ASSIST Registry to Assess the Procedural Success and Clinical Outcomes Associated With Various Operator Techniques for Mechanical Thrombectomy in Large Vessel Occlusions (LVO).
Conditions: Ischemic Stroke
Sponsor: Stryker Neurovascular

 
 
 
 
ASSIST™ Registry Protocol 
Rev. AB, 29 March 2019 
NCT03845491 
 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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Sponsor 
Stryker Neurovascular 
47900 Bayside Parkway 
Fremont, CA 94538 
Study Responsibility 
Alice Lin 
Clinical Project Manager 
Stryker Neurovascular 
47900 Bayside Parkway 
Fremont, California 94538-6515 
Email: Alice.Lin@stryker.com 
Coordinating 
Investigators: 
Rishi Gupta, MD 
Director of The Stroke Program at the WellStar Health System 
WellStar Medical Group 
Neurosurgery  
61 Whitcher Street, Suite 3110 
Marietta, GA 30060  
USA 
Email: Rishi.Gupta@Wellstar.org 
Markus A. Möhlenbruch, MD 
Senior Physician Section Manager for Interventional Neuroradiology 
University Hospital Heidelberg 
Im Nuenheimer Feld 400 
69120 Heidelberg 
Germany 
Email: Markus.Moehlenbruch@med.uni-heidelberg.de 
Study Centers 
A current list of sites will be maintained in the Sponsor’s study files 
Date of Issue 
19 April 2018, Rev AA 
Date(s) of Amendment(s) 29 March 2019, Rev AB 
This protocol contains confidential information for use by the Investigators and their designated 
representatives participating in this protocol. It should be held confidential and maintained in a secure 
location. Do not copy or distribute without written permission 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER CORPORATION.                
 
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ASSIST™ Registry Protocol Signature Page 
 
Study Title: 
ASSIST™ Registry 
Study Center: 
 
 
(Print name of study center) 
 
We, the undersigned, have read and understand the protocol specified above and agree on its content. We 
agree to perform and conduct the study as described in the protocol. In addition, when applicable, we agree 
to enlist sub-investigators who also agree to perform and conduct the study as described in the protocol. 
 
 
 
 
 
 
 
 
 
 
Principal Investigator Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name  
 
 
 
 
 
 
 
DD / MMM / YYYY 
 
 
 
 
 
 
 
 
 
 
    
Co-Investigator Signature  □ N/A 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name  
 
 
 
 
 
 
 
DD / MMM / YYYY 
 
 
 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER CORPORATION.                
 
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Clinical Protocol Synopsis 
Primary Objective 
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. 
This Registry will also collect data, including time-to-treatment and quality of 
life measures, to allow for subset analyses that may be used for regulatory 
submissions and/or reimbursement dossiers. 
Primary Clinical 
Outcome 
1. 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 
Secondary Clinical 
Outcomes 
1. Excellent functional outcome defined as mRS of 0-1 at Day 90 (± 14)  
2. 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  
3. Quality of Life at Day 90 (± 14) assessed by EuroQoL (EQ5D5L) 
Primary Procedural 
Outcome 
1. eTICI 2c or greater on first pass as adjudicated by core lab  
Secondary 
Procedural Outcomes 
As adjudicated by core lab:  
1. eTICI 2b50, eTICI 2b67, eTICI 2c, and/or eTICI 3 on first pass, after 
primary technique used, and at the end of the endovascular procedure 
2. Time from groin puncture to eTICI 2b50, eTICI 2b67, eTICI 2c, and/or 
eTICI 3 after first pass  
3. Overall time from groin puncture to achieve eTICI 2c or 3 and final 
reperfusion 
Safety  
Outcomes 
1. All-cause mortality and stroke-related mortality up to 90 Days (±14) 
2. Device and/or procedure related SAEs up to 90 Days (±14) 
3. Neurological deterioration at 24 (-6/+24) hours post procedure defined as a 
NIHSS increase ≥4 points from baseline  
4. Symptomatic intracranial hemorrhage (SICH) adapted from European 
Cooperative Acute Stroke Study (ECASSIII) as any apparent extravascular 
blood in the brain or within the cranium that is associated with clinical 
deterioration defined by a NIHSS increase of four points or more from 
baseline up to 24 (-6/+24) hours 
5. Embolization to New Territory adjudicated by core lab  
Core Lab 
Assessments 
An independent core lab will adjudicate pre and post-procedure non-invasive 
imaging and cerebral angiography to include but not limited to: 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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• 
The Alberta Stroke Program Early CT Score (ASPECTS) 
• 
Collateral Flow Grade 
• 
eTICI Score for Each Pass 
• 
Occlusion Location  
• 
Pre-procedure Perfusion Assessment 
• 
Post-procedure Hemorrhagic Transformation 
• 
Embolization to New Territory (ENT) 
• 
Vessel Size 
Registry Devices 
Data will be collected on the use of Stryker market-released neurovascular 
mechanical access and mechanical thrombectomy devices that are currently 
available or that may be launched during the conduct of the Registry, including 
but not limited to: 
• 
AXS Infinity LS™ Long Sheath (LS)  
• 
AXS Infinity LS™ Plus Long Sheath 
• 
FlowGate2™ Balloon Guide Catheter (BGC) 
• 
Merci® Balloon Guide Catheter 
• 
AXS Catalyst® 5 Distal Access Catheter (DAC) 
• 
AXS Catalyst® 6 Distal Access Catheter 
• 
AXS Catalyst® 7 Distal Access Catheter 
• 
Trevo® Retriever 
• 
AXS Vecta™ 71 Aspiration Catheter (Asp Cath) 
• 
AXS Vecta™ 74 Aspiration Catheter 
• 
Medela Dominant Flex Pump 
Device Sizes 
All product sizes approved for use by the local regulatory agency 
Study Design  
Study Design 
This is a prospective, global, consecutive enrollment Registry of anterior 
circulation acute ischemic stroke patients with a LVO who undergo treatment 
with one of the interventional techniques using Stryker Neurovascular (SNV) 
devices for the first pass. 
Planned Number of 
Subjects 
Up to 1500 subjects 
Planned Number of 
Sites  
Up to 100 sites worldwide 
Study Duration 
Up to 48 months 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER CORPORATION.                
 
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Follow-Up Schedule 
• 
24 (-6/+24) hours post-index stroke procedure 
• 
Discharge/ Day 5-7 (whichever is earlier) 
• 
Day 30 (± 14)  
• 
Day 90 (± 14) 
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 (IFU1): 
Technique Category 
Devices* 
SR Classic 
SR + BGC 
SR Combination 
SR + Asp Cath ± Pump + BGC or LS 
Direct Aspiration  
Asp Cath ± Pump + BGC or LS 
*Defined devices must be SNV market-released products.  
 
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. 
Statistical Methods 
Statistical Test 
Method 
Sample size is estimated based on the desired measurement precision of primary 
clinical and procedural outcomes. General summary and descriptive statistics 
will be used to analyze the study data. Logistic regression will be used to 
evaluate predictors of good outcomes in each of the techniques. Further details 
are provided in the Statistical Analysis Plan (SAP). 
 
 
 
 
 
 
 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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TABLE OF CONTENTS 
1 
Introduction and Rationale ........................................................................................................... 9 
1.1 
Mechanical Thrombectomy Techniques ............................................................................. 9 
1.2 
Triage, Transport and Treatment Times ........................................................................... 10 
1.3 
Quality of Life .................................................................................................................. 10 
1.4 
Importance of ASSIST Registry Data ............................................................................... 11 
2 
Existing Clinical Data .................................................................................................................. 11 
2.1 
TREVO Study ................................................................................................................... 11 
2.2 
TREVO 2 Study ................................................................................................................ 12 
2.3 
MR CLEAN Study ............................................................................................................ 12 
2.4 
TREVO Registry ............................................................................................................... 13 
2.5 
DWI or CTP with Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes 
Undergoing Neurointervention (DAWN™) Trial ............................................................ 13 
3 
Descriptions of Registry Devices ................................................................................................. 14 
3.1 
Registry Devices ............................................................................................................... 14 
3.2 
Device Labeling ................................................................................................................ 14 
4 
Registry Objective ........................................................................................................................ 15 
4.1 
Primary Clinical Outcome ................................................................................................ 15 
4.2 
Secondary Clinical Outcomes ........................................................................................... 15 
4.3 
Primary Procedural Outcomes .......................................................................................... 15 
4.4 
Secondary Procedural Outcomes ...................................................................................... 15 
4.5 
Safety Outcomes ............................................................................................................... 15 
4.6 
Time Points Assessments .................................................................................................. 16 
4.7 
Core Lab Assessments ...................................................................................................... 16 
5 
Registry Design ............................................................................................................................ 16 
5.1 
Sites ................................................................................................................................... 16 
5.2 
Duration ............................................................................................................................ 16 
5.3 
Justification for the Registry Design ................................................................................. 17 
5.4 
Method of Enrollment ....................................................................................................... 17 
6 
Study Population .......................................................................................................................... 17 
6.1 
Selection Criteria .............................................................................................................. 17 
6.1.1 .... Inclusion Criteria ................................................................................................. 17 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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6.1.2 .... Exclusion Criteria ................................................................................................ 18 
6.2 
Withdrawal and Replacement of Subjects ........................................................................ 18 
6.3 
Enrollment Controls .......................................................................................................... 18 
7 
Study Procedures ......................................................................................................................... 18 
7.1 
Written Informed Consent ................................................................................................ 18 
7.2 
Pre-Procedure Assessments .............................................................................................. 18 
7.3 
Procedure/Treatment ......................................................................................................... 19 
7.3.1 .... Angiogram Procedure .......................................................................................... 19 
7.3.2 .... Thrombectomy Procedure .................................................................................... 19 
7.4 
24 hours (-6/+24) Post Procedure ..................................................................................... 21 
7.5 
Discharge/Day 5-7 (whichever is earlier) ......................................................................... 21 
7.5.1 .... Post Discharge Follow Up .................................................................................. 21 
7.6 
Day 30 (±14 days) ............................................................................................................. 22 
7.7 
Day 90 (±14 days) ............................................................................................................. 22 
8 
Statistical Methods ....................................................................................................................... 23 
8.1 
Sample Size Estimate and Justification ............................................................................ 23 
8.2 
Statistical Analysis ............................................................................................................ 24 
9 
Data Management ........................................................................................................................ 24 
9.1 
Data Collection and Processing ........................................................................................ 24 
10 
Monitoring .................................................................................................................................... 25 
11 
Auditing ........................................................................................................................................ 25 
12 
Adverse Events ............................................................................................................................. 25 
12.1 
Adverse Event Definitions and Classification .................................................................. 27 
12.2 
Relationship ...................................................................................................................... 28 
12.3 
Reporting Requirements ................................................................................................... 28 
12.4 
Device Failures, Malfunctions, and Product Nonconformities ......................................... 28 
12.5 
Reporting to Regulatory Authorities / IRBs / ECs Investigators ...................................... 29 
13 
Risk Benefit Analysis ................................................................................................................... 29 
13.1 
Risk Minimization ............................................................................................................ 29 
14 
Steering Committee ..................................................................................................................... 29 
15 
Ethical Considerations................................................................................................................. 30 
15.1 
Compliance with Good Clinical Practices (GCP) ............................................................. 30 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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 Page 8 of 41 
 
 
15.2 
Institutional Review Board / Ethics Committee ............................................................... 30 
15.3 
Protocol Adherence ........................................................................................................... 30 
16 
Study Administration .................................................................................................................. 30 
16.1 
Pre-Study Documentation Requirements .......................................................................... 30 
16.2 
Record Retention .............................................................................................................. 30 
16.3 
Criteria for Suspending/Terminating a Study Center ....................................................... 31 
17 
References ..................................................................................................................................... 32 
18 
Appendices .................................................................................................................................... 35 
Appendix A. 
Abbreviations ....................................................................................................... 35 
Appendix B. 
Definitions ........................................................................................................... 37 
Appendix C. 
Expanded TICI (eTICI) Perfusion Categories ..................................................... 40 
Appendix D. 
Informed Consent Form Template ....................................................................... 41 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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1 
INTRODUCTION AND RATIONALE 
Worldwide, stroke is the leading cause of death for people above the age of 60 and the fifth leading cause in 
people aged 15-59, and is the most common cause of chronic adult disability.2, 3  According to the World 
Health Organization, approximately 15 million people suffer a stroke annually, about 5 million die, and 
another 5 million are permanently disabled as a result. On a global scale, stroke claims a life every ten 
seconds.6  
Over the course of the past few years, treatment for stroke has rapidly evolved with the current 
recommendations including both intravenous tissue plasminogen activator (tPA) and endovascular therapy 
for select patients, based on positive outcomes shown in the five pivotal trials presented in 2014-2015.  Goyal 
et al published the HERMES meta-Analysis which pooled patient-level data to show the additional benefit of 
endovascular thrombectomy in decreasing disability for patients with large vessel anterior circulation 
ischemic stroke irrespective of patient characteristics, geographic location, and eligibility for IV tPA.4 Two 
other-meta analyses evaluated published randomized clinical trials of endovascular therapy versus standard 
of care for treatment of LVO AIS and found that endovascular therapy with mechanical thrombectomy 
resulted in improved functional outcomes for patients compared to standard of care.5,6  
Evidence also supports that reduced time from symptom onset to reperfusion with endovascular therapies is 
associated with better clinical outcomes.  Most clinical studies in recent years have demonstrated that the 
faster the time to recanalization or reperfusion, the better the functional outcome for the patient.7,8,9,10,11 Two 
factors play key roles in determining time to reperfusion: 1) efficiency and effectiveness of mechanical 
thrombectomy techniques, and 2) triage, transport and treatment times. 
1.1 
Mechanical Thrombectomy Techniques 
In the context of AIS, endovascular therapy is often considered a single treatment modality; however, it can 
include a number of different, but related strategies—some of which may be more effective than others.12,13,14 
Common endovascular strategies can include chemical clot dissolution with local delivery of tPA or 
recanalization of arterial occlusion by clot disruption, aspiration, or retrieval using one or more mechanical 
devices. Furthermore, the type of mechanical device used and/or the combination of mechanical devices used 
for endovascular therapy might have a significant influence on reperfusion time and, as a result, functional 
outcome.15,16,17 Although newer retrievable stent devices were used in the more recent clinical trials of 
endovascular therapy, the outcomes of all types of mechanical devices were not recorded in all studies, and 
few studies evaluated the various ways mechanical devices were used in combination to achieve reperfusion. 
The ASSIST Registry is a post-market study, that will focus on the clinical safety and clinical performance 
of Stryker Neurovascular market released access and mechanical thrombectomy devices. The Registry has 
been designed to collect data on subjects who have been treated for acute ischemic stroke due to anterior 
circulation LVO. The Registry will collect data on the following devices  (including but not limited to): the 
AXS Infinity LS Long Sheath, the AXS Infinity LS Plus Long Sheath, the FlowGate2 and Merci Balloon 
Guide Catheters (BGC), the AXS Catalyst Distal Access Catheters (DAC), the AXS Vecta Aspiration 
Catheters,  the Trevo Retriever, and the Dominant Flex Medela pump. 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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 Page 10 of 41 
 
 
Data from subjects treated with the following mechanical thrombectomy techniques will be evaluated. These 
devices will be evaluated in the context of pre-defined mechanical thrombectomy techniques.  
These techniques were chosen to be evaluated based on physician input, current worldwide clinical practice, 
as well as recent scientific studies of adjunctive therapies performed for AIS. For example, the use of a stent 
retriever in combination with a BGC (‘SR Classic’) for the treatment of AIS in the anterior circulation has 
been shown to improve angiographic results and procedure duration time compared to the use of a stent 
retriever alone. 16 Furthermore, several studies have demonstrated that the combination of stent retriever and 
aspiration is safe, fast and effective for first-pass complete reperfusion, 17, 18, 19, 20 and can be more effective 
than the use of a stent retriever alone.18 More data are needed to fully understand the various techniques, 
particularly in relation to safety, effectiveness, and time to reperfusion. This Registry will collect such data 
to help answer these outstanding questions. 
1.2 
Triage, Transport and Treatment Times 
Improvements in triage, transport and treatment times does play a key role in optimizing functional outcomes 
for stroke patients.19,20,21,22,23In all the major endovascular trials to date, it has been convincingly demonstrated 
that longer time to initiation of treatment resulted in a worse clinical outcome. 13,17,18,19,20,28 Door to needle 
times as fast as 20-25 minutes can be achieved with proper planning and infrastructure changes.24 Strict 
adherence to stroke performance metrics like door to needle time, imaging-to-puncture, imaging-to-perfusion 
time and comprehensive metrics like symptom onset to reperfusion time can vastly improve the chances of 
good clinical outcome.25,25,26,27       
For example, in the STRATIS Registry using only Solitaire, the median system of care time was 152 minutes, 
and each hour of delay from this time was associated with a decline in the likelihood of achieving a good 
outcome for the patient.28 In addition, Menon and colleagues (2016) reported that imaging to reperfusion time 
was a significant predictor of outcome in the ESCAPE trial and suggested that inefficiencies in triaging, off-
hour presentation, IV tPA administration (if patient was eligible), use of general anesthesia, and endovascular 
techniques offered major opportunities for improvement in workflow.29 Finally, the guidelines for the early 
management of patients with acute ischemic stroke from the American Heart Association and American 
Stroke Association (2018) strongly recommend streamlined stroke-specific workflows from onset of stroke 
symptoms to reperfusion of the brain, including faster triage, transport, patient evaluation, imaging, 
administration of IV tPA (if patient is eligible), and mechanical thrombectomy techniques.30 
1.3 
Quality of Life 
The ASSIST Registry will include data on quality of life metrics for subjects treated with mechanical 
thrombectomy for ischemic stroke due to anterior circulation LVO. These data will allow evaluation of the 
relationship between mechanical thrombectomy devices and techniques, overall time from symptom onset to 
recanalization or reperfusion, functional outcomes, and subject-reported quality of life. Understanding these 
relationships is a critical aspect in optimizing mechanical thrombectomy devices and techniques as well as 
triage, transport, and treatment times to ensure the best overall quality of life outcome for stroke patients. 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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 Page 11 of 41 
 
 
1.4 
Importance of ASSIST Registry Data 
The ASSIST Registry is a global post-market study designed to assess the procedural success and clinical 
outcomes associated with operator techniques utilizing Stryker Neurovascular Devices used in real-world 
situations across study sites. 
Data collected will include device use and purpose, combinations of devices, mechanical thrombectomy 
techniques, time from onset to triage, triage to transport, transport to treatment, and overall time from onset 
to reperfusion as well as quality of life and other valuable data. By collecting and analyzing this information, 
optimal treatment patterns for select patients can be identified, the critical nature of fastest time possible from 
symptom onset to reperfusion can be demonstrated, time from onset to reperfusion and all critical steps in 
between can be streamlined, and more optimal mechanical thrombectomy techniques and devices can be 
developed.  
The data from the ASSIST Registry will have the potential to help us better understand the functional and 
quality of life outcomes for the millions of individuals around the world who suffer an ischemic stroke each 
year as well as to ease the global burden of this devastating disease. 
2 
EXISTING CLINICAL DATA 
The principal goal in treating acute ischemic stroke is to restore cerebral blood flow as rapidly and safely as 
possible. Five clinical studies, the Thrombectomy REvascularization of large Vessel Occlusions (TREVO) in 
acute ischemic stroke, the TREVO 2 study, the MR CLEAN study, TREVO Registry, and DWI or CTP 
Assessment with Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing 
Neurointervention (DAWN™) Trial were conducted using the Trevo Retriever.  
2.1 
TREVO Study  
The TREVO study was a post marketing prospective, multi-center, single arm study performed at 7 sites in 
Europe designed to quantify the performance of the Trevo Retriever in providing reperfusion and clinical 
benefit to subjects experiencing a large vessel occlusion (LVO) within 8 hours of symptom onset.31 The 
devices used in the study were the Trevo 4 x 20 mm, Trevo Pro 4, and Trevo 3 x 10 mm. 
Sixty (60) subjects were enrolled between February 2010 and August 2011. The primary endpoint was 
angiographic reperfusion as measured by an independent core lab using the TICI scale. Success was defined 
as a final TICI score of 2a or better. Post procedure, successful reperfusion was achieved in 91.7% of subjects. 
In the TREVO study, operators were not restricted from using intra-arterial (IA) lytic, but it was only used in 
10% of cases. 
In regard to secondary endpoints, 55.0% of subjects achieved 90-day good clinical outcomes (mRS of 0-2), 
the 90-day mortality rate was 20.0%, the device-related serious adverse event rate was 5.0% and only 5.0% 
of subjects showed symptomatic intracranial hemorrhage (SICH) at 24 hours.   
The TREVO investigational plan pre-defined specific events that were captured to assess safety which 
included vessel dissection, vessel perforation, intracranial hemorrhage (ICH) (as identified by core lab) and 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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 Page 12 of 41 
 
 
all deaths.  Information for each of these events was collected and then independently adjudicated by the 
Clinical Events Committee (CEC).   
2.2 
TREVO 2 Study  
The TREVO 2 study was an IDE trial designed to support a 510k application for FDA clearance in the U.S.18 
The trial enrolled 178 subjects between February 3, 2011 and December 1, 2011 at 26 sites in the United 
States and one site in Spain. The subjects were randomized 1:1 to Trevo (N=88) or Merci (N=90) and were 
stratified by age and baseline NIHSS to ensure balance in the two arms.  
The primary effectiveness endpoint was post-device reperfusion success defined as at least TICI 2a, which 
was achieved in 86% of patients treated with the Trevo device and 60% of patients treated with the Merci 
device. The primary safety endpoint was a composite of adverse events. The composite rate for the Trevo 
device group was 15% and 23% for the Merci device group.  
Secondary endpoints included time to reperfusion with a mean time for the Trevo group of 47.844.2 minutes 
and 47.338.8 minutes. The 90-day good outcome (mRS 0-2) was 40% for the Trevo group and 22% for the 
Merci group, and the 90-day mortality rate was 33% for Trevo and 24% for Merci. For the Trevo group 7% 
of patients had symptomatic ICH at 24 hours and 16% showed neurological deterioration at 24 hours. For the 
Merci group, 9% had symptomatic ICH at 24 hours and 22% showed neurological deterioration at 24 hours. 
Overall the results of the TREVO and TREVO 2 trials demonstrate reperfusion efficacy and safety of the 
Trevo Retriever. 
2.3 
MR CLEAN Study 
MR CLEAN was a large, prospective, randomized, open label, controlled, multicenter trial in which 16 
centers in the Netherlands participated.32 Subjects with acute ischemic stroke and a proximal intracranial 
arterial occlusion of the anterior circulation that was confirmed on vessel imaging were randomized to intra-
arterial treatment (IAT) plus usual care or usual care alone. The study enrolled 500 subjects at 16 medical 
centers.  A total of 233 subjects were randomized to IAT and 267 subjects to the control group of usual care. 
The primary effectiveness endpoint was to demonstrate that IAT plus usual care leads to superior functional 
independence (mRS ≤2) at 90 days compared to usual care alone. There was a shift in the distribution of the 
primary-outcome scores in favor of the intervention. The adjusted common odds ratio was 1.67 (95% CI, 1.21 
to 2.30). The shift toward better outcomes in favor of the intervention was consistent for all categories of the 
mRS, except for death.  Secondary outcomes included: 1) NIHSS score at 24 hours and at 5-7 days/discharge, 
2) Barthel index, and 3) EuroQol Group 5-Dimension Self-Report Questionnaire at 90 days. The NIHSS score 
after 5 to 7 days was, on average, 2.9 points (95% CI, 1.5 to 4.3) lower in the intervention group than in the 
control group. 
This study showed that IAT in patients with acute ischemic stroke caused by a proximal intracranial occlusion 
of the anterior circulation was effective and safe when administered within 6 hours of stroke onset. 

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2.4 
TREVO Registry 
The Thrombectomy REVascularization of large vessel Occlusion (TREVO) Registry is a Stryker 
Neurovascular Sponsored Registry (data on file) that is a global, multi-center, prospective, open label study. 
The only requirement of the Registry was to have a confirmed LVO and to use the Trevo Retriever as the 
initial mechanical thrombectomy device.  2008 subjects across 100 centers had been treated for ischemic 
stroke with LVO using the Trevo Retriever as the initial mechanical device for thrombectomy. Unlike prior 
randomized trials, this Registry evaluated all clot locations, including M2 (21.0%) and vertebrobasilar 
locations (6.9%).  
Approximately 3/4 of the patients enrolled in the Registry received treatment within 6 hours of symptom 
onset; 1/4 received treatment beyond 6 hours. The mean number of passes with the Trevo Retriever was 1.7, 
with 46.9% of procedures using a balloon guide catheter and 46.6% using an intermediate catheter. The first 
pass TICI 2b/3 reperfusion rate was 62% and the final TICI 2b/3 reperfusion rate was 93% post procedure. 
The 90-day mRS 0-2 was 58.6% in the AHA-like cohort, and over 40% of patients showed improvement in 
NIHSS at 24 hours by 10 points or more. 
Data from the TREVO Registry are in line with the recently published HERMES meta-analysis, 33 
demonstrating generalizability of the Trevo Retriever in a wide range of real world endovascular cases and 
techniques. 
2.5 
DWI or CTP with Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes 
Undergoing Neurointervention (DAWN™) Trial 
DWI or CTP Assessment with Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes 
Undergoing Neurointervention (DAWN™) Trial was a prospective, randomized, multi-center, open-label 
trial with a Bayesian adaptive-enrichment design. Subjects were randomized 1:1 to Trevo thrombectomy plus 
medical management or medical management alone.34  The study enrolled 206 subjects; 107 in the treatment 
arm and 99 in the medical management arm. The trial was stopped early due to the results of a pre-specified 
interim analysis. 
The primary objective was to evaluate the hypothesis that Trevo thrombectomy plus medical management 
leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately 
selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after 
last seen well.  The co-primary endpoints were the mean score for disability on the utility-weighted modified 
Rankin scale (which ranges from 0 [death] to 10 [no symptoms or disability]) and the rate of functional 
independence (a score of 0, 1, or 2 on the modified Rankin scale) at 90 days.  The mean score on the utility-
weighted modified Rankin scale at 90 days was 5.5 in the thrombectomy group as compared with 3.4 in the 
control group (adjusted difference [Bayesian analysis], 2.0 points: 95% credible interval, 1.1 to 3.0; posterior 
probability of superiority, >0.999), and the rate of functional independence at 90 days was 49% in the 
thrombectomy group as compared with 13% in the control group (adjusted difference, 33 percentage points; 
95% credible interval, 24 to 44; posterior probability of superiority, >0.999).  

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The primary safety outcome was incidence of stroke-related mortality at 90 days.  In total, 17% (35/206) of 
the study subjects had stroke-related mortality within 90 days of enrollment into study: 16% (17/107) in the 
Treatment Arm and 18% (18/99) in the Control Arm. Stroke-related mortality rates at 90 days did not differ 
significantly (p= 0.7126) between study arms. 
The study concluded that among patients with acute stroke who had last been known to be well 6 to 24 hours 
earlier and who had a mismatch between clinical deficit and infarct, outcomes for disability at 90 days were 
better with thrombectomy plus standard care than with standard care alone.  
3 
DESCRIPTIONS OF REGISTRY DEVICES 
Stryker market-released neurovascular access and mechanical thrombectomy devices that are currently 
available or that may be launched during the conduct of the Registry may be included in the ASSIST Registry.  
Refer to the approved regional Instructions for Use (IFU) for detailed instructions for use, warnings, and 
precautions.  
3.1 
Registry Devices 
Data will be collected on the use of any Stryker market-released neurovascular access and mechanical 
thrombectomy devices using the pre-defined registry techniques that are currently available or that may be 
commercialized during the conduct of the Registry, including but not limited to: 
• 
AXS Infinity LS™ Long Sheath (LS)  
• 
AXS Infinity LS™ Plus Long Sheath 
• 
FlowGate2™ Balloon Guide Catheter (BGC) 
• 
Merci® Balloon Guide Catheter 
• 
AXS Catalyst® 5 Distal Access Catheter 
• 
AXS Catalyst® 6 Distal Access Catheter 
• 
AXS Catalyst® 7 Distal Access Catheter 
• 
Trevo® Retriever 
• 
AXS Vecta™ 71 Aspiration Catheter (Asp Cath) 
• 
AXS Vecta™ 74 Aspiration Catheter 
• 
Medela Dominant Flex Pump 
All product sizes approved for use by the local regulatory agency can be used. 
3.2 
Device Labeling 
A copy of the device IFU is included in each device package. Device labels and labeling generally contain 
the following information as relevant:  
• 
Device dimensions 
• 
Lot number 
• 
Expiration (use before) date 
• 
Compatibility information 

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4 
REGISTRY OBJECTIVE 
The purpose of this Registry is to assess the procedural success and clinical outcomes associated with various 
operator techniques for mechanical thrombectomy in LVO in the anterior circulation. 
This Registry will also collect data, including time-to-treatment and quality of life measures, to allow for 
subset analyses that may be used for regulatory submissions and/or reimbursement dossiers. 
4.1 
Primary Clinical Outcome 
1. Severity of disability at Day 90 (±14) assessed by mRS with a good functional outcome defined 
as mRS of 0-2 for each technique 
4.2 
Secondary Clinical Outcomes 
1. Excellent functional outcome defined as mRS 0-1 at Day 90 (±14) 
2. 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  
3. Quality of Life at Day 90 (14 days) assessed by EuroQoL (EQ5D5L) 
4.3 
Primary Procedural Outcomes 
1. eTICI 2c or greater on first pass as adjudicated by core lab 
4.4 
Secondary Procedural Outcomes 
As adjudicated by core lab: 
1. 
eTICI 2b50, eTICI 2b67, eTICI 2c, and/or eTICI 3 on first pass, after primary technique used, and 
at the end of the endovascular procedure 
2. 
Time from groin puncture to eTICI 2b50, eTICI 2b67, eTICI 2c, and/or eTICI 3 after first pass  
3. 
Overall time from groin puncture to achieve eTICI 2c or 3 and final reperfusion 
4.5 
Safety Outcomes 
1. All-cause mortality and stroke-related mortality up to Day 90 (±14) 
2. Device and/or procedure related SAEs up to Day 90 (±14) 
3. Neurological deterioration at 24 (-6/+24) hours post procedure defined as a four or more point 
increase in NIHSS from baseline  
4. Symptomatic intracranial hemorrhage (SICH) adapted from European Cooperative Acute Stroke 
Study (ECASSIII) as any apparent extravascular blood in the brain or within the cranium that is 
associated with clinical deterioration defined by a NIHSS increase of four points or more from 
baseline up to 24 (-6/+24) hours 
5. Embolization to New Territory adjudicated by core lab 
 
 

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4.6 
Time Points Assessments  
The ASSIST Registry will collect data on workflow and procedural information including types of 
techniques, thrombus location, tandem lesions, and procedure and imaging measurements, along with time 
specific data points including: 
• 
Last Time Known Well (LTKW) 
• 
First Medical Contact (i.e. 911, Emergency Medical Service) 
• 
Time of Departure from First Hospital if applicable 
• 
Time of Arrival at Treating Hospital 
• 
Time of Arrival at Angiography Suite 
• 
Time of Groin Puncture (Time Skin Punctured by Needle) 
• 
Time of Completion of First Pass 
• 
Time of Reperfusion for eTICI 2b50, eTICI 2b67, eTICI 2c, and/or eTICI 3 after First Pass 
• 
Overall Time to eTICI 2c or 3 
• 
Overall Time of Final Reperfusion 
4.7 
Core Lab Assessments 
An independent core lab will adjudicate pre and post procedure non-invasive imaging and cerebral 
angiography to include but not limited to: 
• 
The Alberta Stroke Program Early CT Score (ASPECTS) 
• 
Collateral Flow Grade  
• 
eTICI Score for Each Pass 
• 
Occlusion Location  
• 
Pre-procedure Perfusion Assessment  
• 
Post-procedure Hemorrhagic Transformation 
• 
Embolization to New Territory (ENT) 
• 
Vessel Size 
5 
REGISTRY DESIGN 
This is a prospective, global, consecutive enrollment Registry of anterior circulation acute ischemic stroke 
patients with a LVO who undergo treatment with one of the interventional techniques using SNV devices for 
the first pass. 
5.1 
Sites 
The Registry will enroll up to 1500 subjects and will be conducted at up to 100 sites worldwide. The Registry 
devices will have regulatory authorization to be on the market in the geographic location of all sites. 
5.2 
Duration 
The duration of the Registry protocol is approximately 48 months. 

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5.3 
Justification for the Registry Design 
The intent of the ASSIST Registry is to collect global data to help compare treatment techniques and promote 
the criticality of time assessment.  Physicians and manufacturers will gain access to valuable information for 
ongoing improvement in the development of devices focused on the treatment of AIS and for the evaluation 
of the optimal treatment technique.  A new study is required to specifically assess the performance of Stryker 
products utilizing one of the interventional techniques.  The objective of prior studies has focused on safety 
and effectiveness of Trevo Stent Retriever, and there is limited real-world data regarding treatment techniques 
that utilize other Stryker Neurovascular devices. 
5.4 
Method of Enrollment 
This Registry has open consecutive enrollment. Clinical data points will be evaluated in all subjects who meet 
the inclusion/exclusion criteria. 
Screening and enrollment information will be maintained electronically in the Electronic Data Capture (EDC) 
by each site to document basic information such as date screened and reason for screen failures for subjects 
who fail to meet the study eligibility criteria.  To avoid bias, if a center chooses to participate in the ASSIST 
Registry, every effort should be made to include all thrombectomy cases that follow one of the techniques 
that use Stryker Neurovascular products performed over a given duration of time in the Registry.  
6 
STUDY POPULATION 
6.1 
Selection Criteria 
6.1.1 
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). 
Table 1. Thrombectomy Techniques to be Evaluated in the ASSIST Registry 
Technique Category 
Devices* 
SR Classic 
SR + BGC 
SR Combination 
SR + Asp Cath ± Pump + BGC or LS 
Direct Aspiration  
Asp Cath ± Pump + BGC or LS 
*Defined devices must be SNV market-released products. 
 

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6.1.2 
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. 
6.2 
Withdrawal and Replacement of Subjects 
While study withdrawal is discouraged, subjects may withdraw from the study at any time, with or without 
reason and without prejudice to further treatment. Withdrawn subjects will not undergo any additional follow-
up, nor will they be replaced. If a subject chooses to withdraw from the Registry, the reason(s) for withdrawal 
will be recorded on the appropriate electronic Case Report Form (eCRF) and in the medical record.  
6.3 
Enrollment Controls 
Enrollment will be monitored to ensure that no more than the specified number of subjects is enrolled. The 
EDC System will be used and monitored to ensure maximum enrollment is contained. 
7 
STUDY PROCEDURES 
7.1 
Written Informed Consent  
An Informed Consent Form (ICF) template is provided in Appendix D for the Investigator to prepare for 
Institutional Review Board (IRB)/Ethics Committee (EC) submission. The ICF must be prepared in the 
language(s) of the potential subject population, document version identified, and approved by the site 
IRB/EC.  A copy must be provided to Stryker Neurovascular. Modifications to the form must be approved by 
Stryker Neurovascular prior to implementation.  
An ICF  must be obtained pre-procedure or up to 48 hours post- procedure.  The ICF must be obtained prior 
to data entry into the ASSIST Registry EDC. The subject or the subject’s legally authorized representative 
(LAR) will be asked to sign the ICF. Study personnel should document the consent process in the subject’s 
medical record per Good Clinical Practice (GCP). The subject or LAR is to be provided a copy of the signed 
ICF. 
7.2 
Pre-Procedure Assessments 
The following pre-procedure data will be obtained for subjects enrolled in the Registry: 
• 
Inclusion/Exclusion Criteria 
• 
Informed Consent 
• 
Demographics & Medical History 
• 
Baseline Labs 
• 
Baseline Pre-stroke mRS  
• 
Post-stroke NIHSS assessment 
• 
Stroke Onset 
• 
Neuroimaging (CT, MR) 

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7.3 
Procedure/Treatment 
7.3.1 
Angiogram Procedure 
For subjects enrolled in this Registry, treatment initiation will be defined as the date and time of groin 
puncture. 
A diagnostic angiogram must be performed to determine the appropriate procedural technique to be used for 
reperfusion. The following will be collected for subjects enrolled in the Registry:  
• 
The occlusion location(s)  
• 
A single image when all devices are in position for each pass.  This will be the start time of the pass.  
Please note: A single image must be performed, even if there is failure to access the clot. 
• 
Angiographic evaluations with clear visualization of the target artery before treatment initiation, after 
each attempt to remove thrombus from the occlusion location, and post-procedure to determine vessel 
patency. It is considered best practice to utilize the same angiographic orientation before and after 
device use as well as post-procedure and to include late venous phase in the angiogram acquisition 
to allow a valid analysis of the reperfusion status of the vessel(s). 
• 
Expanded TICI scores for each pass within the vascular territory being treated.  Time of eTICI 
assessment will be the stop time of each pass. 
Sites will submit all de-identified angiographic data for subjects enrolled in the Registry, rather than pre-
selecting a subset of images. If angiographic images are missing from the sequence of acquisitions, the core 
lab will request the site to resend the de-identified angiography dataset. 
In the event of a procedural complication or adverse event, detailed angiographic images shall be obtained 
and submitted. All adverse events and/or device malfunctions that occur during the procedure must be 
documented and recorded on the applicable CRFs. 
7.3.2 
Thrombectomy Procedure 
The thrombectomy techniques that will be evaluated in the ASSIST Registry are included in Table 2. 
Additionally, Table 3 includes examples of SNV devices that can be used for each technique. Note that not 
all devices in Table 3 have market approval in all global regions for the intended use as described in Table 2. 
Physicians should use each device according to the intended use statement in the most current version of the 
IFU with regards to the devices’ intended use, compatibility, preparation and the recommended retrieval 
procedure. 
 
 

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Table 2. Procedural Techniques Evaluated in the ASSIST Registry 
Technique 
Description 
SR Classic  
Definition: Referred to as the “SR Classic” technique which combines a BGC for 
proximal flow control and retrieval with the Trevo Retriever.   
Procedural technique: The BGC is placed at the desired location. Using a guide 
wire, a microcatheter is then navigated through the BGC to the site of occlusion. 
Position the microcatheter tip distal to the thrombus and remove the guidewire. The 
retriever is delivered through the microcatheter and is deployed per IFU and is 
allowed to expand and integrate into the clot. Prior to retriever retraction, the BGC 
is inflated (to control antegrade flow in the ICA).  During retrieval, it is 
recommended that aspiration is applied through the BGC per the Trevo IFU. 
SR Combination 
Definition: Referred to as the “SR Combination” technique which involves using 
distal aspiration applied at the clot in conjunction with proximal flow control and a 
stent retriever.  
Procedural technique: The BGC or LS is placed at the desired location. Using a 
guide wire, the aspiration catheter and microcatheter are navigated to the site of the 
occlusion – the aspiration catheter may be left proximal to the occlusion until 
retrieval begins. Position the microcatheter tip distal to the thrombus and remove 
the guidewire. The retriever is delivered through the microcatheter and is deployed 
per IFU. The retriever is allowed to expand and integrate into the clot and 
microcatheter is removed. [For BGC Only: Prior to retriever retraction, the BGC 
is inflated (to control antegrade flow in the ICA).] Aspiration is initiated and the 
aspiration catheter is navigated proximal to the clot. Aspiration is applied through 
the aspiration catheter and when there is no blood flow it has engaged the 
thrombus. The retriever and aspiration catheter are retracted together with care 
being taken not to bring the retriever all the way into the aspiration catheter.   
Direct 
Aspiration 
Definition: Referred to as the “Direct Aspiration” technique which involves 
aspiration through the aspiration catheter. 
Procedural technique: The BGC or LS is placed at the desired location. Using a 
guidewire, the aspiration catheter is navigated to the occlusion using the appropriate 
delivery catheter. Before aspiration, remove the delivery catheter and guidewire. 
Aspiration is applied through the aspiration catheter.   
 
 
 

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Table 3. Examples of Technique Products 
Technique Category 
Technique 
Products  
SR Classic 
1 
SR (Trevo) + BGC (FlowGate2 or Merci) 
SR Combination 
2 
SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS 
Infinity LS, AXS Infinity LS Plus) 
3 
SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or 
Merci) 
Direct Aspiration  
4 
Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS 
Infinity LS Plus) 
5 
Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci) 
Note: Additional SNV products that are commercialized during the conduct of the Registry may also be 
included.  
7.4 
24 hours (-6/+24) Post Procedure 
The following data will be collected at 24 hours (-6/+24) post procedure: 
• 
NIHSS  
• 
Imaging (CT, MR) 
• 
Device and/or Procedure Related AEs  
• 
All SAEs  
• 
All Deaths  
Any death or device and/or procedure related AEs and all SAEs should be reported to Stryker Neurovascular 
within 24 hours of becoming aware by eCRF completion. Available information regarding the primary cause 
of death and date/time of death will be recorded.  
7.5 
Discharge/Day 5-7 (whichever is earlier) 
A subject may be discharged from the hospital at the Investigator’s discretion. The following data will be 
collected between Day 5-7 (if subject remains in the hospital) or at discharge, whichever occurs first: 
• 
mRS  
• 
NIHSS  
• 
Device and/or Procedure Related AEs  
• 
All SAEs 
• 
All Deaths 
Any death or device and/or procedure related AEs and all SAEs should be reported to Stryker Neurovascular 
within 24 hours of becoming aware by eCRF completion. Available information regarding the primary cause 
of death and date/time of death will be recorded.  
7.5.1 
Post Discharge Follow Up 
The designated staff at the clinical site will review the follow-up schedule with the subject to maximize 
compliance. The staff will instruct subjects to return for follow-up assessments according to the study Time 

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and Events Schedule in Table 4. Study staff should establish a date for the follow-up visits with the subject 
and if possible, schedule the visits at the time of hospital discharge. 
The study will be considered complete after all subjects have completed the Day 90 (± 14) follow-up 
assessments or have discontinued the study early. Requirements of each follow-up evaluation are detailed 
below. 
7.6 
Day 30 (±14 days) 
At Day 30 (± 14 days) the following study assessments should be performed:  
• 
mRS (A telephone assessment may be conducted, but in-person is strongly encouraged) 
• 
Device and/or Procedure Related AEs 
• 
All SAEs 
• 
All Deaths 
 
Any death or device and/or procedure related AEs and all SAEs should be reported to Stryker Neurovascular 
within 24 hours of becoming aware. For all subjects who expire prior to the Day 30 assessment, available 
information regarding the primary cause of death and date/time of death will be recorded.  
7.7 
Day 90 (±14 days) 
At Day 90 (± 14 days) the following study assessments should be performed:  
• 
mRS (A telephone assessment may be conducted, but in-person is strongly encouraged) 
• 
EuroQol (EQ5D5L)  
• 
Device and/or Procedure Related AEs  
• 
All SAEs 
• 
All Deaths  
Any death or device and/or procedure related AEs and all SAEs should be reported to Stryker Neurovascular 
within 24 hours of becoming aware. For all subjects who expire prior to the Day 90 assessment, available 
information regarding the primary cause of death and date/time of death will be recorded. 
 
 
 

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Table 4. Time and Events Schedule  
Time and Events Schedule 
Assessments: 
Pre-
procedure 
(Screening 
/Baseline) 
Procedure 
24 (-6/+24) 
hrs. post 
procedure 
Discharge 
(or Day 5-7 
whichever 
comes first) 
Day 30 
±14 days 
Day 90 
±14 days 
Inclusion/Exclusion 
Criteria 
 
 
 
 
 
 
Informed Consent* 
 
 
 
 
 
 
Demographics & 
Medical History 
 
 
 
 
 
 
Baseline Labs   
 
 
 
 
 
 
mRS** 
 
 
 
 
 
 
NIHSS Assessment 
 
 
 
 
 
 
EuroQol (EQ5D5L) 
 
 
 
 
 
 
Stroke Onset 
 
 
 
 
 
 
CT/MRﻻ  
 
 
 
 
 
 
Angiogram Procedure 
Information ‡***ﻻ  
 
 
 
 
 
 
Hospital 
Stay/Discharge 
Disposition**** 
 
 
 
 
 
 
Adverse Events‡ 
 
 
 
 
 
 
Study Completion 
 
 
 
 
 
 
*Written Informed Consent must be obtained prior to subject enrollment and any data entry.  
**Telephone mRS assessment is acceptable if subject is not able to return in person.  
***See study binder for worksheets listing items to record during the procedure.  
****Study Staff should review the study requirements with the subject and arrange all follow-up visits at 
discharge. 
‡ All AEs during procedure, only Device Related and/or Procedure Related AE & all SAE, death post 
procedure. 
ﻻ CT/MR and Angiographic images will be de-identified with subject ID# if submitted to SNV or the core 
lab. 
8 
STATISTICAL METHODS 
8.1 
Sample Size Estimate and Justification 
The sample size of ASSIST is based on the precision of the estimate of functional independence (90-day mRS 
0-2) in a real-world setting. The TREVO Registry had an observed rate of 55.3% with a 95% CI of [53.1, 
57.4] for functional independence and the rate is similar to that reported in a pooled analysis of 5 RCT 
thrombectomy trials (46.0%)7. Given the uncertainty of outcomes of some of the procedural techniques a rate 
of 50% functional independence was assumed for this study with a precision of 6%.  With a 95% Wald 

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STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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confidence interval of [47%, 53%], a sample size of 1200 observes such precision inference with a probability 
> 0.9. A 20% loss to follow-up increases the total sample size to 1200/0.8 = 1500. 
There may not be uniform recruitment of patients to each technique group. Thus, a maximum of 5 groups was 
used to calculate the minimum and maximum sample size per group, given that additional techniques and 
commercialized devices may be added during the conduct of the study. Assuming a minimum group size of 
72 and a total enrollment of 1500, the maximum enrollment in any technique group is (1500 – 72) / 4 = 357.   
The overall sample size as well as minimum and maximum enrollment per technique provides sufficient 
sample size to provide precise estimates of the study endpoints in each of the procedural techniques.  
8.2 
Statistical Analysis 
Day 90 outcomes will be compared to pre-stroke mRS status, baseline imaging and time of symptom onset 
to treatment.  Interim analysis will be performed periodically, and the results will be reported. Additional 
interim analyses and data reporting will occur throughout the study enrollment period. 
Sub-group analyses for the Registry will be performed under guidance from the Study PIs, Steering 
Committee, and Sponsor. 
General summary and descriptive statistics will be used to analyze the data. For each binary and categorical 
variable, procedural success, the point estimate, percentage, and its exact 95% confidence interval will be 
provided. For continuous variables, total sample size, mean, standard deviation, median, minimum, and 
maximum will be provided. 
Logistic regression will be used to evaluate predictors of good outcomes in each of the techniques. 
Further details will be provided in the SAP. 
All statistical analyses will be performed using SAS version 9.4 or above. (Copyright © 2002-2008 by SAS 
Institute Inc., Cary, North Carolina, USA, all rights reserved)  
9 
DATA MANAGEMENT 
9.1 
Data Collection and Processing 
Data will be collected in a secure, password protected electronic data capture (EDC) system, which is 
accessible via the Internet.  All pertinent data will be entered by trained study center personnel into the 
electronic Case Report Forms (eCRFs).  A unique subject ID number will be assigned to each subject 
enrolled.  Every reasonable effort should be made to complete data entry within one week of data collection. 
Any data discrepancies may be queried during ongoing review of data by the sponsor or may be identified 
and queried during the routine remote monitoring process.  Remote monitoring may be performed to verify 
data accuracy and ensure queries are resolved. The Principal Investigator must ensure the accuracy and 
completeness of the recorded data and provide his/her electronic signature on the appropriate eCRF. 
If images are sent to a Core Lab, the results may also be entered into the EDC system and electronically 
signed by the reviewer responsible for entering this data. Ongoing data review will be performed to identify 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER CORPORATION.                
 
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possible data discrepancies. Manual and/or automatic queries will be created in the EDC system and will be 
issued to Core Lab for appropriate resolution.   
10 MONITORING 
Stryker Neurovascular will assess each participating site to assure that the Investigator(s) understand the 
protocol, as well as their obligations to conduct the Registry in accordance with applicable Regulations, 
GCP’s and the Registry protocol. The monitor will also confirm that the Investigator has an adequate subject 
population, facilities, personnel and time to conduct the Registry properly.  While the Sponsor intends to use 
remote monitoring methods, periodic on-site monitoring visits will be made to confirm that the site remains 
compliant with the protocol, applicable regulations, GCP and that all agreed-upon activities are carried out 
by the Investigator and other specified staff members.   
Data will be monitored on-site and/or remotely for completeness and logical consistency. De-identified 
procedure summary and ASSIST Registry worksheets sent to Stryker Neurovascular must have the subject 
identification number recorded on any forms. The procedure documents for each subject enrolled may be 
compared against the eCRFs to ensure consistency. 
It is important that the Investigator and relevant study site personnel are available during monitoring visits 
and that sufficient time is devoted to the process. In order to perform her or his role well, the monitor must 
be given access to primary subject medical records which support the Registry eCRFs. This access must be 
disclosed to the subject via the informed consent. 
11 AUDITING  
Sites may be subject to a quality assurance audit by Stryker Neurovascular or its designees, or other regulatory 
authorities. 
12 ADVERSE EVENTS 
An Adverse Event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical sign (including abnormal laboratory findings) in subjects, users or persons, whether or not related to 
the medical device(s). All subjects will be assessed for complications or adverse events during the procedure 
and at all follow-up visits per section 7.4-7.7, and recorded on the AE case report form. Data to be collected 
will include the AE event term, onset and resolution dates (or whether the AE is ongoing), seriousness, 
management/treatment, outcome, and determination of the relationship to the devices and the index 
procedure. All AEs will be followed until resolution or an appropriate endpoint is reached, or until the subject 
has completed or discontinued the registry. 
More specifically, the following adverse events are to be reported on the Adverse Event case report form:  
• 
All AEs and serious adverse events (SAE) that occur during the procedure  
• 
Only device and/or procedure related AEs post procedure through Day 90 
• 
All SAEs post procedure through Day 90  

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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NOTE: Any “prolonged” hospitalization(s) related to the study procedure which is considered 
standard of care due to subject age, co-morbidities or neurological status at presentation will not be 
considered SAEs 
• 
Any event causing neurological deterioration defined as a ≥ 4 point increase on the NIHSS from baseline 
(e.g. cerebral edema, brain herniation, stroke progression) which is related to the index stroke 
• 
Any event causing symptomatic intracranial hemorrhage (SICH) defined as a ≥ 4 point increase in NIHSS 
from baseline for which the hemorrhage is determined to be the cause 
• 
All device-related adverse events (also known as “adverse device effects” [ADEs]) 
• 
All serious adverse device effects (SADEs) 
• 
All unanticipated serious adverse device effects (USADEs) 
• 
All adverse events that result in death through Day 90 
NOTE:  Death should not be recorded as the AE term but should be reflected as an outcome to a 
specific AE 
Pre-treatment findings and pre-existing medical conditions will not be reported as AEs unless there is an 
increase in their frequency or severity during the course of the registry. Elective/planned hospitalization after 
enrollment in the Registry will not be regarded as an AE or a SAE. However, AEs that may occur during 
elective hospitalization, and are unrelated to the elective hospitalization should be evaluated and recorded 
appropriately.  
 
 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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12.1 Adverse Event Definitions and Classification 
Term 
Definition 
Reference 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
a subject, users or other persons, whether or not related to the 
investigational medical device 
ISO 
14155:2011 
Adverse Device 
Effect (ADE)  
Any adverse event related to the use of a medical device.  
Note 1: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of the 
device.  
Note 2: This definition includes any event resulting from use error 
or intentional misuse of the device  
ISO 
14155:2011 
Serious Adverse 
Event (SAE) 
An adverse event that:  
• led to death, or 
• resulted in a life-threatening illness or injury, or 
• resulted in a permanent impairment of a body structure or a body 
function, or 
• required in-patient or prolonged hospitalization, or  
• resulted in medical or surgical intervention to prevent life-
threatening illness or injury or permanent impairment to body 
structure or a body function, or 
• led to fetal distress, fetal death or a congenital abnormality or 
birth defect 
NOTE:  Planned hospitalization for a pre-existing condition, or a 
procedure required by the protocol, without serious deterioration in 
health, is not considered a SAE 
ISO 
14155:2011 
Serious Adverse 
Device Effect 
(SADE) 
An adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event  
ISO 
14155:2011 
Unanticipated 
Serious Adverse 
Device Effect 
(USADE)  
Serious adverse device effect which by its nature, incidence, 
severity or outcome has not been identified in the current version 
of the risk analysis report  
ISO 
14155:2011 
 
 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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12.2 Relationship 
The Investigator must assess the relationship of the AE to each Stryker Neurovascular device using the 
following criteria categories and definitions: 
• 
Unrelated - The AE is due to a concurrent illness or effect of another device/drug and is not related to the 
study device. 
• 
Related - The AE is due to the study device (possible, probable, or highly probable).  
All AEs that are related to a Stryker device will be reported to the Stryker Neurovascular Complaint 
Management Center prompting a further investigation. Sites will be contacted for more detailed information.  
The Investigator must assess the relationship of the AE to the index procedure using the following categories 
and definitions: 
• 
Unrelated - The AE is due to a concurrent illness or effect of a drug and is not related to the index 
procedure. 
• 
Related - The AE is due to the index procedure (possible, probable, or highly probable).  
12.3 Reporting Requirements 
Any death or device and/or procedure related AEs and all SAEs should be reported within 24 hours of 
becoming aware to Stryker Neurovascular via data entry into the eCRFs.  If access to eCRFs is not available, 
then the information can be emailed to ASSISTRegistry@Stryker.com. 
12.4 Device Failures, Malfunctions, and Product Nonconformities 
All Stryker Neurovascular product failures, malfunctions and product nonconformities will be documented 
on the appropriate eCRF, and the involved device(s) should be returned to Stryker Neurovascular for analysis 
if possible. Assistance with returning the study device(s) can be provided by contacting your local Customer 
Service Center. Contact information for Customer Service Centers is located in the Regulatory Binder. Device 
failures and malfunctions should also be documented in the subject’s medical record. 
All Stryker Neurovascular device failures, malfunctions and product nonconformities should be reported 
within 24 hours of becoming aware to Stryker Neurovascular via data entry into the eCRFs. If access to 
eCRFs is not available, then the information can be emailed to ASSISTRegistry@Stryker.com. 
NOTE: Stryker Neurovascular device failures, malfunctions and product nonconformities should be 
reported as soon as possible after becoming aware of them and are not to be reported as adverse events. 
However, if there is an adverse event that results from a device failure or malfunction, that specific event 
would be recorded on the appropriate eCRF.   All Stryker device failures, malfunctions, product 
nonconformities and resulting AEs are reported to the Stryker Neurovascular Complaint Management 
Center prompting a further investigation. Sites will be contacted for more detailed information.  

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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12.5 Reporting to Regulatory Authorities / IRBs / ECs Investigators 
Stryker Neurovascular is responsible for reporting adverse event information to all participating Investigators 
and regulatory authorities, as applicable.   
Any adverse event associated with the use of Stryker Neurovascular products will be reported in accordance 
with the European Medical Device Directive MDD 93/42/EEC and MEDDEV 2.12-1 Guidelines on a 
Medical Device Vigilance System, and local regulatory requirements. 
The Site PI is responsible for informing the IRB/EC of any events as required by local procedure. A copy of 
this report may be requested by Stryker Neurovascular. 
13 RISK BENEFIT ANALYSIS  
The risks associated with this study are limited to a possibility that confidential patient information may be 
disclosed.  It is possible that subjects enrolled into the ASSIST Registry will receive no direct benefit from 
participation.  Possible benefits of the Registry include providing information regarding the use of the 
procedural techniques that involve Stryker Neurovascular study devices; (i.e.the AXS family of products, the 
FlowGate2 and Merci Balloon Guide Catheters, Trevo Retriever, and the Medela Dominant Flex Pump) that 
may benefit future patients, as well as a better understanding of Quality of Life after a thrombectomy 
procedure. 
13.1 Risk Minimization  
In order to minimize risks, Stryker Neurovascular will carefully select study sites and Investigators who have 
experience with neuro-interventional procedures.  Thorough training on the protocol, IFU and Registry 
requirements will be conducted and Stryker Neurovascular will be available to address any Registry specific 
issues or questions. Reasonable measures will be taken to minimize any risk of loss of confidentiality 
including the use of subject ID numbers for data entry and de-identification of any images or records sent to 
the core-lab or Stryker. A Steering Committee will assist in oversight of the ASSIST Registry. Safety 
monitoring of the data will be continuous throughout the Registry.   
14 STEERING COMMITTEE 
The ASSIST Registry Global Steering Committee will include the ASSIST Registry Global PIs and up to 12 
members. Responsibilities may include oversight of the overall conduct of the study with regard to protocol 
development, study progress, subject safety, overall data quality and integrity, as well as disseminating any 
study results through appropriate scientific sessions and publications. Steering Committee members may 
participate in the review and approval of all requests for data analysis, abstract and manuscript preparation 
and submission.  

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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15 ETHICAL CONSIDERATIONS 
15.1 Compliance with Good Clinical Practices (GCP) 
The Investigator will ensure that this study is conducted in accordance with the ethical principles that have 
their origins in the Declaration of Helsinki and that are consistent with GCP and applicable regulatory (local) 
requirements; whichever affords the greater protection to the subject. 
15.2 Institutional Review Board / Ethics Committee  
A copy of the protocol, proposed ICF, other written subject information, and any proposed advertising 
material (if applicable) must be submitted to the IRB/EC for written approval. A copy of the written IRB/EC 
initial approval of the protocol and ICF must be received by Stryker Neurovascular before recruitment of 
subjects into the ASSIST Registry.  Approval from the IRB/EC for all subsequent protocol amendments and 
changes to the ICF must be on file with Stryker. Investigational sites must notify the IRB/EC of any events 
per local regulations. 
15.3 Protocol Adherence 
Prior to beginning the study, the Investigator must sign the Investigator Agreement agreeing to conduct the 
study in accordance with the protocol. An Investigator must not make any changes or deviate from this 
protocol, except to protect the life and physical well-being of a subject in an emergency. 
Stryker Neurovascular will ensure that this study is conducted in compliance with GCPs and all applicable 
regulatory requirements.  
16 STUDY ADMINISTRATION 
16.1 Pre-Study Documentation Requirements 
Prior to enrolling any subjects into the Registry, the site must complete all pre-study essential documents, and 
these must be confirmed to be on file with the Stryker Neurovascular, including but not limited to: CV, 
medical license, W-8 or W-9 (where applicable), signed clinical trial agreement, IRB/EC approval of the 
study and the Informed Consent and all required study training. A site initiation visit will be conducted prior 
to authorization to enroll. No site may begin enrolling subjects until they receive written approval from 
Stryker Neurovascular.  
16.2 Record Retention 
The Investigator will maintain all essential Registry documents and source documentation, in original format, 
that support the data collected on the study subjects in the event that the data is necessary for regulatory 
submission. Documents must be retained for 2 years or longer per local governing regulatory guidelines. 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
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STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
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16.3 Criteria for Suspending/Terminating a Study Center 
Stryker Neurovascular reserves the right to stop or suspend a study center at any time after site authorization 
to enroll if no subjects have been enrolled within 6 months, or if there are concerns with data integrity. 
 
 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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17 REFERENCES
1. SNV Product IFU: https://www.strykerneurovascular.com/us/products/access 
 
2.  CDC. Stroke Facts. Sep 2017; Available from: http://www.cdc.gov/stroke.facts.htm. 
3.  http://www.worldstrokecampaign.org/learn/facts-and-figures.html. 
4.  Goyal M, Menon BK, Zwam WH, et al.; Endovascular thrombectomy after large-vessel ischaemic 
stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016; p 1723-31. 
https://doi.org/10.1016/S0140-6736(16)00163-X. 
5.  Kennedy SA, Baerlocher MO, et al.; Meta-Analysis of Local Endovascular Therapy for Acute Ischemic 
Stroke, J Vasc Interv Radiol.; 2016 Mar; p 307-21. 
6. Badhiwala JH, Nassiri F; Endovascular Thrombectomy for Acute Ischemic Stroke: A Meta-analysis; 
JAMA; 2015 Nov 3; p 1832-43. 
7.  Doerr M, et.al; Evaluation of Strategies to Reduce Time to Revascularization in Acute Ischemic Stroke;  
International Stroke Conference Poster Abstract; Stroke 2017; 48:AWP411. 
8.  Darazanli C, Consoli A, Labreuche J, et al.; Impact of Modified TICI 3 versus 2b Reperfusion Score to 
Predict Good Outcome following Endovascular Therapy; AJNR Am J Neuroradiol. 2017 Jan; p 90-96. 
9.  Appireddy RM, Demchuk AM, Goyal M, et al.; Endovascular Therapy for Ischemic Stroke; J Clin Neurol.; 
2015 Jan; p 1-8. 
10. Goyal M, Demchuk AM, Menon BK, et al; ESCAPE Trial Investigators Randomized assessment of rapid 
endovascular treatment of ischemic stroke. N Engl J Med 2015; p 1019 –30 CrossRef Medline. 
11.  Turk 2014 AS, Turner R, Spiotta A, et al.; Comparison of Endovascular Treatment Approaches for Acute 
Ischemic Stroke: Cost Effectiveness, Technical Success, and Clinical Outcomes; J Neurointerv Surg. 2015 
Sep; p 666-70; doi 10.1136/neurintsurg-2014-01182. Epub 2014 Jul 15; PMID: 25028502. 
12 . Gupta R, Vora A, Horowitz M, et al.; Multimodal Reperfusion Therapy for Acute Ischemic Stroke 
Factors 
Predicting 
Vessel 
Recanalization; 
Stroke. 
2006; 
p 
986-990; 
DOI: 
10.1161/01.STR.0000209303.02474.27. 
13.  Saver, J.L., et al.; Solitaire Flow Restoration Device Versus the Merci Retriever in Patients with Acute 
Ischaemic Stroke (SWIFT): A Randomised, Parallel-Group, Non-Inferiority Trial; The Lancet; 2012; p 1241-
1249. 
14. Nogueira, R.G., Lutsep, H.L., Gupta, R., et al., Trevo versus Merci Retrievers for Thrombectomy 
Revascularization of Large Vessel Occlusions in Acute Ischaemic Stroke (TREVO 2): A Randomised Trial. 
Lancet, 2012. 280: p 1231-40. 
15.  Coutinho J, Liebeskind,D; Slater L-A, et al.; Combined Intravenous Thrombolysis and Thrombectomy 
vs Thrombectomy Alone for Acute Ischemic Stroke: A Pooled Analysis of the SWIFT and STAR Studies; 
JAMA Neurol 2017; p 268-274; DOI:10.1001/jamaneurol.2016.5374. 
 
                                                     
 

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STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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16.  Lapergue B, Blanc R, Gory B, et al.;Effect of Endovascular Contact Aspiration vs Stent Retriever on 
Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion: The ASTER 
Randomized Clinical Trial.; JAMA. 2017 Aug 1; p 443-452. DOI: 10.1001/jama.2017.9644; 
PMID:28763550 
17.  Sivan-Hoffmann R, Gory B, Rabilloud M, et al.; Patient Outcomes with Stent-Retriever Thrombectomy 
for Anterior Circulation Stroke: A Meta-Analysis and Review of the Literature; Isr Med Assoc J. 2016 Sep; 
p 561-566 
18.  Madjidvar J, Hermes J, Freitag-Wolf S, et al.; Stent-thrombus Interaction and the Influence of Aspiration 
on Mechanical Thrombectomy: Evaluation of Different Stent Retrievers in a Circulation Model; 
Neuroradiology 2015 Aug; p 791-7; DOI: 1007/s00234-015-1526-4; Epub 2015 Apr 24; PMID: 25903428. 
19. Middleton S, Levi C, Dale S, et al.; Triage, Treatment and Transfer of Patients with Stroke in Emergency 
Department Trial (the T3 Trial): A Cluster Randomised Trial Protocol; Implement Sci, 2016 Oct; p 139; 
PMID 27756434. 
20. Goyal M, Jadhav AP, Bonafe A, et al.  Analysis of workflow and time to treatment and the effects on 
outcome in endovascular treatment of acute ischemic stroke; Radiology; 2016 p. 888-897; DOI: 
10.1148/radiol.2016160204. 
21.  Grotta JC, Savitz SI, Persse D; Stroke Severity As Well As Time Should Determine Stroke Patient Triage; 
Stroke 2013 Feb; p 555-7; doi: 10.1161/STROKE AHA.112669721, Epub 2013 Jan 3; PMID: 23287779.  
22.  Audebert HJ, Saver J, Starkman S, et al.; Prehospital Stroke Care: New Prospects for Treatment and 
Clinical Research; Neurology 2013 Jul 30; p 501–508; doi:  10.1212/WNL.0b013e31829e0fdd; PMID 
PMC3776535. 
23.  Mosley I, Nicol M, Donnan G, Patrick I, Kerr F, Dewey H. The impact of ambulance practice on acute 
stroke care. Stroke. 2007; p 2765–2770. 
24. Meretoja A, Mustanoja S. Tatlisumak T, et al.; Reducing In-Hospital Delay to 20 Minutes in Stroke 
Thrombolysis; Neurology 2012 Jul; p 306-13; DOI: 10.1212/WNL.0b013e31825d6011. Epub 2012 May 23; 
PMID: 22622858. 
25. Jadhav A, Kenmuir C, Aghaebrahim A, et al.; Interfacility Transfer Directly to the Neuroangiography 
Suite in Acute Ischemic Stroke Patients Undergoing Thrombectomy; Stroke. 2017; 48:00-00. DOI: 10.1161/. 
STROKEAHA.117.016946. 
26. McTaggart RA, Yaghi S, Cutting SM, et al.; Association of a Primary Stroke Center Protocol for 
Suspected Stroke by Large-Vessel Occlusion with Efficiency of Care and Patient Outcomes; JAMA Neurol. 
2017 Jul 1; p 793-800; doi: 10.1001/jamaneurol.2017.0477; PMID: 28492918. 
27. Schlemm L, Ebinger M, Nolte C, Endres M; Impact of Prehospital Triage Scales to Detect Large Vessel 
Occlusion on Resource Utilization and Time to Treatment; Stroke 2018; 49:00-00; DOI: 
10.1161/STROKEAHA.117.019431. 
28.  Mueller-Kronast NH, et al.; Systematic Evaluation of Patients Treated With Neurothrombectomy Devices   
for Acute Ischemic Stroke: Primary Results of the STRATIS Registry; Stroke. 2017 Oct; p 2760-2768; Epub 
2017 Aug 22. 
 
 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER CORPORATION.                
 
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29.  Menon B K, et al., Analysis of Workflow and Time to Treatment on Thrombectomy Outcome in the 
Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) Randomized, 
Controlled Trial, Circulation. 2016 Jun 7;133, p 2279-86, Epub 2016 Apr 13. 
30.  Powers W J, et al., June 2015 AHA/ASA Focused Update of the 2013 Guidelines for the Early 
Management of Patients With Acute Ischemic Stroke (AIS) Regarding Endovascular Treatment, Stroke, 
October 2015, p 3020-3035. 
31. Wahlgren, N., Macho, J. Killer M., Liebeskind D., Jansen, O. Final Results from the Trevo Study 
(Thrombectomy Revascularization of large Vessel Occlusions in acute ischemic stroke). International Stroke 
Conference, 2012. 
32.  Berkhemer OA, Fransen PSS, Beumer D, et al.; A randomized trial of intraarterial treatment for acute 
ischemic stroke; N Engl J Med 2015;372:11-20; [PMID: 25517348]. 
33.  Goyal M, Menon BK, van Zwam WH, et al.; Endovascular thrombectomy after large-vessel ischaemic 
stroke: a meta-analysis of individual patient data from five randomised trials; Lancet 2016; 387:1723-31; 
[PMID: 26898852]. 
34. Nogueira R, Jadhav A, Haussen D, et al.; Thrombectomy 6 to 24 Hours after Stroke with a Mismatch 
between Deficit and Infarct (DAWN Trial); N Engl J Med 2018; 378; p 11-21; January 4, 2018  

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
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Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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18 APPENDICES 
Appendix A. 
Abbreviations  
Abbreviation/Acronym 
Full Term 
AE 
Adverse Event 
AHA 
American Heart Association 
AIS 
Acute Ischemic Stroke 
Carotid T 
Distal terminus of the carotid artery 
CATO 
Conventional Angiography Target Occlusion 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CSA 
Clinical Study Agreement 
CT 
Computed Tomography 
CTA 
Computed Tomography Angiography 
DRSAE 
Device-related SAE 
DSA 
Digital Subtraction Angiography 
ECASIII 
European Cooperative Acute Study Stroke Study III 
eCRF 
electronic Case Report Form 
eTICI 
(expanded) Thrombolysis in Cerebral Infarction 
EQ5D5L 
EuroQol Questionnaire – 5 Level 5D Version 
GCP 
Good Clinical Practices  
IA 
Intra-Arterial 
IAT 
Intra-Arterial Therapy 
ICH 
Intracranial Hemorrhage 
ID 
Identification 
IFU 
Instructions For Use 
IV 
Intravenous 
IV tPA 
Intravenous tissue Plasminogen Activator 
LAR 
Legally Authorized Representative 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER CORPORATION.                
 
 Page 36 of 41 
 
 
Abbreviation/Acronym 
Full Term 
LTKW 
Last Time Known Well 
LVO 
Large Vessel Occlusion 
MR 
Magnetic Resonance  
MRI 
Magnetic Resonance Imaging 
mRS 
Modified Rankin Scale 
PI 
Principal Investigator  
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect  
SAH 
Subarachnoid Hemorrhage 
SICH 
Symptomatic Intracranial Hemorrhage 
t-PA 
Tissue Plasminogen Activator 
UADE 
Unanticipated Adverse Device Effect 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER CORPORATION.                    
Page 37 of 41 
 
Appendix B. 
Definitions 
Access Site Complication: Complication related to the vascular access site for the index procedure including 
but not limited to bleeding, hematoma, pseudoaneurysm, tears, pain or occlusion requiring additional treatment 
such as blood transfusion or surgical repair. 
Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury or untoward clinical 
sign (including abnormal laboratory results) in subjects, users, or other persons.  NOTE - This definition does 
not imply that there is a relationship between the adverse event and the device under investigation. 
At Risk Tissue-Volume: Differentiate tissue at risk, but salvageable, from tissue that is already infarcted and 
at risk for hemorrhage with reperfusion 
Device Malfunction/Nonconformity: The failure of a device to meet its performance specifications or 
otherwise perform as intended. Performance specifications include all claims made in the labeling for the 
device. The intended performance of a device refers to the intended use for which the device is labeled or 
marketed.  
Distal Embolization (DE): Any downstream occlusion distal to the conventional angiography target occlusion 
(CATO), into the target ischemic territory, is considered DE unless complete angiogram or pre procedure non-
invasive imaging demonstrated non-patency of these distal branches. 
Early Response: A NIHSS drop of ≥10 from baseline or an excellent score of NIHSS 0 or 1 at Discharge/Day 
5-7 (whichever is earlier). 
Embolization to New Territory (ENT): Embolization into a previously uninvolved area of the brain associated 
with new ischemic changes on 24-hour postprocedural CT or MR imaging. For example, ACA embolization 
during MCA-M1 thrombectomy procedure. In ICA terminus occlusion, any MCA or ACA occlusion post 
procedure is considered distal embolization (DE) and not ENT. However, if pre procedure patency of these 
previously uninvolved territories is documented by complete angiogram or pre-intervention non-invasive 
imaging, then it would be considered ENT.  
Epidural hemorrhage: Blood between the dura mater and the arachnoid mater. 
Good Clinical Outcome: A measure of neurologic functional outcome with a score of 0–2 on the modified 
Rankin Scale (mRS), usually assessed 90 days after treatment. 
Groin Puncture: Time Skin Punctured by Needle. 
Intracranial hemorrhage: A hemorrhage, or bleeding, within the skull 
Intramural arterial dissection:  A tear or damage to the inner arterial wall that occurs during the index 
procedure.  The intramural arterial dissection may be identified angiographically as minor radiolucent area to 
luminal filling defect on imaging.   
Intraprocedure Mortality:  Death occurring during the index thrombectomy procedure 
Intra-ventricular Hemorrhage (IVH): Bleeding into the brain's ventricular system.  
In vivo (breakage) device failure:  Breakage of the Trevo device in the vasculature during the index procedure. 
Modified Rankin Scale: Scale for measuring the degree of disability or dependence in the daily activities of 
people who have suffered a stroke or other causes of neurological disability. 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
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Page 38 of 41 
 
Neurological worsening:  A 4 or more point increase in NIHSS from baseline.  Neurological worsening could 
be new or evolution/progression of the index stroke. 
NIHSS Score: 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. 
Parenchymal hemorrhage type 1 (PH-1):  A hematoma in < 30% of the infarcted area with some slight space-
occupying effect.  
Parenchymal hemorrhage type 2 (PH-2):  Dense hematoma > 30% total of the infarcted area with substantial 
space-occupying effect or any hemorrhage area outside the infarcted area. 
Pass (Start Time and Stop Time): 
Start Time is the time of the single image performed when all devices are in position for each pass. 
Stop Time is the time of the eTICI assessment completed after the pass. 
Petechial hemorrhage type I (HI-1): Small petechiae along the margins of the infarct. 
Petechial hemorrhage type II (HI-2): More confluent petechiae within the infarcted area but without space-
occupying effect 
Pre-stroke disability: Obtained at baseline, but representative of the subject’s status before the index stroke, 
assessed by mRS on medical history obtained from subject’s medical chart, or family members. 
Remote Intracerebral Hemorrhage (RIH): Any intraparenchymal hemorrhage remote from the ischemic 
field. 
Serious Adverse Device Effect (SADE):  Any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the protocol or application (including a supplementary 
plan or application), or any other unanticipated serious problem associated with a device that relates to the 
rights, safety or welfare of subjects.   
Serious Adverse Event (SAE): An adverse event in a research subject that led to a death, or led to a serious 
deterioration in the health of the subject that resulted in a life-threatening illness or injury, or resulted in a 
permanent impairment of a body structure or a body function, or required in-patient hospitalization or 
prolongation of existing hospitalization, or resulted in medical or surgical intervention to prevent permanent 
impairment to body structure or a body function. SAEs are a subset of AEs.  
• 
NOTE 1 – This definition does not imply that there is a relationship between the serious adverse 
event and the device under investigation.  
• 
NOTE 2 – Elective/planned hospitalization after the study procedure will not be regarded as an AE 
or a SAE.  However, AEs that may occur during elective hospitalization, and are unrelated to the 
elective hospitalization should be evaluated and recorded appropriately. 
 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER CORPORATION.                    
Page 39 of 41 
 
 
Stroke:  An acute neurological event with focal symptoms and signs lasting ≥ 24 hours.  Stroke can be sub-
classified as Hemorrhagic or Ischemic. 
• 
Hemorrhagic Stroke:  A symptomatic intracerebral, subarachnoid, or primary intraventricular 
hemorrhage.  To be considered a hemorrhagic stroke, the patient must experience new symptoms 
(e.g., new severe headache) that last for at least 24 hours (symptoms do not need to be associated 
with a new neurological deficit). 
• 
Ischemic Stroke:  A neurological deficit that is thought to have an ischemic cause and is detectable 
on examination at least 24 hours after onset of symptoms.       
Stroke-related Death: Death related to the index stroke; to systemic complications associated with the index 
stroke, or a new stroke. 
Subarachnoid Hemorrhage (SAH): Bleeding into the subarachnoid space - the area between the arachnoid 
membrane and the pia mater surrounding the brain.  
Subdural hemorrhage: Blood between the dura mater and the skull. 
Symptomatic ICH (SICH): The primary protocol definition is adapted from ECASS III as any apparently 
extravascular blood in the brain or within the cranium that is associated with clinical deterioration as defined 
by an increase of four points or more in the NIHSS, or that led to death and was judged to be the predominant 
cause of a neurologic deterioration.  The SITS-MOST definition of SICH is: Any PH-2 with a four point or 
more increase in NIHSS. 
Unanticipated Serious Adverse Device Effects (USADEs): Any serious adverse effect on health or safety, 
any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death 
was not previously identified in nature, severity, or degree of incidence in the application; or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. 
Vessel Perforation:  A hole or puncture (perforation) in the vessel wall that occurs unintentionally during the 
index procedure.  The perforations may be seen angiographically during the index procedure by frank or free 
extravasation of the contrast into the surrounding tissue or localized contrast extending outside the vessel lumen. 
 
 
 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER CORPORATION.                    
Page 40 of 41 
 
Appendix C. 
Expanded TICI (eTICI) Perfusion Categories 
• 
Grade 0: Equivalent to no reperfusion or 0% filling of the downstream territory. 
• 
Grade 1: Reflects thrombus reduction without any reperfusion of distal arteries. 
• 
Grade 2a: Reperfusion in less than half or 1–49% of the territory. 
• 
Grade 2b50: 50–66% reperfusion 
• 
Grade 2b67: 67-89% reperfusion 
• 
Grade 2c: 90–99% reperfusion 
• 
Grade 3: Complete or 100% reperfusion 
 
Reference 
Liebeskind DS, Bracard S, Guillemin F, et al eTICI reperfusion: defining success in endovascular stroke therapy Journal 
of NeuroInterventional Surgery Published Online First: 07 September 2018. doi: 10.1136/neurintsurg-2018-014127  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Stryker Neurovascular 
Document Title: ASSIST™ Registry Protocol 
Document Number: CDM10001414 
Rev:  AB 
STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION THAT IS THE 
PROPERTY OF STRYKER CORPORATION. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED, 
USED, OR DISCLOSED TO ANY THIRD PARTY WITHOUT THE PRIOR WRITTEN CONSENT OF STRYKER CORPORATION.                    
Page 41 of 41 
 
Appendix D. 
Informed Consent Form Template