ASSIST Registry Studying Various Operator Techniques

Completed

Conditions: Ischemic Stroke

Registration Number: NCT03845491

Lead Sponsor: Stryker Neurovascular

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1492

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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

Secondary Outcome Measures

Name	Time	Method
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.
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.
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
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

Trial Locations

Locations (72): 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
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Banner Desert
🇺🇸Mesa, Arizona, United States