Procedural Success and Clinical Outcomes Associated With Various Operator Techniques for Mechanical Thrombectomy in Large Vessel Occlusions (LVO).

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: Mechanical Thrombectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Subject is treated using at least one of the defined techniques for the first pass in the neurovasculature to remove thrombus. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SR Classic<br>SR (Trevo®]) + BGC (FlowGate2] or Merci) | Device: Mechanical Thrombectomy<br>* Treatment of LVO with mechanical thrombectomy<br>|
| SR Combination<br>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) | Device: Mechanical Thrombectomy<br>* Treatment of LVO with mechanical thrombectomy<br>|
| Direct Aspiration<br>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) | Device: Mechanical Thrombectomy<br>* Treatment of LVO with mechanical thrombectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of disability at Day 90 assessed by modified Rankin Scale (mRS) with a good functional outcome defined by mRS score. | Severity of disability at Day 90 (± 14) assessed by modified Rankin Scale (mRS) with a good functional outcome defined as mRS of 0-2 for each technique. | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with an excellent functional outcome at Day 90 | Proportion of subjects with an excellent functional outcome of mRS of 0-1 at Day 90 (± 14) | 90 Days | 
| Proportion of subjects with an early response defined by NIHSS score | Proportion 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 | Discharge/ Day 5-7 (Whichever is earlier) | 
| Quality of Life at day 90 based on EQ5D5L score | Quality of Life at Day 90 (± 14) assessed by EuroQoL (EQ5D5L) | Day 90 |