Safety and Effectiveness of the Treatment of Wide Neck, Intracranial, Saccular Aneurysms With the Next Generation Neuroform Stent System
Phase: NA
Conditions: Intracranial Aneurysm
Sponsor: Stryker Neurovascular

 
SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
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. 
 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 1 of 74 
Sponsor: 
Stryker Neurovascular (SNV) 
47900 Bayside Parkway 
Fremont, CA 94538-6515 
Study Responsibility: 
SNV 
47900 Bayside Parkway 
Fremont, CA 94538-6515 
Office: (510) 413-2500 
Coordinating Principal 
Investigators: 
Principal Investigator 
Osama O Zaidat, MD, MS, FAAN, FAHA 
 
Co-Principal Investigator 
Brian Jankowitz, MD 
Date/Version: 
19 November, 2019 / CDM 10000880 VerAF 
Revision History 
Initial FDA Submission:  Ver03; Date: 06 Jan, 2015 
Revised FDA Submission:  Ver04; Date: 04 Feb, 2015 
Release of Alpha Version: VerAA; Date: 19 Mar, 2015 
Internal Release of Version AB: VerAB; Date: 18 Jan, 2016 (VerAB was not 
released externally to sites) 
Release of Version AC: VerAC; Date: 02 Feb, 2016 
Release of Version AD:  VerAD; Date:  24 Jun, 2016 
Release of Version AE:  VerAE; Date:  15 Aug, 2019 (VerAE was not 
released externally to sites) 
 
This protocol contains confidential information for use by the Investigators and their designated representatives 
participating in this clinical investigation. It should be held confidential and maintained in a secure location. 
Do not copy or distribute without written permission. 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 2 of 74 
Investigator’s Signature Page 
STUDY TITLE: 
Safety and Effectiveness of the Treatment of Wide Neck, Saccular 
Intracranial Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
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 
Print name: 
 
 
Date 
 
 
Co-Principal Investigator (if applicable) 
Print name: 
 
 
Date 
 
 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 3 of 74 
Table of Contents 
 
1 
Study Purpose .............................................................................................................................................. 13 
1.1 
Introduction and Background .......................................................................................................... 13 
1.2 
Rationale for Study Design and Study Population .......................................................................... 15 
1.3 
Name of Device .............................................................................................................................. 16 
1.4 
Intended Use of the Device ............................................................................................................. 17 
1.5 
Brief Description of the Device ...................................................................................................... 17 
1.6 
Study Purpose and Objectives ......................................................................................................... 17 
1.7 
Duration of the Study ...................................................................................................................... 17 
2 
Investigational Protocol .............................................................................................................................. 18 
2.1 
Study Design Overview .................................................................................................................. 18 
2.2 
Study Scope and Participating Institutions ...................................................................................... 18 
2.2.1 
Participating Institutions and Planned Number of Sites ................................................... 18 
2.2.2 
Subject Population ............................................................................................................ 19 
2.3 
Study Objectives ............................................................................................................................. 19 
2.3.1 
Primary Objectives ........................................................................................................... 19 
2.3.2 
Secondary Objectives ....................................................................................................... 19 
2.3.3 
Long-term Follow-up Objectives ...................................................................................... 20 
2.4 
Study Endpoints .............................................................................................................................. 20 
2.4.1 
Primary Endpoints ............................................................................................................ 21 
2.4.2 
Secondary Endpoints ........................................................................................................ 21 
2.5 
Study Success/Failure Criteria ........................................................................................................ 22 
2.6 
Study Population and Source of Subjects ....................................................................................... 22 
2.6.1 
Inclusion Criteria .............................................................................................................. 23 
2.6.2 
Exclusion Criteria ............................................................................................................. 24 
2.6.3 
Withdrawal and Replacement of Subjects ........................................................................ 24 
2.7 
Method of Assigning Subjects to Treatment ................................................................................... 24 
2.8 
Measures to Increase Validity and Minimize Bias .......................................................................... 25 
3 
Study Procedures ......................................................................................................................................... 25 
3.1 
Subject Screening ............................................................................................................................ 25 
3.2 
Informed Consent ............................................................................................................................ 25 
3.3 
Subject Withdrawal ......................................................................................................................... 26 
3.4 
Lost to Follow Up ........................................................................................................................... 26 
3.5 
Allocation of Subjects to Competing Studies ................................................................................. 26 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 4 of 74 
3.6 
Study Schedule of Events ............................................................................................................... 26 
3.7 
Pre-implant ...................................................................................................................................... 28 
3.7.1 
Baseline Evaluation .......................................................................................................... 28 
3.7.2 
Pre-Implant Pharmacotherapy .......................................................................................... 28 
3.8 
Implant ............................................................................................................................................ 29 
3.8.1 
Implant/Procedural Pharmacotherapy ............................................................................... 29 
3.8.2 
Implant/Procedural Steps .................................................................................................. 29 
3.8.3 
Treatment of Previously Treated Aneurysms ................................................................... 30 
3.8.4 
Implant of More than One Stent ....................................................................................... 30 
3.9 
Post-Implant .................................................................................................................................... 30 
3.9.1 
Post-Implant Pharmacotherapy ......................................................................................... 30 
3.9.2 
Post-Implant Assessments ................................................................................................ 30 
3.10 
Follow Up Visits ............................................................................................................................. 30 
3.11 
Unscheduled Visits ......................................................................................................................... 32 
4 
Statistical Methods and Considerations .................................................................................................... 32 
4.1 
Trial Success/Failure Criteria .......................................................................................................... 32 
4.2 
Sample Size Estimate and Justification ........................................................................................... 33 
4.3 
Eligibility of Subjects, Exclusions and Missing Data ..................................................................... 33 
4.4 
Analysis Populations ....................................................................................................................... 34 
4.5 
Primary Endpoints Justification ...................................................................................................... 34 
4.5.1 
Justification for Effectiveness Criteria .............................................................................. 34 
4.5.2 
Justification of Safety Criteria .......................................................................................... 40 
4.6 
Statistical Analysis .......................................................................................................................... 44 
4.6.1 
Baseline Variables ............................................................................................................ 45 
4.6.2 
Post-procedure Variables .................................................................................................. 46 
4.6.3 
Long Term Follow-up Variables ...................................................................................... 46 
4.6.4 
Pooling across Institutions ................................................................................................ 46 
4.6.5 
Additional Comparisons ................................................................................................... 47 
4.6.6 
Other Analysis Methods ................................................................................................... 47 
4.6.7 
Covariates ......................................................................................................................... 47 
4.7 
Subject Accountability .................................................................................................................... 47 
4.8 
Follow-up and Reporting ................................................................................................................ 47 
4.9 
Assessment of Attrition Bias ........................................................................................................... 47 
5 
Data Management ....................................................................................................................................... 48 
5.1 
Data Collection and Processing ...................................................................................................... 48 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 5 of 74 
6 
Adverse Events ............................................................................................................................................ 48 
6.1 
Adverse Event Definitions and Classification................................................................................. 48 
6.2 
Reporting Requirements ................................................................................................................. 50 
6.3 
Device Failures, Malfunctions, and Product Nonconformities ....................................................... 51 
6.4 
Reporting to Regulatory Authorities/IRBs / ECs /Investigators ..................................................... 51 
7 
Risk Analysis ................................................................................................................................................ 51 
7.1 
Known and Anticipated Risks ......................................................................................................... 51 
7.2 
Reported Benefits ............................................................................................................................ 52 
7.3 
Risk Minimization........................................................................................................................... 53 
7.4 
Risk Benefit Analysis...................................................................................................................... 53 
7.4.1 
Subject Population ............................................................................................................ 53 
7.4.2 
Justification for Investigation ........................................................................................... 54 
8 
Device Description ....................................................................................................................................... 54 
8.1 
Detailed Device Description ........................................................................................................... 54 
8.2 
Procedural Technique ..................................................................................................................... 56 
8.3 
Device Labeling .............................................................................................................................. 56 
9 
Monitoring Plan ........................................................................................................................................... 56 
9.1 
Monitoring Procedures .................................................................................................................... 56 
9.1.1 
Qualification and Initiation ............................................................................................... 56 
9.1.2 
Periodic Monitoring .......................................................................................................... 56 
9.1.3 
Documentation .................................................................................................................. 57 
9.2 
Name and Address of Monitor ........................................................................................................ 57 
9.3 
Auditing .......................................................................................................................................... 57 
9.4 
Device Accountability ..................................................................................................................... 58 
10 
Study Committees ....................................................................................................................................... 58 
10.1 
Steering Committee......................................................................................................................... 58 
10.2 
Clinical Events Committee/Data Safety Monitoring Board (CEC/DSMB) .................................... 58 
11 
Ethical and Regulatory Considerations ..................................................................................................... 58 
11.1 
Compliance with Good Clinical Practices (GCP) ........................................................................... 58 
11.2 
Institutional Review Board/Independent Ethics Committee ........................................................... 59 
11.3 
Written Informed Consent Form ..................................................................................................... 59 
11.4 
Amending the Protocol ................................................................................................................... 59 
11.5 
Emergency Actions ......................................................................................................................... 59 
11.6 
Protocol Adherence ......................................................................................................................... 60 
11.7 
Protocol Deviations ......................................................................................................................... 60 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 6 of 74 
12 
Study Administration .................................................................................................................................. 60 
12.1 
Pre-Study Documentation Requirements ........................................................................................ 60 
12.2 
Record Retention ............................................................................................................................ 61 
12.3 
Criteria for Terminating Study ........................................................................................................ 61 
12.4 
Criteria for Suspending/Terminating a Study Center ...................................................................... 61 
12.5 
Clinical Trial Registration ............................................................................................................... 61 
12.6 
Release of Study Results ................................................................................................................. 61 
12.7 
Medicare Beneficiaries ................................................................................................................... 62 
13 
References .................................................................................................................................................... 63 
14 
Appendices ................................................................................................................................................... 69 
List of Tables 
Table 1 – Post-Approval Study Milestones ................................................................................................................. 18 
Table 2 - Study Event Schedule through PAS Follow-up ........................................................................................... 27 
Table 3 - MAPS Cohort - Angiographic Outcomes as Assessed by an Independent Core Lab ................................... 36 
Table 4 - Summary of Effectiveness Data Derived from Literature Search ................................................................ 37 
Table 5 - MAPS Cohort - Primary Safety Outcomes .................................................................................................. 41 
Table 6 - Summary of Safety Data Derived from Literature Search ........................................................................... 42 
Table 7 – Endpoint Measure Definitions in the Post-approval Study .......................................................................... 45 
Table 8 – Adverse Event Definitions and Classifications ............................................................................................ 48 
Table 9 – Communication Requirements for Reporting Adverse Events to the Sponsor ............................................ 50 
Table 10 – Neuroform EZ Stent and Neuroform Atlas™ Stent Summary .................................................................. 55 
List of Figures 
Figure 1 - Raymond Classification of Angiographic Results ...................................................................................... 21 
Figure 2 - Schematic of Study Flow ......................................................................................................................... 23 
Figure 3 - Complete Occlusion Rates, Wide Neck Intracranial Aneurysms Only, MAPS Data from Hetts et al., 
Includes Stent Assisted Coiling Data from Hetts et al. and Chalouhi et al. ................................................................. 39 
Figure 4 - Complete Occlusion Rates, Wide Neck Intracranial Aneurysms Only, MAPS Data from MAPS Dataset, 
Includes Coiling or Balloon Assisted Coiling Data Only ............................................................................................ 40 
List of Appendices 
Appendix A:  Abbreviations………………………………………………………………………………………….69 
Appendix B:  Definitions……………………………………………………………………………………………..70 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 7 of 74 
Protocol Synopsis 
Study Title: 
SAfety and Effectiveness of the Treatment of Wide Neck, IntracraniaL, Saccular 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
Design: 
This study is designed as a prospective, multicenter, open-label, single-arm 2-cohort 
(anterior and posterior circulation) study. Eligible subjects presenting with a wide neck 
(neck ≥4mm or a dome-to-neck ratio <2), intracranial, saccular aneurysm arising from a 
parent vessel with a diameter of ≥2mm and ≤4.5 mm will receive stent-assisted coiling 
with the Neuroform Atlas™ Stent System and any approved bare metal embolic coils 
currently on the market. 
Data collected through the 12-month follow-up visit are intended to support Premarket 
Approval (PMA) application to the Food and Drug Administration (FDA). Long-term 
follow-up data collected through 3 years postoperative are intended to support post-
approval study (PAS) requirements. 
Device Name and 
Intended Use: 
For purposes of this study, “investigational device” or “test device” refers to Stryker 
Neurovascular’s Neuroform Atlas™ Stent System. 
Intended Use: 
The Neuroform Atlas™ Stent System is intended for use with bare metal embolic coils 
for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent 
vessel with a diameter  2 mm and  4.5 mm. Wide-neck aneurysms are defined as those 
having a neck  4 mm or a dome-to-neck ratio of < 2. 
Device Regulatory 
Status 
The Neuroform Atlas Stent System was FDA-approved for use in the anterior circulation 
on May 16, 2019, with the following indication: 
The Neuroform Atlas Stent System is indicated for use with neurovascular 
embolization coils in the anterior circulation of the neurovasculature for the 
endovascular treatment of patients ≥ 18 years of age with saccular wide-necked 
(neck width ≥ 4 mm or a dome-to-neck ratio of < 2) intracranial aneurysms 
arising from a parent vessel with a diameter of ≥ 2.0 mm and ≤ 4.5 mm. 
Use of the Neuroform Atlas Stent System for use in the posterior circulation is 
investigational in the United States and subject to all Investigational Device Exemption 
(IDE) regulations imposed by FDA as of the release date of the ATLAS study protocol 
Revision AF. 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 8 of 74 
Device Description: 
The Neuroform Atlas™ Stent System includes: 
• 
A self-expanding, open-cell, nitinol stent with three radiopaque marker bands on 
each end (proximal and distal) and 4 interconnects between the central stent 
segments, designed to provide support of the coil mass within an aneurysm and 
to minimize stent deflection. 
• 
A stent delivery wire.  The stent is pre-loaded on the stent delivery wire and is 
protected by an introducer sheath. 
• 
An accessory pouch containing an optional torque device.  The physician may 
attach the torque device to the proximal end of the stent delivery wire in order to 
facilitate handling and stabilization.  The stent delivery wire is not designed to 
be torqued. 
The Neuroform Atlas Stent is available in 3 diameters (3.0 mm, 4.0 mm, and 4.5 mm), 4 
lengths (15, 21, 24, and 30 mm), and 2 tip configurations (with an 8.5 mm distal tip, and 
without a distal tip). 
Primary 
Endpoints: 
The primary effectiveness endpoint of the study is: 
Complete aneurysm occlusion (100% occlusion – Raymond Class 1) of the treated target 
lesion on 12 month angiography, in the absence of retreatment, or parent artery stenosis 
(> 50%) at the target location. 
The primary safety endpoint of the study is: 
Any major ipsilateral stroke or neurological death within 12 months. 
Secondary 
Endpoints: 
The secondary safety endpoint is the percent of subjects experiencing one or more serious 
adverse events (SAEs) through 12 months post-index procedure within the following 
categories: 
• 
New or worsening major ipsilateral stroke as measured by the National Institute 
of Health Stroke Scale (NIHSS)  
• 
Device-related SAEs 
• 
Subarachnoid hemorrhage (SAH) 
• 
Aneurysm rupture 
 
The secondary effectiveness endpoints identified below will be assessed post-index 
procedure through 12 months per the schedule requirements: 
• 
Procedural technical success 
• 
Incidence of retreatment 
• 
Incidence of recanalization 
• 
Incidence of parent artery stenosis at the target aneurysm location (>50% 
stenosis) 
• 
Incidence of stent migration based on follow-up angiogram 
• 
Proportion of aneurysms with occlusion of Raymond Class 1, 2, or 3 
• 
Proportion of aneurysms with occlusion of Raymond Class 1 and 2 combined 
• 
Incidence of progressive occlusion at the target aneurysm location 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 9 of 74 
Long-term 
Follow-up 
The pre-specified safety endpoint is neurological death or major ipsilateral stroke at 12 
months as adjudicated by the Clinical Events Committee (CEC). Long-term data on this 
pre-specified safety endpoint will continue to be collected. 
For the duration of the PAS study, all new or ongoing adverse events will be collected, 
reported, reviewed, and adjudicated per the CEC charter. Long-term safety events of 
interest will be grouped into the following combined categories for FDA reporting 
purposes: 
• 
Any ischemic or hemorrhagic adverse event of any severity or duration 
(including transient ischemic attacks [TIAs], subarachnoid hemorrhage [SAH], 
and aneurysm rupture) 
• 
Device-related SAEs 
 
For imaging performed per standard of care, the long-term effectiveness outcomes 
identified below will be assessed from 12 months through 3 years  (± 6 months) post-
index procedure per the long-term follow-up schedule requirements: 
• 
Retreatment 
• 
Parent artery stenosis at the target aneurysm location (>50% stenosis) 
• 
Composite effectiveness measure (complete aneurysm occlusion [Raymond 
Class 1] without significant parent artery stenosis at the target aneurysm location 
(>50% stenosis) or retreatment) 
• 
Recanalization 
• 
Stent migration based on follow-up angiogram 
• 
Aneurysm occlusion of Raymond Class 1, 2, or 3 
• 
Aneurysm occlusion of Raymond Class 1 and 2 combined 
• 
Progressive occlusion of the target aneurysm 
Planned Number of 
Subjects: 
Up to a total of 360 subjects may be enrolled as follows:  
Anterior Circulation Cohort: 
A sample size of up to 180 subjects with intracranial aneurysms in the anterior circulation 
(excluding the petrous Internal Carotid Artery (ICA) to superior hypophyseal ICA region) 
has been selected for this study in order to provide 153 evaluable subjects at 12 months, 
with an estimated 15% attrition rate. Assuming an effectiveness primary endpoint 
response rate of 62%, the expected lower bound of the exact binomial two-sided 95% 
confidence interval around the success rate is greater than 50%. Assuming a safety 
primary endpoint rate of 8%, the expected upper bound of the exact binomial two-sided 
95% confidence interval around the success rate is less than 20%. 
A sample size of 153 evaluable subjects provides 85% power to demonstrate the 
effectiveness endpoint, and a power of approximately 99% to successfully demonstrate 
the safety endpoint given the observed rates stated above. The combined probability of 
the two endpoints is (.85) x (.99) = .842. 
Posterior Circulation Cohort: 
A sample size of up to 180 subjects with intracranial aneurysms in the posterior 
circulation (including vertebral, basilar and posterior cerebral arteries) may be enrolled in 
order to provide 153 evaluable subjects at 12 months, with an estimated 15% attrition 
rate. Assuming an effectiveness primary endpoint response rate of 62%, the expected 
lower bound of the exact binomial two-sided 95% confidence interval around the success 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 10 of 74 
rate is greater than 50%. Assuming a safety primary endpoint rate in the posterior 
circulation of 12%, the expected upper bound of the exact binomial two-sided 95% 
confidence interval around the success rate is less than 25%. 
A sample size of 153 evaluable subjects provides 85% power to demonstrate the 
effectiveness endpoint, and a power of approximately 99% to successfully demonstrate 
the safety endpoint given the observed rates stated above. The combined probability of 
the two endpoints is (.85) x (.99) = .842. 
For the posterior circulation cohort, a Bayesian adaptive study design (“Goldilocks” 
approach1) providing for interim analyses of accumulated data will be used to select the 
final sample-size. The first interim data analysis will occur once 100 posterior circulation 
subjects have been enrolled. Based on enrollment rates and the frequency of disease in the 
posterior circulation, at the time this interim analysis is performed it is estimated that 
primary endpoint data will be available for approximately 39 – 63 posterior circulation 
subjects. If, at an interim analysis, there is at least a 95% predictive probability of 
observing a true rate of complete occlusion that is higher than 50%, enrollment in the 
posterior circulation cohort will be stopped early for success. The maximum sample-size 
for the posterior circulation cohort will be no more than 180 subjects. 
Planned Number of 
Sites: 
Up to 40 sites will participate in the clinical study.  
Randomization: 
This study is a non-randomized, open label, single-arm study.  
Follow-Up 
Schedule: 
All subjects enrolled in the study will be followed clinically through hospital discharge, at 
2 months, 6 months, and 12 months post-procedure to collect primary study endpoint 
data. 
The following assessments and procedures will be performed through the 12-month 
follow-up visits: 
Discharge: 
• 
Subjects will be evaluated using neurologic rating/grading scales (mRS for 
all subjects; Hunt and Hess for subjects who previously had a ruptured 
aneurysm and evidence of subarachnoid hemorrhage). Any adverse events 
will be recorded. 
Clinical follow-up at 2 months and 6 months: 
• 
Subjects will have a neurological assessment (mRS). Antiplatelet regimen 
compliance and adverse events will be recorded. 
Clinical follow-up at 12 months: 
• 
Subjects will have a neurological examination and will be evaluated using 
neurological rating/grading scales (NIHSS, mRS; and, Hunt and Hess, as 
appropriate). Quality of Life assessment, compliance with antiplatelet 
regimen, and adverse events will be recorded. 
                                                          
1 Kristine R. Broglio, Jason T. Connor & Scott M. Berry (2014) Not Too Big, Not Too Small: A Goldilocks 
Approach To Sample Size Selection, Journal of Biopharmaceutical Statistics, 24:3, 685-705, DOI: 
10.1080/10543406.2014.888569 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 11 of 74 
Angiographic follow-up: 
• 
Digital Subtraction Angiography (DSA) will be performed at 12 months to 
determine the rate of complete aneurysm occlusion. 
For long-term follow-up, subjects will be followed  through 3 years (± 6 months) post-
procedure with neurological exams and safety assessments. If both the 2-year and the 3-
year visit windows have elapsed at the initiation of the PAS, subjects will be asked to 
return for at least 1 follow-up visit. Imaging assessment of intracranial aneurysm 
occlusion and parent artery stenosis will be performed if imaging assessments are 
conducted per institutional standard of care. 
Key Inclusion 
Criteria: 
Eligible subjects must meet ALL of the following inclusion criteria: 
• 
Subject is between 18 and 80 years of age 
• 
Documented wide neck (neck ≥ 4 mm or a dome-to-neck ratio of < 2), 
intracranial, saccular aneurysm arising from a parent vessel with a diameter of  
2mm and  4.5 mm, which will be treated with bare metal coils 
• 
Subject or legal representative is willing and able to provide informed consent 
• 
Subject is willing and able to comply with protocol follow-up requirements 
Key Exclusion 
Criteria: 
Subjects will be excluded from this study if they do not meet the specific inclusion 
criteria, or if any of the following exclusion criteria are present: 
• 
Known multiple untreated cerebral aneurysms, other than non-target blister 
aneurysm, infundibulum, or aneurysm measuring <3mm for each of three 
dimensions assessed (height, width, and depth) that will not require treatment 
during the study period 
• 
Target lesion is a blister aneurysm, infundibulum, or aneurysm measuring <3mm 
for each of three dimensions assessed (height, width, and depth) 
• 
Target aneurysm that will require an Investigator to intentionally leave a neck 
remnant in order to preserve blood flow in a bifurcation or branch 
• 
Coiling or stenting of a non-target intracranial aneurysm within 30 days prior to 
study treatment 
• 
Target aneurysm is in the anterior circulation proximal to the superior 
hypophyseal ICA 
• 
Acute target aneurysm rupture less than 14 days prior to study treatment 
• 
Hunt and Hess score ≥ 3 or a premorbid mRS score ≥4 
• 
An admission platelet count of <50,000, any known coagulopathy, or an 
International Normalized Ratio (INR)>3.0 without oral anticoagulation therapy 
• 
A known absolute contraindication to angiography 
• 
Evidence of active cancer, terminal illness or any condition which, in the 
opinion of the treating physician, would/could prevent subject from completing 
the study (e.g., a high risk of embolic stroke, atrial fibrillation, co-morbidities, 
psychiatric disorders, substance abuse, major surgery ≤ 30 days pre-procedure, 
etc.) 
• 
Known absolute contraindication to the use of required study medications or 
agents (e.g., heparin, aspirin, clopidogrel, and radiographic contrast agents, etc.) 
• 
Female subject who is pregnant or intends to become pregnant during the study 
• 
Moya-Moya disease, arteriovenous malformation(s), arteriovenous fistula(e), 
intracranial tumor(s), or intracranial hematoma(s) (unrelated to target aneurysm) 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 12 of 74 
• 
Significant atherosclerotic stenosis, significant vessel tortuosity, vasospasm 
refractory to medication, unfavorable aneurysm morphology or vessel anatomy, 
or some other condition(s) that, in the opinion of the treating physician, 
would/could prevent or interfere with access to the target aneurysm and/or 
successful deployment of the Neuroform Atlas™ Stent 
• 
Previous treatment (e.g., surgery, stenting) in the parent artery that, in the 
opinion of the treating physician, would/could prevent or interfere with 
successful use of the Neuroform Atlas™ Stent System and/or successful 
adjunctive deployment of embolic coils 
• 
Previous stent-assisted coiling of the target aneurysm 
Trial 
Success/Failure 
Criteria: 
• 
For both the anterior and posterior circulation cohorts, the lower limit of the 
95% confidence interval of the proportion of subjects who achieve the primary 
effectiveness endpoint (i.e., complete aneurysm occlusion, in the absence of 
retreatment, or > 50% parent artery stenosis at the target location, based on 
angiographic assessment at 12 months) is >50%. 
• 
For the anterior circulation cohort, the upper limit of the 95% confidence 
interval of the proportion of subjects who experience the primary safety endpoint 
(i.e., any major ipsilateral stroke or neurological death within 12 months) is 
<20%. 
• 
For the posterior circulation cohort, the upper limit of the 95% confidence 
interval of the proportion of subjects who experience the primary safety endpoint 
(i.e., any major ipsilateral stroke or neurological death within 12 months) is 
<25%. 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 13 of 74 
1 
Study Purpose 
1.1 
Introduction and Background 
An aneurysm is a balloon-like enlargement of an artery resulting from a weakening of the vessel wall. 
Aneurysms may occur in any artery in the body. Intracranial aneurysms are a significant health problem 
in the United States with an estimated 0.4% to 6% of the adult population harboring cerebral 
aneurysms.[1-3] 
Left untreated, aneurysms may continue to grow until they rupture. The annual risk of rupture of an 
intact intracranial aneurysm is estimated to be approximately 1.9%.[2] Aneurysms documented to be 
enlarging on serial neuroimaging studies have an estimated annual rupture risk of 2.4%.[4] The 
International Study of Unruptured Intracranial Aneurysms (ISUIA) evaluated the natural history of 1,937 
unruptured aneurysms in 1,449 subjects with a mean follow-up of 8.3 years.[5] The study showed that 
2.2% of these subjects had a confirmed rupture during follow-up, and 66% of these ruptures were fatal. 
If an intracranial aneurysm ruptures, blood leaks into the highly sensitive subarachnoid space around the 
brain, resulting in a subarachnoid hemorrhage (SAH). SAH causes cerebral vasospasm (constriction of 
brain arteries due to noxious blood in the subarachnoid space), which in turn causes ischemic stroke in 
up to 15-20% of subjects.[6, 7] Aneurysmal SAH is associated with a high rate of mortality, and close to 
half of these ruptures result in death within six months.[2, 5, 8] Subjects who survive an initial SAH are at 
significant risk of subsequent re-rupture. Various reports indicate that if left untreated, there is a re-
bleeding rate of more than 50% within the first six months from initial presentation of a SAH.[9, 10] 
Even if an intracranial aneurysm does not rupture, it can lead to severe complications. As the aneurysm 
grows, it can press on nerves, put pressure on brain tissue, or interfere with other arteries or veins. 
Blindness, paralysis, hydrocephalus and other morbidities can result. In addition, as thrombus forms in 
the aneurysmal sac, a piece of thrombus can break free, travel downstream, and cause a thromboembolic 
ischemic stroke. 
Current Treatment Options 
Surgical Clipping 
Prior to 1995, the traditional treatment for intracranial aneurysms was surgical clipping. In performing 
surgical clipping, the skull is surgically opened, and metal clips are applied across the aneurysm’s neck 
so as to occlude it from the parent artery and prevent a rupture. Surgical clipping is generally regarded as 
being highly effective with durable long-term results, but it is associated with higher morbidity and 
mortality rates when compared with endovascular repair of aneurysms that are amenable to either form 
of treatment. In addition, this form of treatment is more invasive, requires longer hospital convalescence, 
and is technically difficult to perform in certain parts of the brain (such as the posterior circulation).[11, 12] 
Further, wide neck aneurysms may be difficult if not impossible to treat using surgical clipping, as often 
there is no true neck present, or the neck is too wide to successfully clamp it with a surgical clip. 
Thus, this treatment modality is not a viable option for a significant number of subjects, particularly 
during the acute phase of SAH, when the presence of cerebral edema and evolving thrombus formation 
makes access to a ruptured aneurysm difficult, if not impossible. In fact, in current treatment guidelines 
for ruptured aneurysmal SAH, the American Heart Association (AHA) and the American Stroke 
Association (ASA) jointly recommend that surgical clipping should only be considered in subjects with 
large intraparenchymal hematomas and middle cerebral artery aneurysms; otherwise, endovascular 
coiling should be first considered when ruptured aneurysms are judged to be technically amenable to 
either coiling or clipping.[13] For unruptured aneurysms, surgical clipping is recommended as a treatment 
choice only in low-risk cases, such as young subjects with small, anterior circulation aneurysms.[14] 

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Embolic Coils 
In the early 1990’s, endovascular treatment of intracranial aneurysms was significantly advanced by 
Guido Guglielmi, who used electrolytically detached platinum coils to pack and embolize the aneurysm 
sac.[15] The rationale was to exclude the aneurysm from the circulation and thus reduce the risk of rupture 
and SAH. Several well-conducted, prospective, randomized, controlled trials of both ruptured and 
unruptured aneurysms demonstrated that angiographic and clinical outcomes from this treatment 
modality were equivalent to if not better than those obtained from surgical clipping.[5, 16-19] As a result, 
embolic coiling has become the standard of care worldwide for endovascular occlusion of both 
unruptured and ruptured intracranial aneurysms. 
Despite early successes, embolic coils nonetheless have their limitations because they cannot be used to 
treat all aneurysms with different morphologies. In particular, aneurysms with a wide neck are not ideal 
candidates for embolic coil treatment, and neither are large or giant aneurysms, as most large and giant 
aneurysms tend to have a wide neck.[20, 21] A wide neck can allow coils near the base of the aneurysm to 
prolapse into the parent artery, potentially causing thrombus formation in the parent artery and distal 
ischemic strokes. A wide neck thus may prevent complete packing of the aneurysm with coils, resulting 
in a relatively high rate of aneurysm recanalization, and often requiring subsequent re-treatment of the 
lesion. Guglielmi et al were the first to report achieving complete occlusion in only 15.4% of aneurysms 
with a wide neck as compared to 81.0% of those with a small neck.[22] This observation was later 
confirmed in other studies.[21, 23-25] Complete occlusion of 289 wide neck intracranial aneurysms has been 
reported at rates between 7.1% - 50.0% at mean angiographic follow-up times ranging from of 3- 30 
months.[20-22, 26-31] Achieving complete occlusion is important since intracranial aneurysm rerupture, an 
infrequent but important complication of treatment of ruptured aneurysms, has been reported to be 
strongly associated with residual filling of the treated intracranial aneurysm.[32] Similarly, complete 
occlusion following endovascular treatment of unruptured aneurysms is associated with a lower 
likelihood of aneurysm recanalization.[33] 
Adjunctive Techniques 
The often unsatisfactory results associated with embolic coiling of wide neck aneurysms has led to 
exploration of other treatment options. These treatment options include the use of coils with complex 
shapes and 3-dimensional structures to better fit the aneurysm shape, the use of ultra-soft coils to more 
densely pack the aneurysm[34], the use of liquid polymer techniques to enhance aneurysm occlusion[35], 
and the use of balloon remodeling to stabilize coil conformation within the aneurysm during coil 
embolization.[36-42] In an extensive study of these adjunctive techniques, Murayama et al reached the 
conclusion that in spite of their introduction, recanalization remained problematic (particularly in large 
and giant aneurysms), and as a result, the development of new adjunctive therapies was necessary.[24] 
Stent Assisted Coiling 
During stent assisted coiling, a stent is deployed across the neck of the aneurysm in order to provide 
protection of the parent vessel, and to stabilize the aneurysm while allowing for insertion of embolic 
coils through the stent interstices into the aneurysmal sac. The stent prevents coils from herniating into 
the parent vessel, and allows for a higher packing density of embolic coils in the aneurysmal sac, with 
the latter being associated with a reduction in aneurysm recanalization, rupture, and re-rupture rates.[26, 43] 
Technological advances in stents have allowed for the endovascular treatment of aneurysms that in the 
past would have resulted in a poor outcome, or would have not been possible due to morphological 
characteristics of the aneurysm.[26, 44, 45] In comparison to balloon-assisted coiling, stent-assisted coiling 
of wide neck aneurysms may yield lower rates of retreatment and higher rates of aneurysm obliteration 
and progression of occlusion at follow-up, with a similar morbidity rate.[38] 
Stryker Neurovascular’s Neuroform Microdelivery Stent System was initially approved for humanitarian 
use by the FDA via a Humanitarian Device Exemption (HDE) on September 11, 2002, and subsequent 
product changes (Neuroform EZ and EZ3) were approved via HDE supplements. The next-generation 
Neuroform Atlas Stent System was initially approved under an HDE supplement in November 2017, and 

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subsequently received approval via Premarket Approval (PMA) application for use with embolic coils in 
the treatment of wide-neck saccular intracranial aneurysms in the anterior circulation (P180031; May 
2019).  
Since the original approval, stent assisted coiling using the Neuroform Stent System has been the subject 
of numerous scientific articles.[26, 44, 46-58] In a meta-analysis of the published literature on the Neuroform 
Stent System, King et al[59] reported that complete occlusion rates on final follow-up averaged 61.1% 
overall in 2,111 aneurysms treated during a 10 year period (2004 to 2014). In the treatment of wide neck 
aneurysms, this represents a substantial improvement in outcomes compared to embolic coiling alone. 
Since the Neuroform Microdelivery System market introduction in the US, there have been a number of 
SAC devices approved by FDA via HDE such as the Codman Enterprise Vascular Reconstruction 
Device, MicroVention’s LVIS device, Pulsar Vascular’s PulseRider Aneurysm Neck Reconstruction 
Device, and Stryker Neurovascular’s Neuroform Atlas Stent System. In May 2018, MicroVention’s 
LVIS and LVIS Jr. coil assist stents received PMA approval (P170013). In May 2019, Stryker 
Neurovascular’s Neuroform Atlas Stent System received PMA approval for use in the anterior 
circulation. 
Flow Diverters 
Flow diverters are typically used in situations where established techniques such as coiling and stent-
assisted coiling are not viable options.[60] At present, the Pipeline Embolization Device (PED) and 
Surpass Streamline™ Flow Diverter are the only FDA-approved flow diverters available in the United 
States, and approved use of these products is limited to the treatment of wide neck aneurysms in the 
internal carotid artery (ICA) up to the terminus. A study conducted by Lanzino et al showed that flow 
diverters (specifically PED) performed better than the control group (coils).[61] 
According to Brinjikji et al[62] subjects with posterior circulation aneurysms who are treated with flow 
diverters are at higher risk of ischemic stroke, particularly perforator infarction, and subjects with larger 
aneurysms are at increased risk of ischemic stroke and SAH. These findings should be considered when 
determining the best therapeutic option for intracranial aneurysms. 
1.2 
Rationale for Study Design and Study Population 
This will be a prospective, multi-center, single arm, open label interventional study of wide neck, 
intracranial, saccular aneurysms in which subjects will undergo stent-assisted coiling using the 
Neuroform Atlas™ Stent System. Subjects invited to participate in this study will be those who have an 
aneurysm arising from a parent vessel with a diameter of 2.0 - 4.5 mm in either the distal anterior or 
posterior intracranial circulation that is accessible for endovascular treatment. 
A major shift in intracranial aneurysm treatment has occurred over the past 30 years, from exclusively 
surgical to primarily endovascular strategies, and aneurysm morphologies once considered untreatable 
endovascularly are now routinely treated with coiling with or without the adjunctive use of stents.[26] 
Particularly for wide neck saccular aneurysms, stent-assisted coiling has become a common technique 
used worldwide. However, in the United States, neurovascular stents are currently FDA-approved for this 
indication as humanitarian use devices only. This study is being conducted to gather sufficient data for a 
premarket approval application (PMA) submission to the FDA to support a safety and effectiveness 
determination and marketing approval of the Neuroform Atlas™ Stent System. 
As previously described in Section 1.1, wide neck aneurysms have been reported to have complete 
occlusion rates as low as 15.4% when treated with coils alone.[22] Due to the poor effectiveness rates 
associated with coiling alone, wide neck aneurysms are not routinely treated by this method. Surgical 
clipping of wide neck aneurysms in locations accessible for endovascular treatment occurs infrequently, 
and is no longer the treatment of choice due to the higher morbidity and mortality rates associated with 
surgery.[16] As such, there are no suitable alternative treatments that could form a reasonable concurrent 
control group. Therefore, a prospective, single arm interventional study design was selected. 

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Evaluation of effectiveness results will be undertaken by comparing 12 month complete occlusion rates 
to performance goals derived from a random effect meta-analysis of published data from subject cohorts 
with similar aneurysms who underwent coil embolization, balloon-assisted coil embolization, or stent 
assisted coiling, and had follow-up angiography. The outcome of this random effect meta-analysis was a 
weighted average rate of total occlusion of 48.8%. This outcome was found to be similar to the outcome 
of a second separate random effect meta-analysis that was performed using published data for aneurysms 
treated using coil embolization or balloon-assisted coil embolization in combination with patient-level 
data from a subset of subjects (N = 197) from the Matrix and Platinum Science (MAPS) Trial. The 
MAPS Trial was a multinational, multicenter, randomized controlled trial conducted at 43 investigational 
sites and into which 626 patients with either ruptured or unruptured intracranial aneurysms at any 
location (ranging in size from 4-20 mm) were enrolled and treated using embolic coils.[63] Key screening 
criteria, similar to the key study entry criteria developed for the ATLAS trial, were applied to identify the 
MAPS patient cohort used for this second meta-analysis. This second meta-analysis yielded a weighted 
average rate of total occlusion of 46.7%. (Note: In a previously conducted comprehensive literature 
search, Stryker Neurovascular found that there are no published data available on similar subject cohorts 
who underwent surgical clipping and had follow-up angiography results to which suitable comparisons 
could be made. As a result, surgical clipping cohorts were excluded from these two meta-analyses.) 
The success criteria for effectiveness chosen for this study [i.e., for both the anterior and posterior 
circulation cohorts, the lower limit of the 95% confidence interval of the proportion of subjects who 
achieve the primary effectiveness endpoint (i.e., complete aneurysm occlusion, in the absence of 
retreatment, or > 50% parent artery stenosis at the target location, based on angiographic assessment at 
12 months) is >50%] are based upon review and synthesis of data from these sources (see Section 4.5.1 
Justification for Effectiveness Criteria for additional details). 
Evaluation of safety results will be undertaken by comparing rates of major ipsilateral stroke and 
neurological death in the ATLAS study population to performance goals derived from 1) stroke and 
neurological death rates in the previously mentioned MAPS wide neck aneurysm patient cohort, and 2) 
literature-based rates of procedural and long-term morbidity and mortality during embolic coiling, 
balloon-assisted embolic coiling, or stent assisted coiling. 
The success criteria for safety chosen for this study (i.e., upper limit of the 95% confidence interval of 
the proportion of subjects who achieve the primary safety endpoint is <20% in the anterior circulation 
cohort and <25% in the posterior circulation cohort) are based upon review and synthesis of data from 
these sources (see Section 4.5.2 Justification for Safety Criteria for additional details). 
The anatomic criteria for the intracranial aneurysms targeted for inclusion in this study are based on the 
results of numerous studies conducted on prior generation Neuroform Stents that are FDA-approved for 
humanitarian use. The similarities and differences between the Neuroform Atlas™ Stent System and 
Neuroform Stents (Neuroform and Neuroform EZ) are summarized in Section 8. Changes in the design 
of the Neuroform Atlas™ Stent System have allowed for a stent with a thinner, lower profile and higher 
flexibility. This may provide increased navigability and improved outcomes in the treatment of more 
challenging aneurysms.  
While the Neuroform Atlas™ Stent is the next generation Neuroform Stent and may have advantages 
over Neuroform and Neuroform EZ, all three stents were designed for the same clinical application; for 
use with embolic coils for the treatment of wide neck intracranial aneurysms. Additionally, the 
Neuroform Atlas™ Stent System is intended for use in target intracranial aneurysms that could also be 
considered for surgical clipping based on anatomic location, and this is consistent with current clinical 
practice worldwide wherein this subpopulation is routinely treated with stent-assisted coiling as the 
preferred treatment of choice.  
1.3 
Name of Device 
For purposes of this study, “investigational device” or “test device” refers to Stryker Neurovascular’s 
(SNV) Neuroform Atlas™ Stent System. 

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1.4 
Intended Use of the Device 
The Neuroform Atlas™ Stent System is intended for use with bare metal embolic coils for the treatment 
of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of  2 mm 
and  4.5 mm. Wide neck aneurysms are defined as having a neck  4 mm or a dome-to-neck ratio of < 
2. 
1.5 
Brief Description of the Device 
The Neuroform Atlas™ Stent System is comprised of a stent and delivery system and is designed for use 
as an adjunct to embolic coils in the treatment of wide neck, intracranial, saccular aneurysms. The 
Neuroform Atlas™ Stent System is comprised of three components: an implant, an introducer sheath, 
and a delivery wire assembly. The implant component is made of biocompatible nitinol tubular material. 
Three radiopaque markers are attached to the distal and proximal ends of the implant. The introducer 
sheath component has a clear thin-walled polymer shaft with a distal tapered tip designed to fit inside the 
hub of the delivery catheter. The implant is pre-loaded on the stent delivery wire and protected by a 
transfer sheath. (A detailed description of the device is provided in Section 8.1.) 
1.6 
Study Purpose and Objectives 
The purpose of this investigational study is to evaluate safety and effectiveness of the Neuroform Atlas™ 
Stent System for use with bare metal embolic coils for the treatment of wide neck, intracranial, saccular 
aneurysms arising from a parent vessel with a diameter of  2 mm and  4.5 mm. 
The primary study objectives are as follows: 
o 
To evaluate effectiveness of the Neuroform Atlas™ Stent System as an adjunct to embolic 
coiling for the endovascular treatment of wide neck, intracranial saccular aneurysms by 
comparing complete aneurysmal occlusion rates achieved with stent-assisted coiling to 
performance goals established based on historical control data for occlusion rates achieved with 
coiling, balloon-assisted coiling, or stent assisted coiling. In the study population, complete 
aneurysm occlusion will be defined as 100% occlusion (Raymond Class 1) of the target 
aneurysm, in the absence of retreatment, or parent artery stenosis (>50%) at the target location, 
as measured with 12 month angiography evaluated by an independent Imaging Core Laboratory 
(Core Lab). Results from a meta-analysis of data from the published literature will serve as a 
basis for the established effectiveness performance goals.  
o 
To evaluate safety of the Neuroform Atlas™ Stent System as measured by the rate of major 
ipsilateral stroke or neurological death within 12 months. Safety data from a MAPS wide-neck 
aneurysm patient cohort and published rates of procedural and long-term morbidity and 
mortality for embolic coiling, balloon assisted embolic coiling, or stent assisted coiling will 
serve as a basis for the established safety performance goals.  
1.7 
Duration of the Study 
It is anticipated that the enrollment of a maximum of 360 subjects in this pivotal trial will take 
approximately 40 months at up to 40 centers. Evaluation of the primary safety and effectiveness 
endpoints will be completed on all subjects at 12 months. The time required to complete enrollment of up 
to 360 subjects and 12 month follow up for all study subjects is anticipated to take approximately 52 
months. 
Evaluation of long-term safety will continue through 3-year (± 6 months) follow-up. Inclusive of long-
term follow-up it is anticipated the entire duration of the study, from the date the first subject enrolled 
into the IDE study through the date the last subject completed a 3-year PAS follow-up visit, will be 
approximately 6 years (the PAS phase of the study is anticipated to last 24 months). To allow adequate 
monitoring of PAS progress, PAS study milestones are summarized in Table 1. 

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Table 1 – Post-Approval Study Milestones 
Study Milestone 
Timeframe 
Due Date 
FDA Protocol Approval 
60 calendar days after revised PAS protocol 
submission to FDA 
January 31, 2020 
IRB Enrollment Initiation 
First IRB approval for PAS protocol 
February 29, 2020 
Patient Enrollment Initiation 
First subject long-term follow-up after IRB 
approval of PAS protocol at first site 
March 31, 2020 
IRB Enrollment Completion 
Last IRB approval of the PAS protocol 
September 30, 2020 
Patient Enrollment Completion 
Last subject 3-year long-term follow-up in-
person visit 
June 30, 2021 
Complete Follow-up of All 
Study Participants 
Subjects complete 3-year assessment 
August 31, 2021 
Final Report 
Within 3 months after study completion 
October 31, 2021 
 
2 
Investigational Protocol 
2.1 
Study Design Overview 
The purpose of this study is to evaluate safety and effectiveness of the Neuroform Atlas™ Stent System 
in the endovascular treatment of wide neck, intracranial, saccular aneurysms. 
This is a prospective, multicenter, single arm, open-label interventional study. Subjects presenting with 
wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of 2.0 - 4.5 mm 
in either the distal anterior or posterior circulation will undergo stent assisted coiling using the 
Neuroform Atlas™ Stent System in conjunction with any approved bare metal embolic coils currently on 
the market. Wide neck aneurysms are defined by a neck ≥4mm or a dome-to-neck ratio of<2. Each 
subject will be followed and assessed for the primary study endpoints at 2, 6, and 12 months after 
treatment.  
Long-term follow-up will continue through 3 years (± 6 months) post-procedure. Sites will schedule at 
least one long-term follow-up visit for each subject, including those who are beyond the 3-year visit 
window. 
2.2 
Study Scope and Participating Institutions 
2.2.1 
Participating Institutions and Planned Number of Sites 
This pivotal trial will include a maximum of 40 clinical sites. A list of participating institutions will be 
updated every 6 months and provided to regulatory authorities as required. 

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2.2.2 
Subject Population 
Detailed subject enrollment criteria are provided in Section 2.6, Study Population and Source of 
Subjects. Up to a total of 360 subjects with wide neck, intracranial, saccular aneurysms will be enrolled 
as follows: 
• 
Anterior Circulation (AC) Cohort: 
Up to 180 subjects with intracranial aneurysms in the anterior circulation (excluding the petrous 
ICA to superior hypophyseal ICA region) may be enrolled in order to provide 153 evaluable 
subjects at 12 months, with an estimated 15% attrition rate. These data will be used to support a 
safety and effectiveness analysis for an indication for use of the Neuroform Atlas™ Stent System 
in the anterior circulation. 
• 
Posterior Circulation (PC) Cohort: 
Up to 180 subjects with intracranial aneurysms in the posterior circulation (including vertebral, 
basilar and posterior cerebral arteries) may be enrolled in order to provide 153 evaluable subjects 
at 12 months, with an estimated 15% attrition rate. These data will be analyzed separately from the 
AC Cohort data, and will be used to support an indication for use of the Neuroform Atlas™ Stent 
System in the posterior circulation. 
For the posterior circulation cohort, a Bayesian adaptive study design (“Goldilocks” approach) 
providing for interim analyses of accumulated data will be used to select the final sample-size. The 
first interim data analysis will occur once 100 posterior circulation subjects have been enrolled. 
Based on enrollment rates and the frequency of disease in the posterior circulation, at the time this 
interim analysis is performed it is estimated that primary endpoint data will be available for 
approximately 39 – 63 posterior circulation subjects. If, at an interim analysis, there is at least a 
95% predictive probability of observing a true rate of complete occlusion that is higher than 50%, 
enrollment in the posterior circulation cohort will be stopped early for success. The maximum 
sample-size for the posterior circulation cohort will be no more than 180 subjects. 
2.3 
Study Objectives 
2.3.1 
Primary Objectives 
The primary objectives of this study are to: 
• 
To evaluate effectiveness of the Neuroform Atlas™ Stent System as an adjunct to embolic coiling 
for the endovascular treatment of wide neck, intracranial, saccular aneurysms by comparing 
complete aneurysm occlusion rates achieved with stent-assisted coiling to performance goals 
established based on historical control data for occlusion rates achieved with coiling, balloon-
assisted coiling, or stent assisted coiling. In the study population, complete aneurysm occlusion will 
be defined as 100% occlusion (Raymond Class 1) of the target aneurysm, in the absence of 
retreatment, or parent artery stenosis (>50%) at the target location, as measured with 12-month 
angiography evaluated by an independent Core Lab. A meta-analysis of data from the published 
literature will serve as a basis for the established effectiveness performance goals. 
• 
To evaluate safety of the Neuroform Atlas™ Stent as measured by the rate of any major ipsilateral 
stroke or neurological death within 12 months. Safety data from a MAPS wide-neck aneurysm 
patient cohort and published rates of procedural and long-term morbidity and mortality for embolic 
coiling, balloon-assisted embolic coiling, or stent assisted coiling will serve as a basis for the 
established safety performance goals. 
2.3.2 
Secondary Objectives 
The secondary objectives of this study are: 

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o 
To evaluate procedural technical success (defined as the proportion of subjects in whom the stent 
was successfully delivered to, and deployed at, the target location) using the Neuroform Atlas™ 
Stent System. 
o 
To evaluate the incidence of ipsilateral ischemic stroke post treatment. 
o 
To evaluate safety of the device as measured by the incidence of device related serious adverse 
events. 
o 
To evaluate functional outcome as defined by the modified Rankin Scale (mRS). 
o 
To evaluate all-cause mortality. 
o 
To evaluate the rate of target aneurysm occlusion and recanalization. 
o 
To evaluate the rate of target aneurysm retreatment. 
o 
To evaluate stent migration at the 12 month angiogram.  
o 
To evaluate parent artery patency at 12 months post procedure. 
2.3.3 
Long-term Follow-up Objectives 
The objective of long-term follow-up is to gather safety and effectiveness information on the durability 
and safety of treatment using the Neuroform Atlas™ Stent System up to 3 years (± 6 months) 
postoperative. The specific long-term objectives are: 
o 
To evaluate safety of the device as measured by the occurrence of 1 or more SAEs from 12 months 
through 3 years post-index procedure within the following categories: 
▪ 
Neurological death or major ipsilateral stroke 
▪ 
Any ischemic or hemorrhagic adverse event of any severity or duration (including 
transient ischemic attacks [TIAs], subarachnoid hemorrhage [SAH] and aneurysm 
rupture) 
▪ 
Device-related SAEs 
All new and ongoing adverse events will be recorded and adjudicated as specified by the CEC 
charter. 
o 
To evaluate the long-term effectiveness and durability of treatment from 12 months through 3 years 
post-index procedure, based on 2- and 3-year  (± 6 months) clinical follow-up and imaging 
performed per standard of care, for the following endpoints: 
▪ 
Retreatment 
▪ 
Parent artery stenosis at the target aneurysm location (>50% stenosis) 
▪ 
Composite effectiveness measure (complete aneurysm occlusion [Raymond Class 1] 
without significant parent artery stenosis at the target aneurysm location (>50% stenosis) 
or retreatment) 
▪ 
Recanalization 
▪ 
Stent migration based on follow-up angiogram 
▪ 
Aneurysm occlusion of Raymond Class 1, 2, or 3 
▪ 
Aneurysm occlusion of Raymond Class 1 and 2 combined 
▪ 
Progressive occlusion of the target aneurysm 
 
2.4 
Study Endpoints 
The study contains a single treatment arm with subjects receiving the Neuroform Atlas™ Stent. The 
primary endpoints will be evaluated for all subjects treated with this investigational device. 

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2.4.1 
Primary Endpoints 
2.4.1.1 Primary Effectiveness Endpoint 
The primary effectiveness endpoint of the study is: 
Complete aneurysm occlusion (100% occlusion – Raymond Class 1) of the treated target lesion on 12 
month angiography, in the absence of retreatment, or parent artery stenosis (>50%) at the target location. 
The Raymond Class 1[64] designation of complete occlusion (Figure 1) will be used to define occlusion 
success.  
 
 
Class 1 
Class 2 
Class 3 
Complete Obliteration 
Residual Neck 
Residual Aneurysm 
Figure 1 - Raymond Classification of Angiographic Results 
When assessing effectiveness, all images will be reviewed by an independent Core Lab per a Core Lab 
Radiographic Imaging Protocol. The Core Lab will be selected and qualified by the Sponsor prior to 
enrollment of the first study subject, and will develop the Core Lab Radiographic Imaging Protocol 
prospectively. To avoid interobserver variability, the Sponsor will use a Core Lab where all Core Lab 
readings will be performed by a single reviewer who will be blinded to assessments made by the clinical 
sites. In order to ensure reliable collection of images suitable for analysis, the Core Lab that is selected 
will develop guidelines for image acquisition, and will share these guidelines with clinical sites 
participating in the study. 
2.4.1.2 Primary Safety Endpoint 
The primary safety endpoint is: 
Any major ipsilateral stroke or neurological death within 12 months. 
An ipsilateral stroke will be defined as an acute episode of focal or global neurological dysfunction due 
to brain or retinal infarction, or due to an intracranial hemorrhage inclusive of subarachnoid, 
intraventricular or intraparenchymal hemorrhage, occurring in the same hemisphere as the target 
aneurysm. 
A major ipsilateral stroke will be defined as an ipsilateral stroke that is associated with an increase of 4 
or more points on the NIHSS at 24 hours after symptoms onset. 
Note: For the purpose of consistency with the primary endpoint definition, strokes in the posterior 
circulation adjudicated as being strokes “within the treated vascular territory” will be called “ipsilateral” 
strokes. 
2.4.2 
Secondary Endpoints 
2.4.2.1 Effectiveness 
The secondary effectiveness endpoints identified below will be assessed post-index procedure through 12 
months per the schedule requirements. 

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o 
Procedural technical success (defined as the proportion of subjects in whom the stent was 
successfully delivered to, and deployed at, the target location) 
o 
Incidence of retreatment 
o 
Incidence of recanalization (defined as a categorical increase in aneurysm filling over time after 
some degree of occlusion has been achieved initially) 
o 
Incidence of parent artery stenosis at the target aneurysm location (>50% stenosis) 
o 
Incidence of stent migration based on follow up angiogram 
o 
Proportion of aneurysms with occlusion of Raymond Class 1, 2 or 3 
o 
Proportion of aneurysms with occlusion of Raymond Class 1 and 2 combined 
o 
Incidence of progressive occlusion at the target aneurysm location 
2.4.2.2 Safety 
The secondary safety endpoint is the percent of subjects experiencing one or more serious adverse events 
(SAE) through 12 months post-index procedure within the following categories (definitions are provided 
in the Appendices). 
o 
New or worsening major ipsilateral stroke as measured by NIHSS  
o 
Device related serious adverse events 
o 
Subarachnoid hemorrhage (SAH) 
o 
Aneurysm rupture 
2.5 
Study Success/Failure Criteria 
o 
For both the anterior and posterior circulation cohorts, the lower limit of the 95% confidence 
interval of the proportion of subjects who achieve the primary effectiveness endpoint (i.e., 
complete aneurysm occlusion, in the absence of retreatment and > 50% parent artery stenosis at 
the target location, based on angiographic assessment at 12 months) is >50%. 
o 
For the anterior circulation cohort, the upper limit of the 95% confidence interval of the proportion 
of subjects who experience the primary safety endpoint (i.e., any major ipsilateral stroke or 
neurological death within 12 months) is <20%. 
o 
For the posterior circulation cohort, the upper limit of the 95% confidence interval of the 
proportion of subjects who experience the primary safety endpoint (i.e., any major ipsilateral 
stroke or neurological death within 12 months) is <25%. 
2.6 
Study Population and Source of Subjects 
Subjects over 18 years of age presenting with wide neck, intracranial, saccular aneurysms requiring 
treatment with stent-assisted coiling may be eligible for study participation. Potential study candidates or 
their legal representatives will provide informed consent prior to any data collection. A screening and 
enrollment log will be provided to study sites to maintain a record of all screened subjects. 
Subjects will be identified and recruited by Clinical Investigators and/or their designated research staff at 
a maximum of up to 40 investigative sites. Clinical investigators selected to participate in the study may 
enroll and treat a maximum of 20% of subjects enrolled in either cohort.  
Subjects who sign an IRB or EC approved consent form will be considered enrolled in the study. Any 
subject consented, whether treated or not, will be assigned a screening number. Subjects who consent to 
participate but withdraw or are found to be ineligible prior to initiation of the procedure will be 
considered a screening failure, and the reasons for the screening failure will be documented on the site 

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Aneurysms with the Neuroform Atlas™ Stent System 
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screening log. In all cases where subjects are consented but not treated using a Neuroform Atlas™ Stent, 
replacement subjects will be enrolled. Subjects in whom an investigational procedure is attempted but 
stent delivery is unsuccessful will be followed through the two month follow-up visit; these subjects will 
be considered treatment failures but will not be evaluated for the primary endpoints at 12 months. All 
treated subjects with successful stent delivery and deployment will be evaluated for the primary 
endpoints at 12 months post-procedure.  
For long-term follow-up, subjects will be asked to return for clinical follow-up visits at 2 years and 3 
years (± 6 months) post-index procedure. 
The study flow is depicted in Figure 2. 
 
 
Figure 2 - Schematic of Study Flow 
2.6.1 
Inclusion Criteria 
Candidates must meet ALL of the following inclusion criteria: 
1. Subject is between 18 and 80 years of age 
2. Subject has a documented, wide neck (neck ≥4mm or a dome-to-neck ratio <2), intracranial, 
saccular aneurysm arising from a parent vessel with a diameter of  2mm and  4.5 mm, which 
will be treated with bare metal coils 
3. Subject or legal representative is willing and able to provide informed consent 

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4. Subject is willing and able to comply with protocol follow up requirements 
2.6.2 
Exclusion Criteria 
Candidates will be excluded from this study if they do not meet the specific inclusion criteria, or if ANY 
of the following exclusion criteria are present: 
1. Subject has known multiple untreated cerebral aneurysms, other than non-target blister aneurysm, 
infundibulum, or aneurysm measuring <3mm for each of three dimensions assessed (height, width, 
and depth) that will not require treatment during the study period 
2. Subject has a target lesion that is a blister aneurysm, infundibulum, or aneurysm measuring <3mm 
for each of three dimensions assessed (height, width, and depth) 
3. Subject has a target aneurysm that will require an Investigator to intentionally leave a neck 
remnant in order to preserve blood flow in a bifurcation or branch 
4. Subject has undergone coiling or stenting of a non-target intracranial aneurysm within 30 days 
prior to study treatment 
5. Subject has a target aneurysm in the anterior circulation proximal to the superior hypophyseal ICA 
6. Subject has acute target aneurysm rupture less than 14 days prior to study treatment 
7. Subject has a Hunt and Hess score ≥ 3 or a premorbid mRS score ≥4 
8. Subject has an admission platelet count of<50,000, any known coagulopathy, or an International 
Normalized Ratio (INR)>3.0 without oral anticoagulation therapy 
9. Subject has a known absolute contraindication to angiography 
10. Subject has evidence of active cancer, terminal illness, or any condition which, in the opinion of 
the treating physician, would/could prevent the subject from completing the study (e.g., a high risk 
of embolic stroke, atrial fibrillation, co-morbidities, psychiatric disorders, substance abuse, major 
surgery ≤ 30 days pre-procedure, etc.) 
11. Subject has a known absolute contraindication to the use of required study medications or agents 
(e.g., heparin, aspirin, clopidogrel, and radiographic contrast agents etc.) 
12. Subject is female and is pregnant or intends to become pregnant during the study 
13. Subject has Moya-Moya disease, arteriovenous malformation(s), arteriovenous fistula(e), 
intracranial tumor(s), or intracranial hematoma(s) (unrelated to target aneurysm) 
14. Subject has significant atherosclerotic stenosis, significant vessel tortuosity, vasospasm refractory 
to medication, unfavorable aneurysm morphology or vessel anatomy, or some other condition(s) 
that, in the opinion of the treating physician, would/could prevent or interfere with access to the 
target aneurysm and/or successful deployment of the Neuroform Atlas™ Stent 
15. Subject has had previous treatment (e.g., surgery, stenting) in the parent artery that, in the opinion 
of the treating physician, would/could prevent or interfere with successful use of the Neuroform 
Atlas™ Stent System and/or successful deployment of embolic coils 
16. Subject has undergone previous stent-assisted coiling of the target aneurysm 
2.6.3 
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 who received treatment 
will not undergo any additional follow-up, nor will they be replaced (the justified sample size considers 
an estimated allowance for attrition). If a subject is consented and not treated, a replacement subject will 
be enrolled.  
2.7 
Method of Assigning Subjects to Treatment 
This is a prospective single arm study in which all subjects who present for stent-assisted coiling, provide 
informed consent, and meet inclusion/exclusion criteria may receive treatment (Neuroform Atlas™ Stent 
System). Eligible subjects will be consecutively enrolled at each site. Reason for screen failures will be 
documented. 

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2.8 
Measures to Increase Validity and Minimize Bias 
The following measures will be in place to increase validity and minimize bias.  
1. Multiple clinical trial sites will be utilized to ensure generalizability of results and minimize 
site/operator effect. 
2. The primary study effectiveness endpoint will be based on angiographic readings from an 
independent Core Lab blinded to operator assessment of outcomes and clinical data. Pre-
determined evaluation criteria will be applied to review and analysis of the data. 
3. The primary safety endpoint will be based on the incidence of established safety parameters as 
adjudicated by an independent CEC. 
4. Study monitors will review and verify data collection forms against source documentation to 
ensure that there are no missing, illegible or incorrect data. Missing, illegible or incorrect data will 
be corrected following ICH/GCP guidelines. 
5. Investigative site personnel will contact subjects prior to their scheduled study visits to increase 
compliance with the subject follow up protocol.  
3 
Study Procedures 
3.1 
Subject Screening 
Subjects will not be recruited until the Food and Drug Administration (FDA), local regulatory authorities 
(as applicable), and the local Institutional Review Board (IRB) or Independent Ethics Committee (IEC) 
have approved the study. Site Investigators will assess potential subjects with wide neck intracranial 
aneurysms for enrollment in the study. The subject’s suitability for treatment with the Neuroform 
Atlas™ Stent System will be evaluated based on medical and anatomical criteria as outlined in the 
inclusion/exclusion criteria. Angiograms (CTA, DSA or MRA) to determine suitable subjects may be 
generated up to 6 months prior to the treatment date. 
NOTE:  Data obtained prior to consenting as standard of care can be used for screening and completion 
of study CRFs. 
If a subject meets the eligibility criteria for the study, this will be documented in the site’s study 
screening log. If a subject fails to meet the eligibility criteria, the reason(s) for this will likewise be 
documented in the screening log. The screening log serves as a method for the Sponsor to ensure that 
there is no selection bias in the trial. 
3.2 
Informed Consent 
Subjects will be informed by the Investigator or the Investigator’s designee that they are free to refuse 
participation in this research study. If they elect to participate, it will be made clear that they may 
withdraw from the study at any time without prejudicing further care. 
The Investigator or the Investigator’s designee will inform subjects that their medical records will be 
subject to review by the Sponsor or appropriate regulatory bodies. This information will be used during 
the analysis of the results of the clinical study, but the subjects’ identities will be treated as confidential. 
Subjects will be assigned a unique identification code. This code will be used on all data and data 
collection forms during the study period. It will not reveal the subject’s identity. 
The Investigator will explain the conditions of the study, giving the subject sufficient time to ask 
questions and to consider whether or not they want to participate. Subjects will be informed that active 
study participation is expected through their 12-month follow-up visit, but the informed consent form 
will allow for continued follow-up through 60 months post-treatment should longer term follow-up 

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become necessary. Eligible subjects who agree to participate will be asked to sign and date an IRB 
approved informed consent form. One copy of the signed and dated informed consent form shall be 
returned to the Investigator and filed in the subject’s case history, and one copy shall be provided to the 
subject for his/her personal records. 
3.3 
Subject Withdrawal 
A subject has the right to voluntarily withdraw from the study at any time and for any reason without 
prejudice to his or her future medical care by the Investigator(s) or the Institution. The Investigator(s) 
may elect at any time to withdraw a subject from the study for any reason unrelated to the study 
treatment if such a decision is in the subject’s best medical interest. If a subject discontinues the study 
after undergoing the investigational procedure, or is withdrawn by the Investigator(s), as much follow-up 
data as possible will be obtained. Attempts will be made to retrieve follow-up data, prior to the time 
point at which voluntary consent was withdrawn, in particular regarding possible AEs at the time of 
study discontinuation.  
An enrolled subject who is found to be ineligible to participate in the study after signing the consent form 
will be exited from the study at determination of ineligibility. If a subject is consented and not treated, a 
replacement subject will be enrolled. If a subject is withdrawn from the study after treatment for any 
reason, he or she will not be replaced. 
All enrolled subjects are expected to continue to participate in the study through the final follow up 
assessment as outlined in this protocol, or until such time as the Sponsor or the Sponsor’s authorized 
designee notifies the Investigator in writing that further follow up is no longer required, except in the 
event of death, or upon the subject’s written request for early withdrawal from the clinical study. If a 
request for early withdrawal is received, a copy of the request should be forwarded directly to the 
Sponsor or the Sponsor’s authorized designee for documentation purposes. 
3.4 
Lost to Follow Up 
A subject will be considered “lost to follow up” and will be terminated from the study when he or she 
can no longer be reached by study staff and have missed study visits. The site must notify the Sponsor of 
subject status, and must consult with the Sponsor regarding discontinuation of any study subject prior to 
ceasing all attempts to contact such subjects. A subject may only be categorized as lost to follow up if the 
following criteria are met: 
o 
Failure to complete 12-month or two consecutive follow up visits, and 
o 
Documentation of three unsuccessful attempts by the Investigator or his/her designee to contact 
the subject and/or next of kin 
For long-term follow-up, subjects will be considered lost-to-follow-up if the documentation criterion is 
met. 
3.5 
Allocation of Subjects to Competing Studies 
In the event that a study center is participating in similar and competing research studies with the same or 
similar subject populations, the Investigator must provide documentation to the Sponsor or the Sponsor’s 
authorized designee outlining the methods that the center is using for appropriate subject allocation in 
order to minimize selection bias. 
3.6 
Study Schedule of Events 
Table 2 - Study Event Schedule through PAS Follow-up presents a schedule of the observations and 
assessments that have taken or will take place from subject enrollment into the IDE study through the 
duration of the PAS phase of the study.

 
SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL Aneurysms with the Neuroform Atlas™ Stent 
System 
Short Study Name: ATLAS 
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. 
 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 27 of 74 
Table 2 - Study Event Schedule through PAS Follow-up 
 
ATLAS IDE Event Schedule 
ATLAS PAS Event Schedule£ 
 
Pre-Implant 
Implant / 
Procedural 
Post-
Implant† 
2 Months 
(60d) 
± 1 month 
6 Months 
(180d) 
± 1 month 
12 Months 
(365d) 
± 2 months 
2 Years 
(730d) 
± 6 months 
3 Years 
(1095d) 
± 6 months 
Post 3-Years 
(43 – 60 
months) †† 
Medical History 
X 
 
 
 
 
 
 
 
 
Neurological Exam* 
X 
 
 
 
 
X 
X∞ 
X∞ 
X∞ 
mRS* 
X 
 
X 
X 
X 
X 
X∞ 
X∞ 
X∞ 
NIHSS*/** 
X 
 
 
+/-** 
+/-** 
X 
X∞ 
X∞ 
X∞ 
Hunt and Hess*/*** 
X 
 
X 
 
 
X 
X∞ 
X∞ 
X∞ 
Angiography**** 
X**** 
(MRA, CTA 
or DSA) 
X 
(DSA) 
 
+/-**** 
(MRA or DSA, 
per institution 
standards) 
+/-**** 
(MRA or 
DSA, per 
institution 
standards) 
X 
(DSA) 
+/-**** 
(MRA, CTA, 
or DSA, per 
institution 
standards) 
+/-**** 
(MRA, CTA, 
or DSA, per 
institution 
standards) 
+/-**** 
(MRA, CTA, 
or DSA, per 
institution 
standards) 
Adverse Event 
X 
X 
X 
X 
X 
X 
X∞ 
X∞ 
X∞ 
Antiplatelet 
X 
 
X 
X 
X 
X 
X 
X 
X 
Quality of Life 
X 
 
 
 
 
X 
 
 
 
† 
Assessments must be performed within 72 hours after implant procedures, and prior to hospital discharge. 
††  
Post 3-year visits are required only for those subjects whose index procedure took place ≥ 43 months and ≤60 months prior to their enrollment into the PAS phase of the study. 
* 
At each Clinical Trial Site, a non-treating physician (or an appropriately trained/qualified designee) will be responsible for performing neurological examinations and/or performing assessments 
using neurologic rating/grading scales (mRS, NIHSS, Hunt and Hess). In addition, a neurological examination and/or an assessment using a neurologic rating/grading scale may be performed at any 
point in time if it is appropriate to do so, or in the case of a new neurological event. 
** 
The NIHSS is required at baseline and at 12 months of follow-up. In addition, the NIHSS is required at the 2- and 6-month follow-up visit and at any unscheduled visit if the subject’s mRS score is 
> 0 in association with an adverse neurological event. 
*** 
Hunt and Hess scoring will be performed only when evaluating subjects who have evidence of subarachnoid hemorrhage. 
**** 
Pre-implant angiography (MRA, CTA, or DSA) may be performed up to 6 months prior to treatment. In addition to the post-implant and 12 month angiographic studies, it is recommended that an 
imaging study be performed within 24 hours of the onset of symptoms in any treated subject suspected of having a stroke. Although not required, if it is standard of care to do so at a given Clinical 
Trial Site, imaging (MRA or DSA) may be performed at the 2- or 6-month follow-up visit or per standard of care at each institution for the 2  and 3 years long term follow up visit. 
∞ 
At 2-year, 3-year, and post 3-year follow-up, NIHSS, mRS and neurological exams will be collected if performed. For any suspected stroke events that occur in the PAS, NIHSS will be collected at 
the time of event and at 24 hours post event; mRS will be collected at discharge from event and at a minimum of 90 days post event. For any aneurysm rupture case, Hunt and Hess grade will be 
performed or collected if available. Any imaging performed due to suspected stroke event will be submitted to the sponsor. AEs can be collected via retrospective chart review, phone calls or in-
person visits and will include all the new and ongoing adverse events. 
£ 
At least one (1) ATLAS PAS visit will be conducted in-person.  

 
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CDM10000880, VerAF 
Page 28 of 74 
 
3.7 
Pre-implant 
3.7.1 
Baseline Evaluation 
Once the Site Investigator has verified that the subject meets all of the study eligibility criteria, and once 
the subject has signed the informed consent, the subject will undergo a baseline evaluation. This will 
consist of the following assessments and/or procedures as performed on all subjects prior to implant: 
o 
Medical history 
o 
Neurological examination (including global neurological assessments and evaluation for cranial 
nerve deficits) 
NOTE:  If visual field abnormalities are evident upon examination, a formal ophthalmology 
consult with visual field analysis should be obtained. 
o 
Neurologic rating/grading scales including the following: 
▪ 
mRS (all subjects) 
▪ 
NIHSS (all subjects) 
▪ 
Hunt and Hess (for subjects with a ruptured aneurysm and evidence of subarachnoid 
hemorrhage) 
o 
Angiography (DSA, CTA, or MRA; may be performed up to 6 months prior to treatment) 
o 
Quality of Life (QoL) assessment 
QoL data will be collected using the EQ-5D-3L™ system, a generic, standardized, validated [65] 
measure of health status consisting of two parts:  
Descriptive System 
▪ 
Consists of 5 dimensions (5D) including mobility, self-care, usual activities, 
pain/discomfort, and anxiety/depression 
▪ 
Subjects rate each dimension using 3 levels (3L) including no problems, some problems, 
and extreme problems 
Visual Analogue System (VAS) 
▪ 
Presented in a thermometer-like fashion 
▪ 
Records the self-rated health of a subject on a scale of 0-100 (worst to best imaginable 
health state) 
3.7.2 
Pre-Implant Pharmacotherapy 
The following standard antiplatelet regimen is recommended for pre-implant use in enrolled subjects 
with unruptured aneurysms in accordance with routine clinical practice. Substitutions for these 
medications are allowed at the discretion of the Investigator as long as the antiplatelet efficacies are 
equivalent. Do not use the Neuroform Atlas™ Stent System or embolic coils in subjects in whom 
antiplatelet therapy is contraindicated. 

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Recommended Dosage: 
o 
Aspirin (ASA) 75 or 81 mg (minimum dose) to 325 mg (maximum dose) PO q.d. for at least 5 
days prior to the implant procedure 
o 
Clopidogrel/Plavix 75 mg PO q.d. for at least 5 days prior to the implant procedure 
3.8 
Implant 
3.8.1 
Implant/Procedural Pharmacotherapy 
All procedures will be performed under general anesthesia. Subjects will be anticoagulated during the 
implant procedure. Anticoagulation will be managed in accordance with site standard of care. 
3.8.2 
Implant/Procedural Steps 
As previously indicated, the Neuroform Atlas™ Stent System consists of a laser cut, nitinol, self-
expanding stent preloaded over a delivery wire inside an introducer sheath. The Neuroform Atlas™ Stent 
System is shipped with detailed written Directions for Use (DFU). Prior to enrolling and treating a 
subject in the study, all Investigators will review and understand the DFU, and will be trained by the 
Sponsor with regards to use of the Neuroform Atlas™ Stent System. 
1. Select an appropriate stent diameter based on reference vessel diameter, and select a stent length 
that is at least 8mm longer than the width of the aneurysm neck (in order to maintain a 
minimum of 4mm of stent length along the parent vessel on either side of the aneurysm neck). 
Refer to Section 8, Device Description, for additional stent sizing recommendations. 
2. Follow the procedure outlined in the DFU regarding preparation, positioning and deployment of 
the Neuroform Atlas™ Stent System. In summary, these steps are as follows: 
o The sheath and delivery wire are used to transfer the Neuroform Atlas™ stent into a 
0.0165” - 0.0170” ID microcatheter 
o After transfer, the sheath is removed from the proximal end of the delivery wire 
o The delivery wire is then used to advance the stent to the distal end of the microcatheter 
o The microcatheter, stent, and delivery wire are repositioned as a unit in order to ensure that 
the stent is located across the aneurysm 
o The stent is deployed across the neck of the aneurysm by stabilizing the delivery wire and 
withdrawing the catheter 
3. The beginning of the procedure will be defined as the point in time when the first puncture or 
incision is made. The end of the procedure will be defined as the point in time when wound 
closure is complete. If these start and stop times are not documented in the nursing or anesthesia 
records, the time stamp of the initial procedural angiogram and final procedural angiogram will 
be used. 
The following types of information will be collected regarding the implant procedure:  
• 
Date of admission 
• 
Procedure date, time, clinical site, investigator performing procedure 
• 
Duration of procedure 
• 
Device information 
o Neuroform Atlas™ Stent 
o Coil type used – brand/model 
o Adjunctive device use (e.g., balloon) 
• 
Technical success of stent assisted coiling procedure 
• 
Intra-operative AEs 

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3.8.3 
Treatment of Previously Treated Aneurysms 
Target aneurysms that have previously been treated with embolic coiling can be treated under this Study 
Protocol, assuming that the subjects involved meet all of the study inclusion/exclusion criteria as outlined 
in Section 2.6, Study Population and Source of Subjects. Subjects who have had previous stent-
assisted coiling of the target aneurysm are not eligible for inclusion in this study. 
3.8.4 
Implant of More than One Stent 
Up to two stents may be deployed in the treatment of a given aneurysm, but both stents must be 
Neuroform Atlas™ Stents. The use of other intracranial stents for treatment of the target aneurysm is not 
allowed in this study. 
3.9 
Post-Implant 
3.9.1 
Post-Implant Pharmacotherapy 
A standard antiplatelet regimen is required for post-implant use in enrolled subjects with unruptured 
intracranial aneurysms in accordance with routine clinical practice, unless it becomes contraindicated in 
an individual subject due to a medical condition. Substitutions for these medications are allowed at the 
discretion of the Investigator as long as the antiplatelet efficacies are equivalent. 
Recommended Dosage and Required/Recommended Duration: 
o 
ASA 75 or 81 mg (minimum dose) to 325 mg (maximum dose) PO q.d., required for at least 3 
months after the implant procedure; recommended for life 
o 
Clopidogrel/Plavix 75 mg PO q.d., required for at least 3 months after the implant procedure 
3.9.2 
Post-Implant Assessments 
At the Investigator’s discretion, a treated subject may be discharged from the hospital when he/she is 
clinically stable. Prior to discharge and within 72 hours of the procedure, the following assessments 
and/or procedures will be performed on all treated subjects: 
o 
Neurologic rating/grading scales including the following: 
▪ 
mRS (all subjects) 
▪ 
Hunt and Hess (for subjects who previously had a ruptured aneurysm and evidence of 
subarachnoid hemorrhage) 
o 
Assessment and documentation of any adverse events arising after the procedure but prior to 
discharge. 
At the time of discharge, designated staff at the clinical site will review the study requirements with the 
subject in order to maximize compliance with the follow-up schedule and the post-implant medication 
regimen. The staff will instruct the subject to return for follow-up assessments in accordance with the 
study event schedule outlined in Table 2, and if possible, they will establish and schedule a date for the 
first follow-up visit and/or procedure. In addition, the staff will instruct the subject to take the 
recommended antiplatelet medication, and will ask the subject to check in with the clinical site prior to 
discontinuing any antiplatelet medication in the absence of an emergency. 
3.10 
Follow Up Visits 
Enrolled and treated subjects will return for follow-up visits and collection of primary and/or secondary 
endpoint data as required at two, six, and twelve months. Long-term outcomes data will be collected at 

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two and three years post-implant. During these follow-up visits, assessments and/or procedures will be 
performed as follows: 
Two Months (60 days) ± 1 Month Post-Implant: 
o 
Neurological rating/grading scales including the following: 
▪ 
mRS (all subjects) 
▪ 
NIHSS (only if mRS score is > 0 in association with an adverse neurological event) 
o 
Angiography (MRA or DSA) - only if required per site standard of care 
o 
Assessment and documentation of any adverse events arising since discharge 
o 
Assessment of compliance to the antiplatelet regimen 
Six Months (180d) ± 1 Month Post-Implant: 
o 
Neurologic rating/grading scales including the following: 
▪ 
mRS (all subjects) 
▪ 
NIHSS (only if mRS score is > 0 in association with an adverse neurological event) 
o 
Angiography (MRA or DSA) - only if required per site standard of care 
o 
Assessment and documentation of any adverse events arising since the previous follow-up visit 
o 
Assessment of compliance to the antiplatelet regimen 
Twelve Months (365d) ± 2 Months Post-Implant: 
o 
Neurological examination (including global neurological assessments and evaluation for cranial 
nerve deficits) 
o 
Neurologic rating/grading scales including the following: 
▪ 
mRS (all subjects) 
▪ 
NIHSS (all subjects) 
▪ 
Hunt and Hess (for subjects who previously had a ruptured aneurysm and evidence of 
subarachnoid hemorrhage) 
o 
Angiography (DSA) 
NOTE:  12-month angiography (DSA) is used to assess the primary endpoint and is required for 
all subjects 
o 
Assessment and documentation of any adverse events arising since the previous follow-up visit 
o 
Assessment of compliance to the antiplatelet regimen 
o 
Quality of Life assessment 
Two Years (730d) ± 6 Months Post-Implant: 
o 
Neurological examination (including global neurological assessments and evaluation for cranial 
nerve deficits, if applicable) 
o 
mRS assessment 
o 
Radiological imaging (MRA, DSA or CTA), if performed per institutional standard of care 
o 
Assessment and documentation of any adverse events arising since the previous follow-up visit, 
including all new and ongoing adverse events 

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o 
Assessment of antiplatelet regimen 
o 
Retreatment assessment   
Three Years (1095d) ± 6 Months Post-Implant: 
o 
Neurological examination (including global neurological assessments and evaluation for cranial 
nerve deficits, if applicable) 
o 
mRS assessment 
o 
Radiological imaging (MRA, DSA or CTA), if performed per institutional standard of care 
o 
Assessment and documentation of any adverse events arising since the previous follow-up visit, 
including all new and ongoing adverse events 
o 
Assessment of antiplatelet regimen 
o 
Retreatment assessment  
NOTE:  Two- and 3-year office visits with neurological examination are required. If the 3-year visit 
window has elapsed at the initiation of the PAS, subjects will be asked to return for at least 1 follow-up 
visit. In the event a subject refuses to return for an office visit, effort should be made to conduct 
telephone follow-up to complete an adverse event assessment and obtain mRS scores. 
 
3.11 
Unscheduled Visits 
Imaging performed in response to an adverse event will be documented in the case report forms. These 
images will be shared with the Imaging Core Lab, and copies of the images will be provided to the 
Sponsor so that CEC review and event adjudication can be facilitated. If a subject is suspected of having 
a stroke, it is recommended that an imaging study be performed within 24 hours of the onset of 
symptoms in order to confirm, and to evaluate whether the stroke is/was ischemic or hemorrhagic in 
nature. In addition, a neurological examination and/or an assessment using neurologic rating/grading 
scales (mRS, NIHSS, Hunt and Hess) should be performed as required in order to determine the severity 
of the stroke. 
If a subject presents with an adverse event, he/she will receive appropriate treatment per site standard of 
care. If the subject’s condition precludes him/her from undergoing angiography or any other evaluation 
specified in the protocol, the Investigator should document whether a stable clinical endpoint has been 
reached, or whether the subject’s status is associated with an adverse event possibly related to the device 
or procedure. All efforts will be made to retain the subject for safety follow up. If the subject is 
withdrawn from the study, reasons for the subject’s inability to continue with study evaluations will be 
documented. 
4 
Statistical Methods and Considerations 
4.1 
Trial Success/Failure Criteria  
This is a single arm trial of the Neuroform Atlas™ Stent System in subjects with wide neck aneurysms 
who will receive stent-assisted coiling with any approved bare metal embolic coils. Up to 360 subjects 
with wide neck saccular aneurysms who meet all eligibility criteria will be enrolled. The primary 
effectiveness endpoint is complete occlusion of the targeted lesion at 12 months, and the related study 
success criterion is to demonstrate that the lower bound of the 95% exact CI observed  rate of complete 
occlusion at 12 months is greater than 50% in both the anterior and posterior circulation cohorts. The 
primary safety endpoint is any major ipsilateral stroke or neurological death within 12 months, and the 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 33 of 74 
related study success criteria are to demonstrate that the rate of primary safety events is less than 20% in 
the anterior circulation cohort, and less than 25% in the posterior circulation cohort. 
4.2 
Sample Size Estimate and Justification 
Anterior Circulation Cohort: 
A sample size of up to 180 subjects with intracranial aneurysms in the distal anterior circulation has been 
selected for this study in order to provide 153 evaluable subjects at 12 months, with an estimated 15% 
attrition rate. Assuming an effectiveness primary endpoint response rate of 62% (per the findings of a 
meta-analysis of Neuroform stent literature as performed by King et al[59]), the expected lower bound of 
the exact binomial two-sided 95% confidence interval around the success rate is greater than 50%. 
Assuming a safety primary endpoint rate of 8%, the expected upper bound of the exact binomial two-
sided 95% confidence interval around the success rate is less than 20%. A sample size of 153 evaluable 
subjects provides 85% power to demonstrate the effectiveness endpoint, and a power of approximately 
99% to successfully demonstrate the safety endpoint given the observed rates stated above. The 
combined probability of the two endpoints is (.85) x (.99) = .842. 
Posterior Circulation Cohort: 
Separate analyses of these cohort data will be performed to support an indication for use in the posterior 
circulation. 
A sample size of up to 180 subjects with intracranial aneurysms in the posterior circulation (including 
vertebral, basilar and posterior cerebral arteries) will also be enrolled in order to provide 153 evaluable 
subjects at 12 months, with an estimated 15% attrition rate. While the safety endpoint rate for posterior 
circulation subjects may be higher than that for the anterior circulation subjects, that rate is not expected 
to exceed 12%. Assuming a safety primary endpoint rate of 12%, the expected upper bound of the exact 
binomial two-sided 95% confidence interval around the success rate is less than 25%. A sample size of 
153 evaluable subjects provides a power of approximately 99% to successfully demonstrate the safety 
endpoint given the observed rates stated above. Based on outcomes in the MAPS study, the effectiveness 
rate for posterior circulation subjects is expected to be very close to that of anterior circulation subjects. 
Therefore, the statement of power to demonstrate effectiveness for a sample size of 153 evaluable 
anterior circulation subjects also holds for a sample size of 153 evaluable posterior circulation subjects. 
For the posterior circulation cohort, a Bayesian adaptive study design (“Goldilocks” approach) providing 
for interim analyses of accumulated data will be used to select the final sample-size. The first interim 
data analysis will occur once 100 posterior circulation subjects have been enrolled. Based on enrollment 
rates and the frequency of disease in the posterior circulation, at the time this interim analysis is 
performed it is estimated that primary endpoint data will be available for approximately 39 – 63 posterior 
circulation subjects. If, at an interim analysis, there is at least a 95% predictive probability of observing a 
true rate of complete occlusion that is higher than 50%, enrollment in the posterior circulation cohort will 
be stopped early for success. The maximum sample-size for the posterior circulation cohort will be no 
more than 180 subjects. 
4.3 
Eligibility of Subjects, Exclusions and Missing Data 
All efforts will be made to avoid any missing data, especially data related to the primary endpoints. 
Subjects who suffer neurological death prior to one year follow up will be imputed as Raymond 3 (the 
worst case) in the analysis of the primary effectiveness endpoint.  Regression methods will be used to 
impute missing endpoint data.  For either the safety endpoint or the effectiveness endpoint, five separate 
imputed data sets will be constructed in this manner.  Inferences will then be completed using pooled 
estimates across the five data sets.  In the event that no predictor variables can be found for the regression 
models, missing data will be imputed by a random draw from observed data for patients with similar 
baseline characteristics (e.g., gender, aneurysm location, race, etc.) as those with the missing data. 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 34 of 74 
4.4 
Analysis Populations 
ITT (Intent to Treat): All subjects who have signed the Informed Consent Form for this trial, and in 
whom the Neuroform Atlas™ Stent implantation procedure has been attempted (i.e., a component of the 
stent system was introduced into the body). 
mITT (Modified Intent to Treat): All subjects who have signed the Informed Consent Form for this 
trial, and in whom the Neuroform Atlas™ Stent has been successfully implanted. 
PP (Per Protocol): All subjects who have signed the Informed Consent Form for this trial, who have had 
the Neuroform Atlas™ Stent successfully implanted, and who have not been the subject of any major 
protocol deviations. 
Enrolled Not Treated: All subjects who have signed the Informed Consent Form for this trial, but in 
whom no component of the Neuroform Atlas™ Stent System has ever been introduced into the body as 
part of an implantation procedure.  
PAS ITT (ITT for the PAS): All subjects who have signed the Informed Consent Form for this trial, and 
in whom the Neuroform™ Atlas Stent has been successfully implanted. This cohort is identical to the 
mITT cohort. 
PAS mITT (Modified Intent to Treat in PAS): All mITT subjects who have not withdrawn, died, or 
refused follow-up.  
The primary safety and effectiveness analyses will be performed on the mITT population. The 95% 
Confidence Interval (CI) for each endpoint will be calculated using the exact binomial distribution. In 
addition, safety data will include any adverse events reported to occur among ITT subjects in whom a 
Neuroform Atlas™ Stent implantation procedure was attempted but did not successfully occur. For long-
term follow-up, all analyses completed for the PAS mITT cohort will also be completed for the PAS ITT 
cohort for comparison 
 
4.5 
Primary Endpoints Justification 
4.5.1 
Justification for Effectiveness Criteria 
As is evident from the literature, the treatment of wide neck aneurysms with embolic coiling is generally 
associated with low complete occlusion rates and a high incidence of recanalization.  Surgical clipping is 
widely perceived to be associated with high occlusion rates but greater risk of major morbidity and 
mortality events. However, the reliability of published data on occlusion rates following surgical clipping 
has recently been called into question. In a meta-analysis of surgical treatment of unruptured intracranial 
aneurysms conducted by Kotowksi et al—which included 60 studies published between 1990 and 2011 
that described outcomes among 9,845 subjects with 10,845 aneurysms—the authors reported that 
occlusion outcomes were not reported for 82.2% of the aneurysms and recommended against using the 
results of these studies to formulate treatment plans.[66] Quality published data on surgical clipping of 
wide neck aneurysms are not available. 
Certain aneurysms are unable to achieve treatment success by surgery or by coiling alone.  Treatment 
efficacy increases (increased occlusion, decreased recanalization) with the use of adjunctive devices such 
as stent assisted coiling as well as with more favorable aneurysm morphologies. Effectiveness outcomes 
based on occlusion rates, as reported in the literature, can vary widely depending on the degree of 
heterogeneity in the study population (which is often very high) and the methods of reporting outcomes 
(e.g., immediate vs. follow-up angiography results). 
Data from the MAPS Trial 
The MAPS Trial was a multinational, multicenter, randomized controlled trial conducted at 43 
investigational sites and into which 626 patients with either ruptured or unruptured intracranial 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 35 of 74 
aneurysms at any location (ranging in size from 4-20 mm) were enrolled and treated using embolic 
coils.[63] The original purpose of the MAPS non-inferiority trial was to compare effectiveness of Matrix-2 
biopolymer–modified coils with effectiveness of bare metal coils when using a composite clinical 
outcome measure (i.e., Target Aneurysm Recurrence [TAR]) as the primary study endpoint. Secondary 
effectiveness endpoints included angiographic occlusion (as assessed by an independent Core Laboratory 
using the modified Raymond Scale) and clinical outcomes (as assessed using the modified Rankin Scale) 
(mRS). At 12-month follow-up (± 3months), it was shown that there was no significant difference in 
angiographic occlusion rates or other effectiveness outcomes between the two groups. Similar findings 
have been reported elsewhere. In another large-scale randomized controlled trial of endovascular coiling, 
Molyneux et al. reported no significant difference in angiographic occlusion rates between patients 
randomized to treatment with polymer-loaded coils versus those randomized to treatment with bare metal 
coils.[67] In a recent systematic review/meta-analysis designed to assess differences in reported 
unfavorable angiographic outcomes for coiled cerebral aneurysms as a function of coil type, it was 
similarly demonstrated that across 82 studies, there were no significant differences based on coil type.[68] 
A large proportion of patients enrolled in the MAPS trial were similar to the study population for which 
use of the Neuroform Atlas Stent System is intended. When key screening criteria that will be used to 
enroll patients into the ATLAS IDE trial were applied to the MAPS database, a total of 247 patients who 
underwent coiling alone were available for comparative analysis. These key criteria included:  a) 
inclusion of wide-neck aneurysms (defined as being aneurysms having a neck width ≥ 4 mm or a dome-
to-neck ratio < 2) located in the posterior or anterior “non-petrous” circulation (i.e., excluding the petrous 
Internal Carotid Artery [ICA] to superior hypophyseal ICA region); b) exclusion of patients with a 
baseline Hunt and Hess score ≥ 3; and c) exclusion of patients with a baseline mRS score ≥ 4. In the 
MAPS study, of the 247 wide-neck aneurysms that met these criteria, 205 (83%) were located in the 
anterior non-petrous circulation and 42 (17%) were located in the posterior circulation. Within this 
subgroup, twelve-month (± 3 months) angiographic data were available for 197/247 patients (80%) and 
were reviewed by the independent Core Laboratory that was used for the MAPS study (i.e. the 
University of California at San Francisco).  
As the patient population comprising this subgroup closely matches the patient population to be enrolled 
in the ATLAS IDE trial, and the prospectively defined secondary endpoints used in the MAPS trial are 
similar to the effectiveness endpoints to be used in the ATLAS IDE trial, this data set of 247 patients 
represents a valid, reasonable and homogenous historical control group upon which performance goals 
can be based. Further, the major findings from the MAPS trial and other studies that examined the effect 
of coil type on angiographic outcome justify and support the inclusion of MAPS patients treated with 
either polymer-coated or bare metal coils in the comparative dataset. 
Table 3 provides a summary of angiographic outcomes in the above-described MAPS patient cohort, 
comparing immediate and 12 (± 3) month occlusion outcomes by aneurysm location. At 12 (± 3) month 
follow-up, total occlusion rates were slightly less than 40% and there was no significant difference in 
outcomes between groups of patients with anterior non-petrous and posterior circulation aneurysms. 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 36 of 74 
Table 3 - MAPS Cohort - Angiographic Outcomes as Assessed by an Independent Core 
Lab 
Modified Raymond Scale – Class I 
Wide Neck Aneurysms [1,2] 
(N =247) 
P-value 
Anterior Non-petrous 
(n =205) 
Posterior 
(n =42) 
12 (± 3) month FU or Re-intervention 
37.2% (61/164) 
36.4% (12/33) 
0.93 
[1] Neck width ≥ 4mm or dome-to-neck ratio < 2 
[2] Excludes subjects with a pre-procedure Hunt and Hess score ≥ 3; excludes subjects with a pre-
procedure mRS score ≥ 4 
Data from the Scientific Literature 
A comprehensive search of current scientific literature was conducted in order to identify published 
articles suitable for inclusion in a meta-analysis of wide neck aneurysm treatment outcomes. To be 
included, each published article had to meet the following key criteria:  (1) English language; (2) 
published in 2000 or later; (3) contained data regarding safety, performance, and/or effectiveness 
involving the treatment of wide neck intracranial aneurysms in a clinical setting, or analyses of data 
maintained in registries and/or institutional databases; (4) contained data derived from a minimum 
sample size of n = 5; (5) could not be superseded by a publication with the same sample group, or 
contribute to a later publication including data from the same study (unless the article addressed a 
different objective); (6) contained data for complete occlusion (Raymond Score 1) rate as assessed by 
angiography at follow-up; (7) included literature containing data for balloon-assisted coiling; (8) 
included literature containing data for coiling alone; and (9) contained data from clinical and 
angiographic follow-up ranging from 6 to 18 months post-treatment. An important exclusion criterion 
was the absence of appropriate clinical or angiographic follow-up data (e.g., no long-term follow-up, or 
no Raymond scores reported).  
The literature search yielded 339 articles using the search terms “wide neck aneurysms and occlusion”. 
Of these 339 articles, 329 were excluded for failing to meet the pre-determined criteria for inclusion. An 
additional relevant article by Hetts et al[26] was included as it contained a subset of wide neck aneurysms 
treated in the Stryker sponsored MAPS Trial. This yielded 11 published articles whose data could be 
assessed via a meta-analysis in order to derive effectiveness performance goals for both the anterior and 
posterior cohorts.[26, 30, 31, 37-42, 69, 70] Stent assisted coiling data from two of these articles (Hetts et al.[26] 
and Chalouhi et al.[38]) were included in this meta-analysis. A summary of effectiveness data contained in 
these 11 articles is presented in Table 4. 
 

 
SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL Aneurysms with the Neuroform Atlas™ Stent 
System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 37 of 74 
Table 4 - Summary of Effectiveness Data Derived from Literature Search 
 
Reference
N
Neck 
<4mm
Neck 
≥4mm
Dome-to-
Neck Ratio Ruptured
Location
Coiling
BAC
SAC
Anz 
Coiled
(Anz at 
FUP)
Immediate 
Complete 
Occlusion
ALL
Immediate 
Complete 
Occlusion
WNA
Complete 
Occlusion 
at
Follow-Up
ALL
Complete 
Occlusion 
at
Follow-Up
WNA
Recanaliz n/
Retreatment
ALL
Recanaliz n/
Retreatment
WNA
Time to 
Follow-Up 
Angio
Mean 
(Range)
2000
Aletich
JNS [37]
75 anz
72 pts
52/75 
(69%) 
23/75 
(31%)
53/75 (71%) 
= <2
22/75 (29%) 
= ≥2
20/75
(27%)
75% Ant
25% Post
100%
BAC
66 anz
(64 anz)
N/A
17/66
(26%)
N/A
24/64
(38%)
N/A
N/A
11.2 mo
(6 - 29 mo)
2001
Cottier
AJNR [39]
45 anz
44 pts
27/44 
(61%)
95% Ant
5% Post
100%
BAC
45 anz
(45 anz)
N/A
31/45
(69%)
N/A
30/45
(67%)
N/A
N/A
16 mo
(3 mo - 5 yr)
2001
Nelson
AJNR [41]
22 anz
22 pts
9/22 (41%)
100% Ant
100%
BAC
22 anz
(20 anz)
N/A
15/22
(68%)
N/A
17/20
(85%)
N/A
0/20
(0%)
19 mo
(12 - 30 mo)
2002
Lozier
Stroke [30]
495 anz
489 pts
(meta-
analysis of 
12 studies)
40%
19%
100% Post
100%
Coiling
483 anz
(All = 208 
anz; WNA 
= 112 anz)
217/456
(48%)
N/A
93/208
(45%)
26/112
(23%)
46/208
22%
32/112
(29%)
16.8 mo (mean 
for 6/12 
studies) and 
26.1 mo (mean 
for 6/12 
studies) 
2006
Niimi
Stroke [31]
74 anz
70 pts
43/74
58%
31/74 
(42%)
80% Ant
20% Post
79%
Coiling
16%
BAC
5%
SAC
All = 74 
anz; WNA 
= 31 anz
(All = 47 
anz; WNA 
= 25 anz)
13/74
(18%)
4/31
(13%)
10/47
(21%)
5/25
(20%)
27/47
(57%)
18/25
(72%)
12 mo
(4d - 34 mo)
2013
Chalouhi
AJNR [38]
101 pts 
total; 32 
BAC 
21/32 
(66%)
81% Ant
19% Post
32/101 
(32%) BAC
32 anz
(32 anz)
N/A
11/32
(34%)
N/A
16/32
(50%)
N/A
5/32
(16%)
6.5 mo
(3 - 36 mo)
2013
Chalouhi
AJNR [38]
101 pts 
total; 69 
SAC
8/69
(12%)
84% Ant
16% Post
69/101 
(68%)
SAC
69 anz
(69 anz)
N/A
22/69
(32%)
N/A
52/69
(75%)
N/A
3/69
(4%)
8.0 mo
(5 - 48 mo)
100% Wide-neck
100% Wide-neck anz
100% Wide-neck anz
60% Wide-neck anz
10/74 (14%) = Small wide-
neck
20/74 (27%) = Large 
(assumed to be wide-
neck)
1/74  (1%) = Giant 
(assumed to be wide-
neck)
100% Wide-neck

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL Aneurysms with the Neuroform Atlas™ Stent 
System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 38 of 74 
 
N = sample size; BAC = balloon-assisted coiling; SAC = stent assisted coiling; Anz= aneurysm; FUP = follow-up; ALL = all aneurysms studied; WNA = wide neck aneurysm; Angio = angiography/angiogram; pts = 
patients; ant = anterior circulation; post = posterior circulation; N/A = not available; mo = months; yr = years; PComA = posterior communicating artery; AcomA = anterior communicating artery; MCA = middle cerebral 
artery; Bifurcn = bifurcation; Unk = unknown 
Reference
N
Neck 
<4mm
Neck 
≥4mm
Dome-to-
Neck Ratio Ruptured
Location
Coiling
BAC
SAC
Anz 
Coiled
(Anz at 
FUP)
Immediate 
Complete 
Occlusion
ALL
Immediate 
Complete 
Occlusion
WNA
Complete 
Occlusion 
at
Follow-Up
ALL
Complete 
Occlusion 
at
Follow-Up
WNA
Recanaliz n/
Retreatment
ALL
Recanaliz n/
Retreatment
WNA
Time to 
Follow-Up 
Angio
Mean 
(Range)
2014
Hetts
AJNR [26]
361 pts 
total; 224 
pts coiled
None
N/A
224/361 
(62%) 
coiling
All = 224 
anz; WNA 
= 73 anz
(All = 180 
anz; WNA 
= 59 anz)
76/224
(34%)
20/73
(27%)
80/180
(44%)
16/59
(27%)
19/224
(8%)
10/73
(14%)
Clinical  =  1yr, 
2yr
Angio = 12 ± 
3mo
2014
Hetts
AJNR [26]
361 pts 
total; 137 
pts SAC
None
N/A
137/361 
(38%) SAC
All = 137 
anz SAC; 
WNA = 85 
anz SAC 
(All = 114 
anz; WNA 
= 70 anz) 
29/137
(21%)
16/85
(19%)
59/114
(52%)
32/70
(46%)
12/137
(9%)
12/85
(14%)
Clinical  =  1yr, 
2yr
Angio = 12 ± 
3mo
2014
Liu
J Clin 
Neurosci [69] 
235 anz
235 pts 
with coiling
(& 56 anz
56 pts 
SAC)
165/235 
(70%)
100% PComA
81%
Coiling
19%
SAC
235 anz
(203 anz)
N/A
83/235
(35%)
N/A
103/203
(51%)
N/A
57/203
(28%)
13.2 ± 9.5 mo
= mean angio 
FUP
2014
Peterson 
Neurosurg 
[42] 
35 anz
35 pts with 
BAC;
(& 71 anz
71 pts with 
SAC)
None
89% Ant
11% Post
35/106
(33%) = 
BAC;
71/106
(67%) = 
SAC
35 anz
(35 anz)
N/A
18/35
(51%)
N/A
19/35
(54%)
N/A
2/35
(6%)
Angio FUP at
6mo and 12 mo
2015
Song
J Korean 
Neurosurg Soc 
[70]
53 anz
53 pts
28/53 
(53%)
17% AComA
9% MCA Bifurc n
8% Cavernous
26% Paraclinoid
19% PComA
8% Basilar Tip
13% Unk
85%
Coiling
15%
SAC
45 anz 
coiling 
alone; 8 
anz SAC
(45 anz 
coiling 
alone; 8 
anz SAC)
N/A
25/45
(56%)
N/A
20/45
(44%)
N/A
15/45
(42%) = major 
recurrence; 
7/45 (16%) = 
minor 
recurrence; 
8/53 (15%) = 
retreatment  
Angio FUP
37.9 mo
(12 - 120 mo)
2011
Modi
Interv 
Neuroradiol 
[40]
11 anz
11 pts
6/11 (55%)
64% Ant
36% Post
100%
BAC
11 anz
(11 anz)
N/A
8/11
(73%)
N/A
8/11
(73%)
N/A
1/11
(9%)
11 mo
(6-20 mo)
Mostly Wide-neck
(Mean neck width for coiled anz = 
4.08 ± 2.85mm)
100% Wide-neck
100% Wide-neck
100% Wide-neck
73/224 (33%) were wide-neck anz
85/137 (62%) were wide-neck anz

 
SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 39 of 74 
 
Random Effect Model Meta-Analyses 
Two random effect model meta-analyses were performed in order to determine overall complete 
occlusion rates of treated aneurysms at final follow-up. One meta-analysis was performed using complete 
occlusion data from published literature only, with data from the article by Hetts et al[26] being used as 
data from the MAPS study. This meta-analysis included data for coiling alone, balloon-assisted coiling, 
and stent assisted coiling, with the latter coming from articles by Hetts et al[26] and Chalouhi et al[38]. For 
this meta-analysis, data specific to wide neck aneurysms yielded an average weighted complete occlusion 
rate of 49% (Figure 3). The second meta-analysis was performed using complete occlusion data from 
published literature for coiling and balloon assisted coiling in combination with complete occlusion data 
for coiling only subjects from the previously described MAPS wide neck aneurysm patient cohort (N = 
247). For this meta-analysis, data specific to wide neck aneurysms yielded an average weighted compete 
occlusion rate of 47% (Figure 4). Given the findings of these two meta-analyses, a historical control rate 
of 50% for complete occlusion is conservative and is justified. 
 
Figure 3 - Complete Occlusion Rates, Wide Neck Intracranial Aneurysms Only, MAPS 
Data from Hetts et al., Includes Stent Assisted Coiling Data from Hetts et al. and 
Chalouhi et al. 
 
 
 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 40 of 74 
 
 
Figure 4 - Complete Occlusion Rates, Wide Neck Intracranial Aneurysms Only, MAPS 
Data from MAPS Dataset, Includes Coiling or Balloon Assisted Coiling Data Only 
4.5.2 
Justification of Safety Criteria 
Data from the MAPS Trial 
As presented in Table 5, analysis of the 12-month (± 3 months) safety data from the previously described 
MAPS wide-neck aneurysm patient cohort (N = 247) showed that the overall stroke rate was 6.9% 
(17/247), and in the anterior and posterior subgroups, the stroke rates were 5.9% (12/205) and 11.9% 
(5/42), respectively (P = 0.18). There was one neurological death, which occurred in the anterior 
circulation subgroup (0.5%). When stroke and neurological death rates were combined, the overall 
incidence rate was 7.3% (18/247). 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 41 of 74 
Table 5 - MAPS Cohort - Primary Safety Outcomes 
Primary Safety Outcomes 
Wide Neck Aneurysms [1,2] 
(N =247) 
P-value 
Anterior Non-petrous 
(n =205) 
Posterior 
(n =42) 
Stroke [3] 
5.85% (12/205) 
11.90% (5/42) 
0.1787 
Neurological Death 
0.49% (1/205) 
0.00% (0/42) 
1.0000 
Composite of Stroke and 
Neurological Death 
5.85% (12/205) 
11.90% (5/42) 
0.1787 
[1] Neck width ≥ 4mm or dome-to-neck ratio < 2 
[2] Excludes subjects with a pre-procedure Hunt and Hess score ≥ 3; excludes subjects with a pre-
procedure mRS score ≥ 4 
[3] Includes strokes of any type or severity 
Safety data from the MAPS wide neck aneurysm patient cohort are consistent with the primary safety 
endpoints that have been chosen for each cohort in this study. Assuming a primary safety endpoint of 8% 
in the anterior circulation cohort and 12% in the posterior circulation cohort, the upper limit of the 95% 
confidence interval of the proportion of subjects who achieve the primary safety endpoint is <20.0% and 
<25.0% in each cohort, respectively. 
Data from the Scientific Literature 
The 11 articles located via the comprehensive literature search that was performed to locate relevant 
historical effectiveness data were likewise used to develop objective performance benchmarks against 
which the safety results of this study could be measured.[26, 30, 31, 37-42, 69, 70] A summary of safety data 
derived from these articles is presented in Table 6. 
A review of these articles yielded ranges for procedural complication rates (1% - 36%), procedural 
morbidity (mRS ≥3) rates (0% - 17%), procedural neurologic mortality rates (0% - 9%), stroke rates 
through follow-up (0% - 12%), long-term morbidity (mRS ≥3) rates (2% - 13%), and long-term 
neurologic mortality rates (2% - 10%) for all aneurysms that were treated using embolic coiling, balloon-
assisted embolic coiling, or stent assisted coiling. For the sub-set of wide neck aneurysms that were 
treated using embolic coiling, balloon-assisted embolic coiling, or stent assisted coiling, long-term 
morbidity and mortality rates ranged from 0% - 25%. 
Again, given these findings, the success criteria for safety that have been chosen for this study (i.e., upper 
limit of the 95% confidence interval of the proportion of subjects with anterior or posterior circulation 
aneurysms who achieve the primary safety endpoint is < 20 % and <25%, respectively) are within range 
and appropriate. 
 

 
SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL Aneurysms with the Neuroform Atlas™ Stent 
System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 42 of 74 
Table 6 - Summary of Safety Data Derived from Literature Search 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Reference
N
Neck 
<4mm
Neck 
≥4mm
Dome-to-Neck Ratio
Ruptured
Location
Coiling
BAC
SAC
Procedural Complications
Procedural 
Morbidity
(mRS ≥3)
Procedural 
Neurologic 
Mortality
Stroke
(Procedure Thru 
Follow-up)
Long-Term 
Morbidity
(mRS ≥3)
Long-Term 
Neurologic 
Mortality
Long-Term 
Morbidity & 
Mortality for 
WNA Subset
Follow-Up 
Period
Mean (Range)
2000
Aletich
JNS [37]
75 anz
72 pts
52/75 
(69%) 
23/75 
(31%)
53/75 (71%) = <2
22/75 (29%) = ≥2
20/75
(27%)
75% Ant
25% Post
100%
BAC
7/72 
(10%);
2 = anz rupture
1 = TE stroke
4/72
(6%) 
3/72
(4%)
2/72
(3%)
N/A
N/A
7/72
(10%)
 11.2 mo
 (6-29 mo)
2001
Cottier
AJNR [39]
45 anz
44 pts
27/44 
(61%)
95% Ant
5% Post
100%
BAC
2/44
(5%);
2 = TE
0/44
(0%)
0/44
(0%)
0/44
(0%)
N/A
N/A
N/A
16 mo
(3 mo - 5 yr)
2001
Nelson
AJNR [41]
22 anz
22 pts
9/22 (41%)
100% Ant
100%
BAC
7/22
(32%);
1 = minor stroke
2 = groin hematomas
1 = groin pseudoanz
1 = TE
2 = TIA (1 in pt who also 
had a groin hematoma) 
1/22
(5%)
2 /22
(9%)
1/22
(5%)
N/A
N/A
2/22
(5%)
angio 19 mo
clinical 29 mo
2002
Lozier
Stroke [30]
495 anz
489 pts
(meta-
analysis of 
12 studies)
40%
19%
100% Post
100%
Coiling
62/489
(13%);
13 = rupture 
14 = coil protrusion
27 = thrombosis
5 = embolism
3 = dissection
25/489
(5%)
7/489
(1% 
procedural);
33/489
(7% at 30 days)
N/A
24/450
(5%)
44/450 (10%)
N/A
16.8 mo (mean 
for 6/12 
studies) and 
26.1 mo (mean 
for 6/12 
studies) 
2006
Niimi
Stroke [31]
74 anz
70 pts
43/74
58%
31/74 
(42%)
80% Ant
20% Post
79%
Coiling
16%
BAC
5%
SAC
12/70
(17%); 
4 = TE events
4 = coil protrusion
1 = thrombus, 
extravasation (death)
3  = asymptomatic
1/70
(1%)
1/70
(1%)
2/70
(3%);
1 = TE
1 = delayed rupture
8/62
(13%)
3/62
(5%)
N/A
15 mo
(1-37 mo)
2013
Chalouhi
AJNR [38]
101 pts 
total; 32 
BAC 
21/32 
(66%)
81% Ant
19% Post
32/101 (32%) BAC
3/32
(9%)
1 = rupture
1 = thrombus
1 = infarct
1/32
(3%)
N/A
1/32
(3%)
N/A
N/A
1/32
(3%);
permanent 
morbidity
Angio FUP
6.5 mo
(3 - 36 mo)
2013
Chalouhi
AJNR [38]
101 pts 
total; 69 
SAC
8/69
(12%)
84% Ant
16% Post
69/101 (68%)
SAC
4/69
(6%)
1 = rupture
2 = clinical infarct
1 = silent infarct
2/69
(3%)
N/A
3/69
(4%)
N/A
N/A
2/69
(3%);
permanent 
morbidity
Angio FUP
8.0 mo
(5 - 48 mo)
100% Wide-neck
100% Wide-neck
100% Wide-neck anz
100% Wide-neck anz
60% Wide-neck anz
10/74 (14%) = Small wide-neck
20/74 (27%) = Large (assumed to 
be wide-neck)
1/74  (1%) = Giant (assumed to be 
wide-neck)

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL Aneurysms with the Neuroform Atlas™ Stent 
System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 43 of 74 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
N = sample size; BAC = balloon-assisted coiling; SAC = stent-assisted coiling; WNA = wide neck aneurysms; anz = aneurysms; pts = patients; Ant = anterior circulation; Post = posterior circulation; TE = thromboembolic; 
N/A = not available; mo = months; yr = years; TIA = transient ischemic attack; Angio = angiography/angiogram; FUP = follow-up; mm = millimeters; PComA = posterior communicating artery; AcomA = anterior communicating 
artery; MCA = middle cerebral artery; Bifurcn = bifurcation; Unk = unknown; FU = follow-up 
Reference
N
Neck 
<4mm
Neck 
≥4mm
Dome-to-Neck Ratio
Ruptured
Location
Coiling
BAC
SAC
Procedural Complications
Procedural 
Morbidity
(mRS ≥3)
Procedural 
Neurologic 
Mortality
Stroke
(Procedure Thru 
Follow-up)
Long-Term 
Morbidity
(mRS ≥3)
Long-Term 
Neurologic 
Mortality
Long-Term 
Morbidity & 
Mortality for 
WNA Subset
Follow-Up 
Period
Mean (Range)
2014
Hetts
AJNR [26]
361 pts 
total; 224 
pts coiled
None
N/A
224/361 (62%) 
coiling
All coiled anz
 10/224
(5%) 
Coiled WNA
1/73
(1%)
N/A
N/A
All coiled anz
5/224
(2%) = ischemic 
stroke;
1/224
(<1%) = delayed 
rupture 
Coiled WNA
 3/73
(4%) = ischemic 
stroke;
0/73
(0%) = delayed 
rupture
5/202
(3%)
4/202
(2%)
1/66
(2%) 
morbidity;
0/66
(0%) 
mortality
Clinical  =  
1yr, 2yr
Angio = 12 ± 
3mo
2014
Hetts
AJNR [26]
361 pts 
total; 137 
pts SAC
None
N/A
137/361 (38%) SAC
All SAC anz
9/137
(7%)
SAC WNA
3/85
(4%)
N/A
N/A
All SAC anz
12/137
(9%) = ischemic 
stroke;
4/137
(3%) = delayed
rupture
SAC WNA
10/85
(12%) = ischemic 
stroke;
2/85
(2%) = delayed 
rupture
2/128
(2%)
3/128
(2%)
0/73
(0%)
morbidity;
0/73
(0%)
mortality
Clinical  =  
1yr, 2yr
Angio = 12 ± 
3mo
2014
Liu
J Clin Neurosci [69] 
235 anz
235 pts with 
coiling
(& 56 anz
56 pts SAC)
165/235 
(70%)
100% PComA
81%
Coiling
19%
SAC
27/235
(11%);
9 = TE
 5 = rupture
13 = coil protrusion
39/235
(17%);
oculomotor nerve 
paresis
N/A
N/A
N/A
N/A
53/211
(25%)
13.3 ± 9.3 mo
for 211/235
2014
Peterson 
Neurosurg [42] 
35 anz
35 pts with 
BAC;
(& 71 anz
71 pts with 
SAC)
None
89% Ant
11% Post
35/106
(33%) = BAC;
71/106
(67%) = SAC
3/35
( 9%) = minor
complications (groin 
complications, 
asymptomatic vessel 
dissection)
0/35
(0%)
0/35
(0%)
0/35
(0%)
N/A
N/A
0/35
(0%)
Mean 24.5 mo;
6 and 12 mo 
angios
2015
Song
J Korean Neurosurg 
Soc [70] 
53 anz
53 pts
28/53 
(53%)
17% AComA
9% MCA Bifurc n
8% Cavernous
26% Paraclinoid
19% PComA
8% Basilar Tip
13% Unk
85%
Coiling
15%
SAC
6/53
(11%);
2 = TE (1 resolved, 1 
infarction)
2 = aneurysm rupture
1 = occluded ophthalmic
(flow restored at FU)
1 = coil migration
1/53
(2%)  
0/53
(0%)
1/53
(2%);
 cerebral infarction  
N/A
N/A
0/53
(0%)
Angio
37.9 mo
(12 - 120 mo)
2011
Modi
Interv Neuroradiol 
[40]
11 anz
11 pts
6/11 (55%)
64% Ant
36% Post
100%
BAC
4/11
(36%);
3 = local thrombus
1 = dissection
1 = groin hematoma
0/11
0%
0/11
0%
0/11
(0%)
N/A
N/A
0/11
(0%)
11 mo
(6-20 mo)
100% Wide-neck
85/137 (62%) were wide-neck anz
73/224 (33%) were wide-neck anz
Mostly Wide-neck
(Mean neck width for coiled anz = 4.08 ± 
2.85mm)
100% Wide-neck
100% Wide-neck

 
SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 44 of 74 
4.6 
Statistical Analysis 
All analyses will be performed using SAS, version 9.4 or higher. Some interim analyses and figures may 
require the use of R 3.2.3 or above. 
Primary analysis will initially be carried out when data from 153 evaluable subjects from the mITT 
group of anterior circulation subjects are available. 
Due to the substantially lower incidence of aneurysms in the posterior circulation (approximately 15-
20% of diagnosed cases), the subject enrollment period for the posterior circulation cohort will be much 
longer in duration versus that of the anterior circulation cohort. As a result, analysis of data from the 
posterior circulation cohort will be completed after results for the anterior circulation subjects have 
already been submitted for review by the FDA, and data from that analysis will be used to support an 
expanded indication for use of the Neuroform Atlas™ Stent System, i.e. an indication for use in the 
posterior circulation. For the posterior circulation cohort, a Bayesian adaptive study design (“Goldilocks” 
approach) providing for interim analyses of accumulated data will be used to select the final sample-size. 
The first interim data analysis will occur once 100 posterior circulation subjects have been enrolled. 
Based on enrollment rates and the frequency of disease in the posterior circulation, at the time this 
interim analysis is performed it is estimated that primary endpoint data will be available for 
approximately 39 – 63 posterior circulation subjects. If, at an interim analysis, there is at least a 95% 
predictive probability of observing a true rate of complete occlusion that is higher than 50%, enrollment 
in the posterior circulation cohort will be stopped early for success. The maximum sample-size for the 
posterior circulation cohort will be no more than 180 subjects. 
Analyses for both cohorts will be performed by constructing two-sided 95% confidence intervals about 
the estimates of the percentage of subjects with complete aneurysm occlusion and the percentage of 
subjects experiencing a major ipsilateral stroke or neurological death using the exact binomial (Clopper-
Pearson) method. For the effectiveness endpoint of total occlusion, the lower bound of this confidence 
interval will be compared to 50% for both the anterior and posterior circulation cohorts. For the safety 
endpoint of major ipsilateral stroke and neurological death, the upper bound of the confidence interval 
will be compared to 20% for the anterior circulation cohort, and 25% for the posterior circulation cohort. 
Success requires safety and effectiveness endpoints to be met in each cohort separately. Success in the 
anterior cohort occurs when the lower bound of the effectiveness endpoint is above 50% and the upper 
bound of the safety endpoint is below 20%. Success in the posterior cohort occurs when the lower bound 
of the effectiveness endpoint is above 50% and the upper bound of the safety endpoint is below 25%. 
The analysis of long-term safety and effectiveness data will be descriptive only, as no formal hypotheses 
will be tested based on data collected during this phase of the study. Survival analysis will be used to 
estimate the incidence of specified safety endpoint events, as well as retreatment of the target aneurysm. 
Details regarding the survival analyses are summarized in Table 7. 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 45 of 74 
Table 7 – Endpoint Measure Definitions in the Post-approval Study 
  
  
Survival Analysis 
Incidence Rate 
% Subjects who Experienced the 
Outcome [2] 
Competing 
Risk [1] 
Event 
Numerator 
Denominator 
Numerator 
Denominator 
Primary Safety Outcome 
Non-neurologic 
death 
The first 
event 
Number of 
events (N1) 
Person-time 
based on 
follow-up 
date (D1) 
Number of 
subjects who 
experienced new 
outcome in the 
interval (N2) 
Number of 
subjects present 
for one or more 
visits during or 
after the interval 
or experienced 
outcomes during 
the interval (D2) 
Neurological death 
New or worsening 
major ipsilateral stroke 
Death 
Any ischemic or 
hemorrhagic AE(s) 
Hemorrhagic Stroke 
Ischemic Stroke 
SAH 
Aneurysm Rupture 
TIA 
Device-related SAE(s) 
Grade 1 Raymond class 
in the absence of 
retreatment, or parent 
artery stenosis (>50%) at 
the target location 
N/A 
N/A 
N/A 
N/A 
Number of 
subjects who are 
not retreated and 
whose current 
DSA met the 
outcome 
definition 
Number of 
subjects with 
valid DSA or 
underwent 
retreatment 
Retreatment 
Death 
The first 
event 
N1 
D1 
N2 
D2 
Raymond Class 
N/A 
N/A 
N/A 
N/A 
Number of 
subjects whose 
current DSA met 
the outcome 
definition 
Number of 
subjects with 
valid DSA 
Parent Artery Stenosis 
> 50% 
N/A 
N/A 
N/A 
N/A 
Recanalization 
Death 
The first 
event 
N1 
Person-time 
based on 
DSA date 
Stent Migration 
Progressive Occlusion of 
the Target Aneurysm 
N/A 
N/A 
N/A 
N/A 
[1] Subjects are censored on the date of the event; other censoring events include lost-to-follow-up, consent withdrawal, and study 
early discontinuations due to other reasons. 
[2] Repeated for each visit interval, i.e. 2-year, 3-year, post-3-year intervals. 
[3] The observational period for the survival analysis and incidence rate starts on the day after a subject's 12-month follow-up visit. 
 
4.6.1 
Baseline Variables 
Baseline variables will be collected including but not limited to: gender, race, age, BMI, hypertension, 
heart disease, diabetes, smoking status, previous stroke history, baseline rupture/un-rupture status, 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 46 of 74 
aneurysm size, dome size, neck size, dome to neck ratio, aneurysm location, use of antiplatelet agents, 
and other factors. For baseline ruptured aneurysms, the days/time from the most recent rupture to the 
index procedure will be summarized and reported. For unruptured aneurysms measuring <7mm for each 
of three dimensions assessed (height, width, and depth), a baseline variable of “reason for treatment” will 
also be collected. 
The baseline variables will be summarized using descriptive statistics. Continuous variables such as age 
and BMI will be summarized using mean, standard deviation and N. Categorical variables such as 
hypertension and diabetes will be summarized using a percentage of subjects exhibiting the characteristic 
along with the numerator and denominator of that percentage. 
4.6.2 
Post-procedure Variables 
Stryker Neurovascular will analyze the success rate of the Neuroform Atlas™ Stent post-procedure with 
95% CI. Stryker Neurovascular will also report any device malfunctions, and all available post procedure 
clinical outcomes as well as the immediate post procedure image score (Raymond score by Core Lab 
reading).  
4.6.3 
Long Term Follow-up Variables 
Long-term safety data will be collected from 12 months through 3 years (± 6 months) post-index 
procedure within the following categories: 
• 
Neurological death or major ipsilateral stroke 
• 
Any ischemic or hemorrhagic event of any severity or duration (including TIAs, SAH, and 
aneurysm rupture)  
• 
Device-related SAEs 
 
In addition, neurological assessments will be conducted in person at each follow-up visit, and all new and 
ongoing adverse events will be recorded and adjudicated as specified by the CEC charter. 
 
For imaging performed per standard of care, the long-term effectiveness endpoints identified below will 
be assessed from 12 months through 3 years (± 6 months) post-index procedure per the long-term follow-
up schedule requirements: 
• 
Retreatment 
• 
Parent artery stenosis at the target aneurysm location (>50% stenosis) 
• 
Composite effectiveness measure (complete aneurysm occlusion [Raymond 1]  without 
significant parent artery stenosis at the target aneurysm location [>50% stenosis] or 
retreatment) 
• 
Recanalization 
• 
Stent migration based on follow-up angiogram 
• 
Aneurysm occlusion of Raymond Class 1, 2, or 3 
• 
Aneurysm occlusion of Raymond Class 1 and 2 combined 
• 
Progressive occlusion of the target aneurysm 
4.6.4 
Pooling across Institutions 
Subgroup analysis will be done to assess if there is heterogeneity among the sites, and to determine if 
pooling of the data is reasonable. The percentage of patients with total occlusion within each site will be 
determined and a Pearson chi-square statistic will be used to determine if there are differences between 
sites. If the p-value of the Pearson chi-square statistic is greater than 0.10 then the sites will be 
considered poolable. If there are one or two outlier sites, a sensitivity analysis will be done by including 
them in the analysis as well as excluding those sites in the repeat comparable analysis. 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 47 of 74 
4.6.5 
Additional Comparisons 
There is no plan for any additional comparisons at this time. 
4.6.6 
Other Analysis Methods 
Stryker Neurovascular may carry out additional analyses for exploratory purposes, such as using the 
following variables as the stratified variable for additional subgroup analysis: gender, race and other 
baseline characteristics. 
4.6.7 
Covariates 
Baseline variables are mentioned in Section 4.6.1 above. Additional procedural variables will be the 
length of the procedure, the number of coils successfully implanted, packing density, etc. Post procedure 
variables have been described in Section 4.6.2. 
These additional covariates will be summarized using descriptive statistics as described for the baseline 
variables. 
4.7 
Subject Accountability 
All subjects will be included in a summary of subject accountability for this study. The frequency and 
percentages of subjects enrolled, present at each visit, discontinuing before study completion (including 
reason for discontinuation) and completing the study will be presented in the final report. For subjects 
lost to follow-up, the date of last contact will be used to define the censor date. 
4.8 
Follow-up and Reporting 
All subjects enrolled and devices used in the clinical investigation will be accounted for in the final 
report. All reasons for exclusion from analysis will be documented. Similarly, for all subjects and 
devices included in an analysis population, the measurements of all important variables will be accounted 
for at all relevant time points.  
Subjects lost to follow-up or withdrawn from the study will be identified, and a descriptive analysis of 
them will be provided, including the reasons for their loss to follow-up and known treatment outcomes.  
 All PAS mITT subjects will be asked to return for a 2-year visit and a 3-year visit. If the 3-year visit 
window has elapsed at the initiation of the PAS follow-up, subjects will be asked to return for at least 
one long-term follow-up visit. 
The analysis of long-term safety and effectiveness data will be descriptive only, as no formal hypotheses 
will be tested based on data collected during this phase of the study. Survival analysis will be used to 
estimate the incidence of specified safety endpoint events, as well as retreatment of the target aneurysm. 
4.9 
Assessment of Attrition Bias 
Differential attrition rates among subgroups of the ATLAS subjects could potentially bias the observed 
safety and durability status in both directions. Adverse events may prevent patients from adequately 
participating in the study, i.e., informative censorings are created. On the other hand, certain tests may be 
biased due to the under-participation of the healthier subgroup. Adverse events may result in more 
frequent hospital visits and therefore a better chance to report mRS and NIHSS. Difficult-to-treat 
aneurysms with suboptimal occlusion status may be more likely to undergo additional angiograms and to 
be evaluated with the Raymond-Roy scale. 
Analyses will be performed at various stages of the PAS to evaluate the potential effects of attrition bias. 
Since subjects who died, withdrew, or are lost to follow-up can no longer be followed in the PAS, 
statistics reported for the PAS mITT cohort should be interpreted as conditional on a given subject’s 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 48 of 74 
survival of the first 12 months after the procedure. At the initiation of the PAS, summary statistics on 
demographics and key clinical characteristics at 12-month follow-up visits will be compared between 
cohorts with and without deaths, withdrawals, and loss to follow-up. Once patient enrollment for the 
PAS begins, we will update the PAS mITT cohort with the actual enrollment and present the updated 
comparison in the interim progress reports and final report.. Sensitivity analyses will be carried out based 
on different assumptions of the pattern of loss to follow-up. Raymond-Roy scale and mRS will be 
reported within the context of previous test results. All analyses performed on the PAS mITT cohort will 
be compared to the PAS ITT population. 
5 
Data Management 
5.1 
Data Collection and Processing 
Subject data will be collected in a secure electronic data capture (EDC) system via the Internet. The 
Principal Investigator or Sub-investigator must ensure the accuracy and completeness of the recorded 
data and then provide his/her electronic signature on the appropriate electronic Case Report Forms 
(eCRFs). Changes to data previously submitted to the Sponsor will require a new electronic signature by 
the investigator to acknowledge/approve the changes. 
Visual and/or computer data review will be performed to identify possible data discrepancies. Manual 
and/or automatic queries will be created in the EDC system and will be issued to the site or angiographic 
Core Lab for appropriate response. The site staff will be responsible for resolving all queries in the 
database. 
Results from the angiographic Core Lab will also be entered or uploaded into the EDC system. Audits 
may be performed for quality assurance of data handling against Core Lab procedures. 
6 
Adverse Events 
An Adverse Event (AE) is any undesired clinical response or complication experienced by a subject. All 
AEs (within the study duration), whether device-related or not, will be recorded on the AE case report 
forms. Data to be collected will include the description of the AE event term, onset and resolution dates 
(or whether the AE is ongoing), severity, management/treatment, outcome, and determination of the 
relationship to the device and/or procedure. 
6.1 
Adverse Event Definitions and Classification 
Table 8 – Adverse Event Definitions and Classifications 
Term 
Definition 
Reference 
Adverse Event 
(AE) 
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device. 
NOTE 1: This definition includes events related to the investigational 
medical device or procedures involved. 
ISO 14155 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 49 of 74 
Term 
Definition 
Reference 
Adverse Device 
Effect (ADE)  
Adverse event related to the use of an investigational 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 
investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or 
from intentional misuse of the investigational device. 
ISO 14155 
Serious Adverse 
Event (SAE) 
Adverse event that: 
A. led to death, 
B. led to serious deterioration in the health of the subject, that 
resulted in either: 
1. a life-threatening illness or injury, 
2. a permanent impairment of a body structure or a body 
function, 
3. in-subject or prolonged hospitalization, 
4. medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body 
structure or a body function, 
C. 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 clinical investigational plan, without serious 
deterioration in health, is not considered a SAE. 
ISO 14155 
Serious Adverse 
Device Effect 
(SADE) 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
ISO 14155 
Unanticipated 
Adverse Device 
Effect (UADE)  
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 investigational plan 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. 
21 CFR Part 812 
Underlying diseases are not reported as Adverse Events (AEs) unless there is an increase in severity or 
frequency during the course of the investigation. Death should not be recorded as an adverse event, but 
should only be reflected as an outcome to another specific SAE. Any AE experienced by the study 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 50 of 74 
subject after informed consent whether during or subsequent to the procedure must be recorded in the 
(e)CRF. 
All AEs and SAEs will be monitored and collected from the time of enrollment through 3 years (± 6 
months) post-index procedure. 
Relationship to the Device: 
The Investigator must assess the relationship of the adverse event to the study device using the following 
criteria categories and definitions: 
o 
Unrelated - The adverse event is determined to be due to a concurrent illness or effect of another 
device/drug and is not related to the investigational product. 
o 
Possible - The adverse event is determined to be potentially related to the investigational product, 
and an alternative etiology is equally or less likely compared to the potential relationship to the 
investigational product. 
o 
Probable - There is a strong relationship to the investigational product, or recurs on re-challenge, 
and another etiology is unlikely. 
o 
Related - There is no other reasonable medical explanation for the event. 
Relationship to the Procedure: 
The Investigator must assess the relationship of the adverse event to the index procedure using the 
following categories and definitions: 
o 
Unrelated - The adverse event is determined to be due to a concurrent illness or effect of a 
device/drug and is not related to the index procedure. 
o 
Possible - The adverse event is determined to be potentially related to the index procedure, and an 
alternative etiology is equally or less likely compared to the potential relationship to the index 
procedure. 
o 
Probable - There is a strong relationship to the index procedure, or recurs on re-challenge, and 
another etiology is unlikely. 
o 
Related - There is no other reasonable medical explanation for the event. 
6.2 
Reporting Requirements 
The Sponsor will ensure that event reporting is as mandated by the FDA and/or local Regulatory 
Authorities. The communication requirements for Adverse Event reporting to the Sponsor are as follows: 
Table 9 – Communication Requirements for Reporting Adverse Events to the Sponsor 
Adverse Event 
Classification 
Communication Method 
Communication 
Timeline 
Primary Sponsor 
Contact 
UADE 
Complete AE (e)CRF 
page including UADE 
question with all available 
new and updated 
information 
Within 24 hours of first 
becoming aware of the 
event. 
Clinical Research 
Associate and/or Clinical 
Affairs Safety 
Representative 

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Adverse Event 
Classification 
Communication Method 
Communication 
Timeline 
Primary Sponsor 
Contact 
SAE and/or SADE (EU 
only) 
Complete AE (e)CRF 
page with all available 
new and updated 
information 
Within 24 hours of first 
becoming aware of the 
event. 
Clinical Affairs Safety 
Representative 
AE 
Complete AE (e)CRF 
page 
As soon as possible 
Clinical Research 
Associate 
Device Failures, 
Malfunctions, and 
Product 
Nonconformities 
Complete CRF pages 
with all available new and 
updated information 
Within 24 hours of first 
becoming aware of the 
event 
Clinical Research 
Associate, Clinical 
Affairs Safety 
Representative 
6.3 
Device Failures, Malfunctions, and Product Nonconformities 
All device failures, malfunctions, and product nonconformities will be documented on the appropriate 
eCRF and the device should be returned to the Sponsor for analysis. Instructions for returning the 
investigational device will be provided in the study Manual of Operations. Device failures and 
malfunctions should also be documented in the subject’s medical record. 
Note: Device failures, malfunctions, and product nonconformities 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. 
6.4 
Reporting to Regulatory Authorities/IRBs / ECs /Investigators 
The Sponsor is responsible for reporting adverse event information to all participating investigators and 
regulatory authorities, as applicable. 
The Site Principal Investigator is responsible for informing the IRB/EC of UADEs, SAEs, and/or events 
as required by local procedure. A copy of this report should be sent to the Sponsor Clinical Research 
Associate. 
Refer to Section 10.2 for information pertaining to the Clinical Events Committee (CEC). 
7 
Risk Analysis 
7.1 
Known and Anticipated Risks 
Subjects treated in this study will be exposed to risks associated with intravascular catheterization, stent 
placement, neurovascular embolization coil placement, and general anesthesia. These risks include but 
are not limited to: 
1. Allergic reaction to Nitinol metal and medications 
2. Aneurysm perforation/rupture 
3. Coil herniation through stent into parent vessel 

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4. Death 
5. Embolus 
6. Hemorrhage 
7. In-stent stenosis 
8. Infection 
9. Ischemia 
10. Neurological deficit/intracranial sequelae 
11. Pseudoaneurysm 
12. Recanalization requiring retreatment 
13. Stent fracture 
14. Stent migration/embolization 
15. Stent misplacement 
16. Stent thrombosis 
17. Stroke 
18. Transient ischemic attack 
19. Vasospasm 
20. Vessel occlusion or closure 
21. Vessel perforation/rupture, dissection, trauma or damage 
22. Vessel thrombosis 
23. Other procedural complications including but not limited to anesthetic and contrast media risks, 
hypotension, hypertension, access site complications.  
Refer to the appropriate embolic coil DFU for other complications that may occur due to coil 
embolization. 
Subjects treated with Aspirin and Clopidogrel will be exposed to certain risks. These risks include but are 
not limited to: 
1. Bleeding, including access site, cerebral and gastrointestinal bleeding 
2. Abdominal pain, nausea, vomiting, dyspepsia 
3. Gastric ulcer, gastritis 
4. Rash 
5. Retroperitoneal hematoma 
6. Anemia 
7.2 
Reported Benefits 
Endovascular aneurysm treatment with the Neuroform Atlas™ Stent System may offer certain 
advantages as compared to no treatment or alternative treatment of an intracranial aneurysm. Potential 
benefits that may be associated with use of Neuroform Atlas™ Stent System for the intended subject 
population include: 
• 
Reduced occurrence of rupture 
• 
Reduced occurrence of recanalization 

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• 
Ability to treat wide neck aneurysms; these aneurysms are considered at the highest risk of rupture 
and some aneurysms are not treatable with current standard of care techniques (coiling, balloon 
supported coiling and surgery) 
• 
Increased navigability and the treatment of more challenging aneurysms due to thinner, lower 
profile and higher flexibility of the stent 
• 
Acceptable safety profile compared to existing technologies for treatment of wide neck 
aneurysms[71] 
A history of successful commercialization of the previous generations of the Neuroform Atlas™ Stent 
System confirmed that clinical benefits associated with the use of these products outweigh clinical risks. 
7.3 
Risk Minimization 
Subjects will be carefully evaluated before entering the study to ensure that the location, diameter, and 
length of the aneurysm are appropriate for treatment with the Neuroform Atlas™ Stent and embolic 
coiling. 
Only trained surgeons with expertise in the endovascular treatment of intracranial aneurysms will 
participate in this study. Prior to enrolling and treating a subject in the study, all Investigators will review 
and understand the DFU, and will be trained by the Sponsor with regards to use of the Neuroform 
Atlas™ Stent System. 
Subjects will be heparinized during the endovascular procedure to reduce the risk of thrombosis. 
Antibiotics will be administered in subjects with increased risk of post-operative infection. 
Subjects will be carefully monitored during the study and the follow-up period. The Site Principal 
Investigator (or designee) will examine and perform various diagnostic tests immediately after the 
procedure, at hospital discharge, at the 2, 6 and 12-month follow up, and at the 2- and 3-year follow-up 
visits. 
In addition to monitoring data directly related to the Neuroform Atlas™ Stent and embolization coil 
placement, blood data will be obtained preoperatively and postoperatively. These data will be used to 
determine the subject’s coagulation status, to assess for infection as indicated by white blood cell count, 
and to detect significant internal bleeding with hemoglobin and hematocrit levels. 
Data from all clinical sites will be monitored as it is submitted to the Sponsor, or the Sponsor’s 
representatives will conduct monitoring visits at each investigational site before the study begins and at 
least every six months during the study to determine if the protocol is being followed. The Sponsor will 
routinely review the data and any other issues that may affect the safety and welfare of the subjects. 
Based on the risks identified and the procedural and monitoring methods employed to minimize these 
risks, the Sponsor believes that the potential benefits of treatment with the Neuroform Atlas™ Stent 
System outweigh the associated risks of the procedure. 
7.4 
Risk Benefit Analysis 
7.4.1 
Subject Population 
Potential risks to study subjects have been minimized by establishing strict inclusion/exclusion criteria to 
assure only appropriate candidates participate in the study. Only those subjects presenting with a wide 
neck (neck ≥4mm or a dome-to-neck ratio <2), intracranial, saccular aneurysm arising from a parent 
vessel with a diameter of ≥2mm and ≤4.5 mm, who are deemed eligible to participate in the study, will 
receive stent-assisted coiling with the Neuroform Atlas™ Stent System. Selection of embolic coils will 
be restricted to commercially available bare metal coils only. 

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7.4.2 
Justification for Investigation 
Although there are risks associated with use of the Neuroform Atlas™ Stent System, these risks are the 
same as those associated with the use of prior generations of the Neuroform Stent (Neuroform EZ and 
Neuroform EZ3), all of which have received Humanitarian Device Exemption (HDE) approval from the 
FDA. HDE approval is based upon, among other criteria, a determination by the FDA that the 
humanitarian use device will not expose subjects to an unreasonable or significant risk of illness or 
injury, and the probable benefit to health from use of the device outweighs the risk of injury or illness 
from its use, while taking into account the probable risks and benefits of currently available devices or 
alternative forms of treatment.[3] 
From a procedural standpoint, prior generation devices have shown a satisfactory history of clinical use. 
Appropriate steps have been taken to minimize the risks associated with the device design and materials. 
In addition, protocol-specified procedural and monitoring methods (as specified in Section 7.3 above) 
will be employed to minimize risks to study subjects.  
There are substantial potential benefits associated with treatment using the Neuroform Atlas™ Stent 
System, and the risks associated with the procedure have been identified and minimized where possible. 
Thus, the balance of potential risks and benefits associated with use of the Neuroform Atlas™ Stent 
System warrants further clinical research and justifies this investigation. 
8 
Device Description 
8.1 
Detailed Device Description 
The proposed Neuroform Atlas™ Stent System is similar to the Neuroform EZ Stent System and consists 
of the following three components: 
• 
Self-expanding Stent 
• 
Stent Delivery Wire 
• 
The stent delivery wire comes in two configurations: 1. With an 8.5 mm distal tip. 2. Without 
a distal tip. Select a configuration based upon physician preference 
• 
An accessory pouch containing an optional torque device. The physician my attach the torque 
device to the proximal end of the stent delivery wire to facilitate handling and stabilization 
The system provides a laser cut, nitinol, self-expanding stent preloaded over a delivery wire inside an 
introducer sheath.  The sheath and delivery wire are used to transfer the stent into a 0.0165”- 0.0170” ID 
microcatheter.  After transfer, the sheath is removed from the system via the proximal end of the delivery 
wire.  The delivery wire is then used to advance the stent to the distal end of the catheter.  The catheter, 
stent, and delivery wire are repositioned appropriately to ensure the stent is located across the neck of the 
aneurysm.  The stent is deployed by stabilizing the delivery wire and withdrawing the catheter.   
The operating principles, materials and device features of the Neuroform Atlas™ Stent System are 
similar to those of the Neuroform EZ Stent System with the exception of microcatheter size 
compatibility. To improve stent delivery and ease of use, and to reduce procedure time, the Neuroform 
Atlas™ Stent System has been scaled down to fit inside a 0.0165” - 0.0170” ID microcatheter.  The 
Neuroform EZ Stent is compatible with a 0.027” ID microcatheter. 
Self-expanding Stent: 
Both the Neuroform EZ Stent and Neuroform Atlas™ Stent share a self-expanding, open-cell, nitinol 
design with radiopaque marker bands on each end (proximal and distal). Zig-zag shaped elements make 
up the pattern of both designs.  The zig-zag elements are connected by interconnects (3/2 mix for 
Neuroform EZ and 4 connectors symmetrically patterned for the Neuroform Atlas™ Stent).  Both stents 
are laser cut from a Nitinol tube. The Neuroform EZ and Neuroform Atlas™ Stents include 4 and 3 
markers per end, respectively.   

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Although the Neuroform EZ Stent and Neuroform Atlas™ Stent cut patterns are different, the devices’ 
ability to support embolization coils in the aneurysm and their clinical performance are expected to be 
similar. Table 10 is a summary of the Neuroform EZ Stent and Neuroform Atlas Stent features.  
 
Table 10 – Neuroform EZ Stent and Neuroform Atlas™ Stent Summary 
Delivery System: 
Stent Delivery Wire 
The function and operating principles of the Neuroform Atlas™ Stent Delivery Wire are the same as 
those for the Neuroform EZ Stent Delivery Wire. The stent delivery wire is a component similar in 
construction to a guidewire, and is composed of 304V stainless steel. The stent delivery wire is designed 
to be used with 150cm microcatheters.  The stent comes preloaded on the stent delivery wire inside the 
introducer sheath and is used to advance the stent into the microcatheter. 
Introducer Sheath 
The introducer sheath for the Neuroform Atlas™ Stent System and the Neuroform EZ Stent System is a 
polymer-based material which covers both the stent and the stent delivery wire. The purpose of the 
introducer sheath is to constrain the stent prior to use and to assist in transferring the stent into the 
microcatheter. The introducer sheath is also used to protect the stent during sterilization, storage, 
shipping, and handling. 
Microcatheter 
 
Neuroform EZ Stent 
Neuroform Atlas™ Stent 
Stent Design  
 
 
Material 
Nitinol, ASTM F2063-12 
Nitinol, ASTM F2063-12 
Design 
Open cell 
Open cell 
Deployment 
Self-Expanding 
Self-Expanding 
Vessel Diameter 
2.0-4.5 mm 
2.0-4.5 mm 
Expanded Diameters (mm) 
3.0, 3.5, 4.0, 4.5, 5.0 
3.5, 4.5, 5.0 
Lengths (mm) 
10, 15, 20, 30 
15, 21, 24, 30 
Cells & Interconnects 
8 cells, 2-3 interconnects  
8/12 cells, 4 interconnects  
End ring Design  
Unflared 
Flared  
Radiopaque Markers  
4 per end, crimped sleeve, Pt/Ir alloy 
3 per end, crimped sleeve, Pt/Ir alloy 

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Please note:  Similar to the 0.027” ID microcatheter that is used in conjunction with the Neuroform EZ 
Stent System, the 0.0165” - 0.0170” ID microcatheters used in conjunction with the Neuroform Atlas™ 
Stent System are sold separately and will not be part of the Neuroform Atlas™ Stent System. 
8.2 
Procedural Technique 
The Neuroform Atlas™ Stent System will be used as an adjunct to coil embolization in accordance with 
the instructions provided in Section 3.8.2 Implant/Procedural Steps, and the Directions for Use (DFU) 
included in each device package 
8.3 
Device Labeling 
A copy of the Directions for Use (DFU) will be included in each device package which includes a 
description of all relevant contraindications, hazards, adverse effects, interfering substances or devices, 
warnings, and precautions. 
The study devices will be labeled on the Package Carton and Sterile Barrier (pouch). The labels will 
contain the following information:  
• 
Name and place of business of the manufacturer, packer, or distributor  
• 
Quantity of contents 
• 
"CAUTION--Investigational device. Limited by Federal (or United States) law to 
investigational use."  
• 
Device Dimensions 
• 
Lot Number 
• 
Expiration Date 
9 
Monitoring Plan 
Monitoring for this study will be conducted by the Sponsor or designee in accordance with the study 
monitoring plan. The study will be monitored to ensure that the protocol, applicable regulations, and 
Good Clinical Practice (GCP) Guidelines are followed. The Monitor will ensure that the rights and well-
being of subjects are protected in compliance with Title 21 of the Code of Federal Regulations (21 CFR), 
parts 50, 56 and 812, and Title 45 (45 CFR), part 46, and that the clinical trial data are accurate, 
complete, and verifiable. 
9.1 
Monitoring Procedures 
9.1.1 
Qualification and Initiation 
All sites will undergo a qualification process to confirm acceptability for participation into the study. 
Study initiation training visits or webcasts will be performed at the start of the clinical study to ensure 
that the study personnel have a complete understanding of the protocol, procedures, responsibilities, and 
regulations involved with the conduct of a clinical trial. Study personnel will be trained on all essential 
aspects of the trial prior to the first subject being enrolled in the study. This training will include an in-
depth review of the protocol and case report forms, regulatory requirements, serious adverse experience 
reporting, and other activities as documented in the monitoring plan. 
9.1.2 
Periodic Monitoring 
Periodic monitoring activities will be conducted at all active investigational sites throughout the clinical 
study in order to assure that the Investigator obligations are fulfilled and all applicable regulations and 
guidelines are being followed. During monitoring activities (on-site or remote), the monitor will verify 
the following data: 

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o 
Verification that informed consent was obtained appropriately 
o 
Adherence to protocol eligibility criteria  
o 
Procedures for documenting appropriate accountability and administration of the investigational 
product  
o 
Conduct and documentation of procedures and assessments related to: 
▪ 
study endpoints 
▪ 
protocol-required safety assessments 
▪ 
evaluating, documenting, and reporting serious adverse events and unanticipated adverse device 
effects, subject deaths, and withdrawals, especially when a withdrawal may be related to an 
adverse event 
▪ 
conduct and documentation of procedures essential to trial integrity 
9.1.3 
Documentation 
Documentation of monitoring activities will include the following to provide sufficient detail to verify 
that the monitoring plan was followed: 
o 
The date of the activity and the individual(s) conducting and participating in it 
o 
A summary of the data or activities reviewed 
o 
A description of any noncompliance, potential noncompliance, data irregularities, or other 
deficiencies identified 
o 
A description of any actions taken, to be taken, or recommended, including the person responsible 
for completing actions and the anticipated date of completion  
9.2 
Name and Address of Monitor 
The Sponsor of the study, SNV, or designated Contract Research Organization (CRO), is responsible for 
the monitoring of the study. The Sponsor will ensure that the study is monitored by personnel qualified 
by training and experience to monitor the progress of the investigation.  
The Clinical Affairs department has overall responsibility for monitoring this study and is located at: 
 
Stryker Neurovascular 
47900 Bayside Parkway 
Fremont, CA 94538-6515 
Tel. 510 413-2500 
 
NOTE:  A complete list of study monitors and their qualifications will be maintained and will be 
available upon request. 
9.3 
Auditing 
The study may be subject to a quality assurance audit by the Sponsor or its designees, as well as 
inspection by appropriate regulatory authorities. 
It is important that the Investigator and relevant study personnel are available during any audits, and that 
sufficient time is devoted to the process. 

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9.4 
Device Accountability 
Device accountability records must be maintained at the study site. The quantity of devices received by 
the study site, those returned to the supplier, and those devices used at the study site will be recorded in 
the device accountability record. The Site Investigator must explain in writing the reasons for any 
discrepancy noted in device accountability. 
10 
Study Committees 
10.1 
Steering Committee 
A Steering Committee will be responsible for overall oversight of the science and execution of the study. 
It will provide key input regarding study planning, execution, and presentation. 
10.2 
Clinical Events Committee/Data Safety Monitoring Board (CEC/DSMB) 
The Clinical Events Committee/Data and Safety Monitoring Board (CEC/DSMB) is an independent 
group of experts that advises the study sponsor, Stryker, and the study investigators. The members of the 
CEC/DSMB serve in an individual capacity and provide their expertise and recommendations. The 
primary responsibilities of the CEC/DSMB are to:  
1) periodically review and evaluate the accumulated study data for participant safety, study conduct and 
progress; 
2) adjudicate pre-specified clinical events as they occur through the 12 month primary endpoint of the 
IDE study, and through the end of the PAS study;  
3) make recommendations to the study sponsor concerning the continuation, modification, or termination 
of the trial. The CEC/DSMB considers study-specific data as well as relevant background knowledge 
about the disease, or patient population under study. 
The CEC/DSMB shall be composed of at least three members (physicians from the fields of stroke 
neurology, interventional neurology, neuroradiology or vascular neurosurgery).  In order to minimize any 
potential bias, the members of the CEC/DSMB will be independent and will not be directly involved 
with the conduct of the study or have any financial conflict. 
The CEC/DSMB will review the study on a regular basis as described in the charter established prior to 
the commencement of the trial. A mission statement and procedures for the committee will be formalized 
in the charter. The CEC/DSMB will be responsible for reviewing aggregate safety data in order to ensure 
overall safety of study subjects during the execution of the trial. Guidelines for stopping rules for pre-
specified safety endpoints will be established in the charter. 
The Committee will be responsible for monitoring patient safety for the duration of patient enrollment 
and through the end of the PAS study follow up for all subjects. The study endpoints will be reviewed, 
and safety event causality will be adjudicated as related to the study device, procedure, both, other 
(specify). Data adjudicated by the independent CEC/DSMB will be used for final analysis. 
11 
Ethical and Regulatory Considerations 
11.1 
Compliance with Good Clinical Practices (GCP) 
As the Sponsor of this clinical study, SNV has overall responsibility for the conduct of the study, 
including assurance that the study meets US federal and local regulatory requirements appropriate to the 
conduct of the study. In this study, the Sponsor will have certain direct responsibilities, and will delegate 
other responsibilities to a Contract Research Organization (CRO). The Sponsor will adhere to Sponsor 

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general duties as described in ISO 14155:2011, Clinical investigation of medical devices for human 
subjects – Good clinical practice, and CFR Part 812, 50, 56, 54 and the World Medical Association 
Declaration of Helsinki. 
The Site Clinical Investigators 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. 
11.2 
Institutional Review Board/Independent Ethics Committee 
A copy of the protocol, proposed Informed Consent form, other written subject information, and any 
proposed advertising material must be submitted to the IRB/IEC for written approval. A copy of the 
written IRB/IEC approval of the protocol and Informed Consent form must be received by the Sponsor 
before recruitment of subjects into the study and shipment of investigational product. 
The Investigator must submit and, where necessary, obtain approval from the IRB/IEC for all subsequent 
protocol amendments and changes to the Informed Consent form. The Investigator must notify the 
IRB/IEC and Sponsor of any deviations from the protocol or any SAEs/UADEs occurring at the site and 
other SAE/UADE reports received from the Sponsor in accordance with local procedures. 
The Investigator is responsible for obtaining annual IRB/IEC approval and renewal throughout the 
duration of the study. Copies of the Investigator’s reports and the IRB/IEC continuance of approval must 
be sent to the Sponsor. 
11.3 
Written Informed Consent Form 
The Sponsor will provide a sample Informed Consent Form to the Investigator to prepare for use at 
his/her site. The written Informed Consent documents should be prepared in the language(s) of the 
potential subject population. 
The Sponsor and the reviewing IRB/IEC must first approve the Informed Consent Form(s) before use at 
that site/center. The Informed Consent form(s) must be in agreement with the current guidelines as 
outlined by the Good Clinical Practices (GCP) guidelines, Declaration of Helsinki, and the International 
Conference on Harmonization (ICH). 
Before participating in the clinical trial, each subject must give written Informed Consent after the 
context of the study has been fully explained to the subject in a language that is easily understood by the 
subject. The subject also must be given the opportunity to ask questions and have those questions 
answered to his/her satisfaction. Subjects will be informed by the Investigator or Investigator’s designee 
that they are free to refuse participation in this research study. If they elect to participate, it will be made 
clear that they may withdraw from the study at any time without prejudicing further care. 
Written Informed Consent must be recorded appropriately by means of the subject’s, or his/her legal 
representative’s dated signature. The consent process must be documented in the subject’s medical chart. 
11.4 
Amending the Protocol 
This protocol must be followed exactly, and can be altered only by written amendments. Following 
appropriate approval, the revised protocol will be distributed to all protocol recipients. 
11.5 
Emergency Actions 
The Sponsor accepts the right of the Investigator to deviate from the protocol in an emergency when 
necessary in order to safeguard the life or the physical wellbeing of a study subject. The Investigator 
must give notice of any emergency deviation, and justification for the deviation must be provided to the 
Sponsor and the IRB/IEC as quickly as possible after the episode, and in any event, no later than 24 
hours after the emergency. 

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11.6 
Protocol Adherence 
Prior to beginning the study, the Investigator must sign the Investigator Agreement and Signature page 
documenting his/her agreement 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. Each deviation from the protocol must be documented with the date 
and reason for the deviation, and must be reported to the Sponsor and to the IRB/IEC, per local 
guidelines and government regulations.  
11.7 
Protocol Deviations 
A protocol deviation is defined as an event where the clinical Investigator or site personnel did not 
conduct the study according to the Investigational Plan or the Investigator Agreement. GCP regulations 
require that Investigators maintain accurate, complete and current records, including documents showing 
the dates and reasons for each deviation from the protocol. 
Investigators must obtain prior approval from Stryker NV clinical study management before initiating 
major deviations from the investigational plan, except where necessary to protect the life or physical 
well-being of a subject in an emergency. Such approval shall be documented in writing and maintained in 
clinical study management and Investigator files. Prior approval is generally not expected in situations 
where unforeseen circumstances are beyond the Investigator’s control (e.g. subject was not available for 
scheduled follow-up office visit, blood sample lost by laboratory, etc.); however, the event is still 
considered a deviation and will be reported on the appropriate CRF. 
Deviations shall be reported to the Sponsor regardless of whether medically justifiable, pre-approved, or 
taken to protect the subject in an emergency. Subject specific deviations will be reported on the Protocol 
Deviation Form. Non-subject specific deviations (e.g. unauthorized use of an investigational device 
outside the study, unauthorized use of an investigational device by a physician who has not signed an 
Investigator agreement or not been trained in the use of the device, etc.) will be reported to the Sponsor 
in writing. Investigators will also adhere to procedures for reporting study deviations to their IRB or IEC 
in accordance with their specific IRB reporting policies and procedures. 
For reporting purposes, the Sponsor classifies study deviations as being major or minor, as follows: 
• 
Major Deviation: Any deviation from subject inclusion and exclusion criteria, subject informed 
consent procedures or unauthorized device use. 
• 
Minor Deviation: Deviation from a protocol requirement such as incomplete/inadequate subject 
testing procedures, follow-ups performed outside specified time windows, etc. 
Minor Deviations that continue to occur at an investigational site may be classified as Major Deviations 
if corrective action is not taken to secure future compliance to the protocol. 
All protocol deviations will be tabulated and summarized in the final study report. 
12 
Study Administration 
The Sponsor will make necessary efforts to ensure that this study is conducted in compliance with GCPs 
and all applicable regulatory requirements. 
12.1 
Pre-Study Documentation Requirements 
Prior to subject enrollment, the Sponsor (or designee) will obtain the essential regulatory documents 
required to initiate the study. The Sponsor will be responsible for the review and approval of the 
following essential documents:  
• 
Protocol Signature Page 

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• 
Current Protocol Revision 
• 
Investigator Agreement 
• 
Financial disclosure or certification 
• 
IRB approval letter for the protocol and consent form 
• 
IRB approved consent form 
• 
IRB membership roster or assurance number 
• 
Copies of file documents will be maintained by the Sponsor 
12.2 
Record Retention 
The Investigator will maintain all essential trial documents and source documentation, in original format, 
that support the data collected on the study subjects in compliance with the ICH/GCP guidelines. 
Documents must be retained for at least 2 years after the last approval of marketing application or until at 
least 2 years have elapsed since the formal discontinuation of the clinical investigation of the product. 
These documents will be retained for a longer period of time by agreement with the Sponsor, or in 
compliance with other regulatory requirements. When these documents no longer need to be maintained, 
it is the Sponsor’s responsibility to inform the Investigator. The Investigator will take measures to ensure 
that these essential documents are not accidentally damaged or destroyed. If for any reason the 
Investigator withdraws responsibility for maintaining these essential documents, custody must be 
transferred to an individual who will assume responsibility. The Sponsor must receive written 
notification of this custodial change.  
12.3 
Criteria for Terminating Study 
The Sponsor reserves the right to terminate the study, but intends only to exercise this right for valid 
scientific or administrative reasons and reasons related to the protection of subjects. Investigators and 
their associated IRB/IEC will be notified in writing in the event of termination. 
12.4 
Criteria for Suspending/Terminating a Study Center 
The Sponsor reserves the right to stop the enrollment of subjects at a study center at any time after the 
study initiation visit. Enrollment may be discontinued by the Sponsor for reasons including, but not 
limited to, the following: 
• 
Insufficient recruitment of subjects 
• 
Persistent non-compliance with the protocol 
• 
Persistent non-compliance with IRB/IEC or regulatory requirements  
In the event the Sponsor ceases enrollment at one or more sites, the Site Investigator(s) will remain 
responsible for the complete follow-up of all subjects already entered into the study, in accordance with 
the Investigational Plan. 
12.5 
Clinical Trial Registration 
The study will be registered with the National Institutes of Health National Library of Medicine’s 
ClinicalTrials.gov.  
12.6 
Release of Study Results 
A final report will be completed describing the results of all pre-specified outcomes, including negative 
results. The Sponsor will ensure that investigators and regulatory authorities will receive the information 

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contained in the final report, and will do so in a timely manner.  
 
At the conclusion of the trial, a multi-center abstract reporting the results will be prepared and may be 
presented at a major meeting(s). A multi-center publication may also be prepared for publication in a 
reputable scientific journal. The publication of results from any single center experience within the trial 
is not allowed until the aggregate study results have been published, unless there is written consent from 
the study sponsor. 
12.7 
Medicare Beneficiaries 
In this study, subjects up to 80 years of age are eligible for study enrollment if all other study-entry 
criteria are satisfied. Based on literature review and current medical practice, a large proportion of the 
subjects enrolled into this study are expected to be Medicare eligible. For example, in a large scale study 
of a similar subject population of 818 subjects harboring 916 aneurysms, who were treated with coil 
embolization, it was reported that 59% of the study population was over 50 years of age (and 15.5% of 
the total population was at least 70 years of age).[24] The results of this study are therefore expected to be 
generalizable to the Medicare beneficiary population on the basis of age. 

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13 
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Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
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Gruber, A., et al., Clinical and angiographic results of endosaccular coiling treatment of 
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Debrun, G.M., et al., Selection of cerebral aneurysms for treatment using Guglielmi 
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24. 
Murayama, Y., et al., Guglielmi detachable coil embolization of cerebral aneurysms: 11 
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25. 
Raymond, J., et al., Long-term angiographic recurrences after selective endovascular 
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26. 
Hetts, S.W., et al., Stent-assisted coiling versus coiling alone in unruptured intracranial 
aneurysms in the matrix and platinum science trial: safety, efficacy, and mid-term 
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27. 
Ihn, Y.K., et al., Utility of catheter-assisted Guglielmi detachable coiling in the treatment 
of wide-necked aneurysms. Acta Neurochir (Wien), 2006. 148(10): p. 1045-52; 
discussion 1052. 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
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28. 
Jin, S.C., et al., Simple coiling using single or multiple catheters without balloons or 
stents in middle cerebral artery bifurcation aneurysms. Neuroradiology, 2013. 55(3): p. 
321-6. 
29. 
Kwon, O.K., et al., Endovascular treatment of wide-necked aneurysms by using two 
microcatheters: techniques and outcomes in 25 patients. AJNR Am J Neuroradiol, 2005. 
26(4): p. 894-900. 
30. 
Lozier, A.P., et al., Guglielmi detachable coil embolization of posterior circulation 
aneurysms: a systematic review of the literature. Stroke, 2002. 33(10): p. 2509-18. 
31. 
Niimi, Y., et al., Endosaccular treatment of intracranial aneurysms using matrix coils: 
early experience and midterm follow-up. Stroke, 2006. 37(4): p. 1028-32. 
32. 
Johnston, S.C., et al., Predictors of rehemorrhage after treatment of ruptured 
intracranial aneurysms: the Cerebral Aneurysm Rerupture After Treatment (CARAT) 
study. Stroke, 2008. 39(1): p. 120-5. 
33. 
Grunwald, I.Q., et al., Recanalization after endovascular treatment of intracerebral 
aneurysms. Neuroradiology, 2007. 49(1): p. 41-7. 
34. 
Malek, A.M., et al., Treatment of an intracranial aneurysm using a new three-
dimensional-shape Guglielmi detachable coil: technical case report. Neurosurgery, 1999. 
44(5): p. 1142-4; discussion 1144-5. 
35. 
Yang, X., et al., Re-evaluation of cellulose acetate polymer: angiographic findings and 
histological studies. Surg Neurol, 2001. 55(2): p. 116-22. 
36. 
Levy, D.I. and A. Ku, Balloon-assisted coil placement in wide-necked aneurysms. 
Technical note. J Neurosurg, 1997. 86(4): p. 724-7. 
37. 
Aletich, V.A., et al., The remodeling technique of balloon-assisted Guglielmi detachable 
coil placement in wide-necked aneurysms: experience at the University of Illinois at 
Chicago. J Neurosurg, 2000. 93(3): p. 388-96. 
38. 
Chalouhi, N., et al., Stent-assisted coiling versus balloon remodeling of wide-neck 
aneurysms: comparison of angiographic outcomes. AJNR Am J Neuroradiol, 2013. 
34(10): p. 1987-92. 
39. 
Cottier, J.P., et al., Utility of Balloon-assisted Guglielmi Detachable Coiling in the 
Treatment of 49 Cerebral Aneurysms: A Retrospective, Multicenter Study. AJNR Am J 
Neuroradiol, 2001. 22: p. 345-351. 
40. 
Modi, J., et al., Balloon-assisted rapid intermittent sequential coiling (BRISC) technique 
for the treatment of complex wide-necked intracranial aneurysms. Interv Neuroradiol, 
2011. 17(1): p. 64-9. 
41. 
Nelson, P.K. and D.I. Levy, Balloon-assisted coil embolization of wide-necked 
aneurysms of the internal carotid artery: medium-term angiographic and clinical follow-
up in 22 patients. AJNR Am J Neuroradiol, 2001. 22(1): p. 19-26. 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
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CDM10000880, VerAF 
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42. 
Peterson, E., et al., Are aneurysms treated with balloon-assisted coiling and stent-assisted 
coiling different? Morphological analysis of 113 unruptured wide-necked aneurysms 
treated with adjunctive devices. Neurosurgery, 2014. 75(2): p. 145-51; quiz 151. 
43. 
Chalouhi, N., et al., Is packing density important in stent-assisted coiling? Neurosurgery, 
2012. 71(2): p. 381-6; discussion 386-7. 
44. 
Kulcsar, Z., et al., Neuroform stent-assisted treatment of intracranial aneurysms: long-
term follow-up study of aneurysm recurrence and in-stent stenosis rates. Neuroradiology, 
2013. 55(4): p. 459-65. 
45. 
Chalouhi, N., et al., Stent-assisted coiling of intracranial aneurysms: predictors of 
complications, recanalization, and outcome in 508 cases. Stroke, 2013. 44(5): p. 1348-
53. 
46. 
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aneurysms: a single-center experience. AJNR Am J Neuroradiol, 2005. 26(5): p. 1223-
31. 
47. 
Wanke, I., et al., Treatment of wide-necked intracranial aneurysms with a self-expanding 
stent: mid-term results. Zentralbl Neurochir, 2005. 66(4): p. 163-9. 
48. 
Katsaridis, V., C. Papagiannaki, and C. Violaris, Embolization of acutely ruptured and 
unruptured wide-necked cerebral aneurysms using the neuroform2 stent without 
pretreatment with antiplatelets: a single center experience. AJNR Am J Neuroradiol, 
2006. 27(5): p. 1123-8. 
49. 
Nelson, P.K., et al., Recent steps toward a reconstructive endovascular solution for the 
orphaned, complex-neck aneurysm. Neurosurgery, 2006. 59(5 Suppl 3): p. S77-92; 
discussion S3-13. 
50. 
Kim, Y.J., Early experiences of neuroform stent-assisted coiling in ruptured intracranial 
aneurysms. Interv Neuroradiol, 2007. 13(1): p. 31-44. 
51. 
Biondi, A., et al., Neuroform stent-assisted coil embolization of wide-neck intracranial 
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61(3): p. 460-8; discussion 468-9. 
52. 
Lee, D.H., et al., Intimal Thickening after Placement of a Neuroform Stent. Its Incidence 
and Relation to Angiographic Follow-up Results of Aneurysm Embolization. Interv 
Neuroradiol, 2007. 13(3): p. 239-46. 
53. 
Yang, X., et al., Endovascular treatment of giant and large intracranial aneurysms using 
the neuroform stent-assisted coil placement. Neurol Res, 2008. 30(6): p. 598-602. 
54. 
Kim, S.R., et al., Anatomic results and complications of stent-assisted coil embolization 
of intracranial aneurysms. Interv Neuroradiol, 2008. 14(3): p. 267-84. 
55. 
Sedat, J., et al., Endovascular occlusion of intracranial wide-necked aneurysms with 
stenting (Neuroform) and coiling: mid-term and long-term results. Neuroradiology, 2009. 
51(6): p. 401-9. 

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Aneurysms with the Neuroform Atlas™ Stent System 
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56. 
Fiorella, D., et al., Curative cerebrovascular reconstruction with the Pipeline 
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aneurysms: a prospective, consecutive, French multicentric study. AJNR Am J 
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58. 
Santillan, A., et al., Long-term clinical and angiographic results of Neuroform stent-
assisted coil embolization in wide-necked intracranial aneurysms. Neurosurgery, 2012. 
70(5): p. 1232-7; discussion 1237. 
59. 
King, B., et al., Clinical and angiographic outcomes after stent-assisted coiling of 
cerebral aneurysms with Enterprise and Neuroform stents: a comparative analysis of the 
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60. 
Seibert, B., et al., Intracranial aneurysms: review of current treatment options and 
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61. 
Lanzino, G., et al., Efficacy and safety of flow diversion for paraclinoid aneurysms: a 
matched-pair analysis compared with standard endovascular approaches. AJNR Am J 
Neuroradiol, 2012. 33(11): p. 2158-61. 
62. 
Brinjikji, W., et al., Endovascular treatment of intracranial aneurysms with flow 
diverters: a meta-analysis. Stroke, 2013. 44(2): p. 442-7. 
63. 
McDougall, C.G., et al., Bioactive versus bare platinum coils in the treatment of 
intracranial aneurysms: the MAPS (Matrix and Platinum Science) trial. AJNR Am J 
Neuroradiol, 2014. 35(5): p. 935-42. 
64. 
Roy, D., G. Milot, and J. Raymond, Endovascular treatment of unruptured aneurysms. 
Stroke, 2001. 32(9): p. 1998-2004. 
65. 
King, J.T., Jr., J. Tsevat, and M.S. Roberts, Measuring preference-based quality of life 
using the EuroQol EQ-5D in patients with cerebral aneurysms. Neurosurgery, 2009. 
65(3): p. 565-72; discussion 572-3. 
66. 
Kotowski, M., et al., Safety and occlusion rates of surgical treatment of unruptured 
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1990 to 2011. J Neurol Neurosurg Psychiatry, 2013. 84(1): p. 42-8. 
67. 
Molyneux, A.J., et al., Cerecyte coil trial: angiographic outcomes of a prospective 
randomized trial comparing endovascular coiling of cerebral aneurysms with either 
cerecyte or bare platinum coils. Stroke, 2012. 43(10): p. 2544-50. 
68. 
Rezek, I., et al., Coil type does not affect angiographic follow-up outcomes of cerebral 
aneurysm coiling: a systematic review and meta-analysis. Am J Neuroradiol, 2013. 
34(9): p. 1769-73. 
69. 
Liu, Y.Q., et al., Single-centre comparison of procedural complications, clinical 
outcome, and angiographic follow-up between coiling and stent-assisted coiling for 

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Aneurysms with the Neuroform Atlas™ Stent System 
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posterior communicating artery aneurysms Journal of Clinical Neuroscience, 2014. 
21(2140-2144). 
70. 
Song, J.H., et al., Angiographic results of wide-necked intracranial aneurysms treated 
with coil embolization : a single center experience. J Korean Neurosurg Soc, 2015. 57(4): 
p. 250-7. 
71. 
Durst, C.R., et al., Direct comparison of Neuroform and Enterprise stents in the 
treatment of wide-necked intracranial aneurysms. Clin Radiol, 2014. 
72. 
Raymond, J. and D. Roy, Safety and efficacy of endovascular treatment of acutely 
ruptured aneurysms. Neurosurgery, 1997. 41(6): p. 1235-45; discussion 1245-6. 

 
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14 
Appendices 
A. 
Abbreviations 
AE 
Adverse Event 
AGCL 
Angiographic Core Laboratory 
CBC 
Complete Blood Count 
CEC 
Clinical Events Committee 
CFR 
Code of Federal Regulations 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CT 
Computed Tomography 
CV 
Curriculum Vitae 
CVA 
Cerebrovascular Accident 
DSA 
Digital Subtraction Angiography 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
HDE 
Humanitarian Device Exemption 
IC 
Informed Consent 
ICH 
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board  
ISO 
International Organization for Standardization 
ITT 
Intent-to-Treat 
MDR 
Medical Device Report 

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MDV 
Medical Device Vigilance Report 
MEC 
Medical Ethics Committee 
MI 
Myocardial Infarction 
MR 
Magnetic Resonance 
MRA 
Magnetic Resonance Angiography 
MRI 
Magnetic Resonance Imaging 
PP 
Per Protocol 
PT 
Prothrombin Time 
PTT 
Partial Thromboplastin Time 
SAH 
Subarachnoid Hemorrhage 
SNV 
Stryker Neurovascular 
TBD 
To Be Determined 
TIA 
Transient Ischemic Attack 
B. 
Definitions 
ADJUNCTIVE THEARPY (ADJUNCTIVE DEVICE) 
Adjunctive therapy (or an adjunctive device) is a treatment (device) that is used in addition to, or together 
with, the primary treatment. Its purpose is to assist the primary treatment. 
ANEURISMAL 
Relating to an aneurysm 
ANEURYSM MORPHOLOGY 
Referring to the shape of an aneurysm 
ANEURYSM OCCLUSION 
The degree of target aneurysm occlusion by coils and/or thrombus as measured by the modified Raymond 
Scale[64, 72] 
• 
Raymond 1: complete occlusion/obliteration--no opacification of the aneurysmal sac or neck 
• 
Raymond 2:  Residual neck/dog ear – persistence of the original defect in the arterial wall but without 
opacification of the aneurysmal sac 
• 
Raymond 3: Residual aneurysm – any opacification of the aneurysmal sac 
ANGIOGRAPHIC 
The radiographic visualization of the blood vessels after injection of a radiopaque substance 
 

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ARTERIAL DISSECTION 
A tear in an artery 
ATHEROSCLEROTIC STENOSIS 
A narrowing of an artery due to an atherosclerotic process 
CBC 
Complete blood count (to include at a minimum: red cell count, white cell count, white cell differential, 
hemoglobin, and hematocrit) 
CEREBROVASCULATURE 
Blood vessels in the brain 
COMPLICATION 
Any undesirable clinical event that results in death, injury, or invasive intervention. Complications may 
include, but are not limited to aneurysmal perforation, occlusion of parent artery or side branches, distal 
embolization, hematoma, etc. Complications may or may not be related to the product that is the subject of 
this protocol. 
ELECTRONIC CASE REPORT FORM (eCRF) 
A record of the data and other information collected on each subject in the study as defined by the clinical 
protocol 
EMBOLIZATION 
The process by which or state in which a blood vessel or organ is obstructed by the lodgment of a material 
mass (as an embolus) <pulmonary embolization><embolization of a thrombus>; also: an operation in 
which pellets or embolic coils are introduced into the circulatory system in order to induce embolization in 
specific abnormal blood vessels 
HEMATOMA 
A localized mass of extravasated blood that is relatively or completely confined within an organ or tissue, a 
space, or a potential space; the blood is usually clotted (or partly clotted), and, depending on how long it 
has been there, may manifest various degrees of organization and decolorization 
HUNT & HESS SCORE 
A neurological grading system used to classify the severity of a subarachnoid hemorrhage based on a 
subject’s clinical condition 
INTRACRANIAL ANEURYSM 
An abnormal blood-filled dilatation of a blood vessel and especially an artery resulting from disease of the 
vessel wall inside the brain 
INTERVENTION 
The act or fact or a method of interfering with the outcome or course especially of a condition or process 
(as to prevent harm or improve functioning) 
INTRACRANIAL HEMORRHAGE 
Bleeding within the skull 
INTRACRANIAL SACCULAR ANEURYSMS 
Round or lobulated focal out-pouchings of intracranial vessels that usually arise from arterial bifurcations 

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ISCHEMIA 
Deficient supply of blood to a body part (as the heart or brain) that is due to obstruction of the inflow of 
arterial blood (as by the narrowing of arteries by spasm or disease) 
ISCHEMIC STROKE 
The most common kind of stroke; caused by an interruption in the flow of blood to the brain (as from a clot 
blocking a blood vessel) 
IPSILATERAL STROKE 
An acute episode of focal or global neurological dysfunction due to brain or retinal infarction, or from an 
intracranial hemorrhage (inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhages) in 
the same hemisphere of the target aneurysm. A major ipsilateral stroke is an ipsilateral stroke which is 
associated with an increase of 4 or more points on the NIHSS at 24 hours after stroke onset. 
Note: For the purpose of consistency with the primary endpoint definition, strokes in the posterior 
circulation adjudicated as being strokes “within the treated vascular territory” will be called “ipsilateral” 
strokes. 
LEUKOCYTE 
White blood cell 
MODIFIED RAYMOND SCALE 
Anatomical results assigned to 1 of 3 categories according to the Jean Raymond Grading Scale[64, 72]: 
complete obliteration of the aneurysm including the neck (class 1 or complete occlusion), persistence of 
any portion of the original defect of the arterial wall as seen on any single projection but without 
opacification of the aneurysmal sac (class 2 or residual neck), and opacification of the aneurysmal sac 
(class 3 or residual aneurysm) 
MORBIDITY 
A diseased state, or the incidence of disease 
MORTALITY 
The number of deaths in a given time or place or the proportion of deaths to population 
MODIFIED RANKIN SCALE (mRS) 
A commonly used scale that measures disability or dependence in activities of daily living in stroke victims 
NEUROLOGICAL DEATH 
Death from any neurological source including ischemic or hemorrhagic stroke 
NEUROLOGICAL DETERIORATION 
A decline in neurological status based on changes in neurological assessment 
NIHSS SCORE 
An assessment used to objectively quantify the impairment caused by a stroke. It is composed of 11 items, 
each of which scores a specific ability between 0 and 4. 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 0. 
 

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OCCLUSION 
Blockage of a vessel 
PARENT ARTERY 
The parent artery is defined as any cerebral vessel containing a target aneurysm 
PARENT ARTERY PATENCY 
An assessment of the flow of blood through the parent artery 
PROCEDURAL TECHNICAL SUCCESS 
Defined as successful delivery and deployment of the Neuroform Atlas™ Stent at the target lesion 
PRODUCT NONCONFORMITY 
A departure of a quality characteristic from its intended level or state that occurs with a severity sufficient 
to cause an associated product or service not to meet a specification requirement 
PSEUDOANEURYSM 
An encapsulated hematoma in communication with an artery. It is often difficult to distinguish from an 
expanding hematoma at the site of arterial puncture. Usually requires surgical repair. 
RECANALIZATION 
A categorical increase in aneurysm filling over time after some degree of occlusion has been achieved 
initially.  
RETREATMENT (OF TARGET ANEURYSM) 
Required reintervention of the treated target lesion due to aneurysm recanalization or in-stent stenosis 
STROKE 
A neurological deficit lasting 24 hours or longer.  The stroke shall be based on clinical presentation and 
imaging studies shall be utilized to discern between ischemic versus hemorrhagic origin. The 24-hour 
criterion is excluded if the subject undergoes cerebrovascular surgery or dies during the first 24 hours. The 
definition includes subjects presenting with clinical signs and symptoms suggestive of subarachnoid 
hemorrhage, intracerebral hemorrhage, or cerebral infarction. The definition also includes sudden loss or 
worsening of visual acuity due to retinal artery occlusion or retinal emboli. The definition excludes slowly 
progressive cranial nerve palsies or progressive visual field deficits due to continued aneurysm growth. The 
definition also excludes stroke events in cases of blood disorders such as leukemia or external events such 
as trauma. 
 
Strokes will be categorized as ipsilateral or contralateral and periprocedural (less than or equal to 30 days) 
or late (greater than 30-days from the procedure). A stroke with clinical symptoms that resolves within 24 
hours but with a brain imaging study showing infarction of vascular origin will be considered a minor 
stroke. Stroke severity will be graded by the Investigator as major or minor based on the definitions below: 
 
• 
Permanent: A new neurological deficit which does not resolve completely during the period of 
observation 
• 
Transient: A new neurological deficit which resolves completely during the period of observation 
• 
Major Stroke: A stroke which is associated with an increase in the NIH Stroke Scale by ≥4 
• 
Minor Stroke: A stroke which is associated with an increase in the NIH Stroke Scale by <4 
 

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL 
Aneurysms with the Neuroform Atlas™ Stent System 
Short Study Name: ATLAS 
ATLAS PAS Protocol 
CDM10000880, VerAF 
Page 74 of 74 
SUSPECTED STROKE EVENT 
Any event associated with sudden focal neurological worsening of patient status or stroke neuroimaging 
(e.g., MR or CT) 
SUBARACHNOID HEMORRHAGE (SAH) 
A ruptured cerebral aneurysm causes bleeding into the compartment surrounding the brain 
TARGET ANEURYSM 
A target aneurysm is a qualifying aneurysm treated or attempted to be treated during a stent-assisted coiling 
procedure 
THROMBOEMBOLISM/THROMBOEMBOLIC EVENT 
The blocking of a blood vessel by a particle that has broken away from a blood clot at its site of formation 
THROMBOGENESIS 
The formation of a thrombus 
THROMBUS 
A fibrous clot in the lumen of a blood vessel or inside an aneurysm; it may be occlusive or attached to the 
vessel wall or aneurysmal sac 
TORTUOUSITY 
Marked by repeated twists, bends, or turns 
TRANSIENT ISCHEMIC ATTACK (TIA) 
A brief episode (≤24 hours) of cerebral ischemia that is usually characterized by temporary blurring of 
vision, slurring of speech, numbness, paralysis, or syncope, and that is often predictive of a serious stroke 
VASOSPASM 
Contraction or hypertonia of the muscular coats of a blood vessel 
WIDE NECK ANEURYSM 
Aneurysm having a neck  4 mm or a dome-to-neck ratio of < 2