WEAVE™ Trial: Wingspan StEnt System Post MArket SurVEillance Study
Phase: NA
Conditions: Intracranial Atherosclerosis
Sponsor: Stryker Neurovascular

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WEAVE™ Trial 
Wingspan® StEnt System Post MArket SurVEillance Study 
 
Sponsor: 
Stryker Neurovascular 
47900 Bayside Parkway 
Fremont, CA 94538 
Study Responsibility: 
Lisha Capucion 
Clinical Project Manager 
Stryker Neurovascular  
47900 Bayside Parkway 
Fremont, CA 94538 
Neurointerventional 
Principal Study 
Investigator:  
Michael J. Alexander, MD, FACS 
Neurological Principal 
Study Investigator:  
Wengui Yu, MD, PhD 
Study Centers: 
Up to 50 (US and International) 
Date of Issue: 
18 June 2013 
Date(s) of Amendment(s): 
13 October 2016 
 
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. 

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Investigator’s Signature Page 
STUDY TITLE: 
WEAVE™ 
Trial: 
Wingspan® 
Stent 
System 
Post 
Market 
Surveillance Study 
STUDY CENTER: 
_____________________________________________ 
(Print name of study center) 
I, the undersigned, have read and understand the protocol specified above and agree on its 
content. I agree to perform and conduct the study as described in the protocol. In addition, when 
applicable, I 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 
 
 
Co Principal Investigator (if applicable) 
Print name: 
 
 
Date 
 

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Protocol Synopsis 
WEAVE™ Trial 
Wingspan® StEnt System Post MArket SurVEillance Study 
Study Objective 
Primary 
Objective 
The primary objective of this study is to evaluate the rate of stroke and death in 
patients treated with the Wingspan Stent System, according to the Indications 
for Use, within 72 hours post procedure. 
Study Device 
The Wingspan Stent System includes: 
• 
A self-expanding, nitinol stent with four radiopaque markerbands on 
each end (distal and proximal). 
• 
A flexible over-the-wire stent delivery system (Inner Body and Outer 
Body) with pre-loaded stent. 
• 
The Wingspan Stent System is intended to be used in conjunction with 
the Gateway® PTA Balloon Catheter. 
Device Sizes 
Wingspan Stent Sizes: 
 
Diameters: 2.5, 3.0, 3.5, 4.0, 4.5 mm 
 
Lengths: 9, 15, 20 mm 
Study Design  
Study Design 
Prospective, single-arm, consecutive enrollment, post market surveillance study 
Planned 
Number of 
Patients 
Approximately 389 patients will be required to obtain 350 patients eligible for 
the primary analysis. 
Enrollment rate is expected to be between 75 and 250 patients per year. 
Planned 
Number of Sites  
Maximum number of US or International sites: 50 sites  
Minimum number of Total US or International sites: 30 sites 
Minimum number of US sites: 25 sites 
Primary 
Endpoint 
Stroke or Death within 72 hours of the procedure  
Secondary 
Endpoints 
• Hemorrhagic stroke within 72 hours post procedure 
• Ischemic stroke within72 hours post procedure 
• Neurological death within 72 hours post procedure 
• Stroke recovery at 90 days post procedure 
• Stroke in the territory of the stented artery within 72 hours post procedure 
Follow-Up 
Schedule 
All patients treated with a stent will be assessed at 72 hours post procedure.   

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Any patient treated with a stent who experiences a stroke within 72 hours post 
procedure will be required to complete a Day 30 telephone assessment and a 
Day 90 clinic visit. 
Required 
Medication 
Therapy 
Standard of care for procedure and pre/post operative medication management is 
to be followed. Specific care and attention must be given to achieve therapeutic 
levels of antiplatelet and anticoagulation prior to the procedure without 
inadvertently subjecting the patient to an increased risk of intracerebral 
hemorrhage. 
Key Inclusion / 
Exclusion 
Criteria 
All patients who have a Wingspan stent procedure attempted will be considered 
enrolled in the study.    
Statistical Methods 
Primary 
Statistical 
Hypothesis 
The study aims to evaluate the event rates in the stent group with regard to the 
study endpoints based on the data collected. The study will use data available 
from eligible patients to provide reasonable precision in the event rate 
estimation. 
Statistical Test 
Method 
All patients who have a Wingspan Stent implanted in accordance with the 
Indications for Use will be considered evaluable and analyzed as the primary 
analysis group (Per Protocol cohort (PP)). Descriptive statistical analyses will be 
used for the primary endpoint.   
Logistic regression models will be used to determine if there is a relationship 
between the 72 hour post procedure stroke or death rate and baseline factors. 
 
Periodic interim analyses will be performed to assess the stroke and death rate 
within 72 hours among patients implanted with the Wingspan stent.  Study 
reports will be submitted to the FDA every six months for the first two years 
and annually thereafter.  The reports will include U.S. and international sales 
figures for each six or twelve month period related to the reports. 
Interim analyses for the purpose of stopping this study early will be performed 
after 150, 225, and 300 primary analysis group (Per Protocol Cohort (PP)) 
subjects have been enrolled and have completed their 72-hour post procedure 
follow-up.  If at an interim analysis, there is at least a 95% predictive probability 
of observing no more than 23 events among 350 PP subjects, this trial will stop 
early for statistical success. Alternatively, if at those times the entire two-sided 
95% exact confidence interval of the 72 hour death or stroke rate is above the 
9.7% rate specified in the protocol, then the study will be stopped early for 
safety.   
Sample Size 
Parameters 
The 72 hour stroke and death rate is expected to be approximately 6.6%.  Using 
the Clopper-Pearson exact method with a 95% CI as (0.042, 0.097), with a 
width of 0.055 (±0.0275), 350 evaluable patients will be required.  Enrollment 
of 389 patients is planned for an adequate sample size in the Per Protocol 
analysis group allowing for a 10% attrition rate.   

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Table of Contents 
Protocol Synopsis ......................................................................................................................................................... 3 
Table of Contents ........................................................................................................................................................ 5 
1 
Background and Purpose ............................................................................................................................. 7 
2 
Device Description......................................................................................................................................... 7 
2.1 
Overview .......................................................................................................................................... 7 
2.2 
Indication for Use ............................................................................................................................. 7 
3 
Study Design .................................................................................................................................................. 8 
3.1 
Overview .......................................................................................................................................... 8 
3.2 
Study Objective ................................................................................................................................ 8 
3.2.1 .... Primary Objective .................................................................................................. 8 
3.2.2 .... Secondary Objectives ............................................................................................. 8 
3.3 
Study Endpoints ................................................................................................................................ 9 
3.3.1 .... Primary Endpoint .................................................................................................. 9 
3.3.2 .... Secondary Endpoints ............................................................................................. 9 
4 
Study Population ......................................................................................................................................... 11 
4.1 
Selection Criteria ............................................................................................................................ 11 
4.2 
Withdrawal and Replacement of Patients ....................................................................................... 11 
5 
Study Procedures ........................................................................................................................................ 11 
5.1 
Written Informed Consent .............................................................................................................. 13 
5.2 
Baseline .......................................................................................................................................... 13 
5.3 
Procedure ........................................................................................................................................ 13 
5.4 
Post Procedure Follow Up .............................................................................................................. 14 
5.4.1 .... 72 hours Post Procedure ..................................................................................... 14 
5.4.2 .... Day 4 Post Procedure .......................................................................................... 15 
5.5 
Post Stroke Follow-Up ................................................................................................................... 15 
5.6 
Sample Size Estimate and Justification .......................................................................................... 16 
5.7 
Analysis Populations ...................................................................................................................... 16 
5.7.1 .... Subgroup Analysis ............................................................................................... 17 
5.8 
Statistical Analysis .......................................................................................................................... 17 
5.8.1 .... Statistical Software .............................................................................................. 17 
5.8.2 .... Interim Analyses .................................................................................................. 17 
5.8.3 .... Operating Characteristics ................................................................................... 18 
5.8.4 .... Additional Analysis Methods ............................................................................... 19 
6 
Data Management ....................................................................................................................................... 19 
7 
Monitoring Procedures ............................................................................................................................... 19 

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7.1 
Monitoring ...................................................................................................................................... 19 
7.2 
Auditing .......................................................................................................................................... 20 
7.3 
Device Accountability .................................................................................................................... 20 
8 
Adverse Events ............................................................................................................................................ 20 
8.1 
Adverse Event Definitions and Classification ................................................................................ 20 
8.2 
Reporting Requirements ................................................................................................................. 21 
8.3 
Device Failures, Malfunctions, and Product Nonconformities ....................................................... 21 
8.4 
Known and Anticipated Risks ........................................................................................................ 22 
8.5 
Reporting to Regulatory Authorities / IRBs / IECs / Investigators ................................................. 22 
9 
Ethical Considerations ................................................................................................................................ 23 
9.1 
Compliance with Good Clinical Practices (GCP) ........................................................................... 23 
9.2 
Institutional Review Board/Independent Ethics Committee ........................................................... 23 
9.3 
Written Informed Consent Form ..................................................................................................... 23 
9.4 
Protocol Adherence ........................................................................................................................ 23 
10 
Study Administration ................................................................................................................................. 24 
10.1 
Site Selection .................................................................................................................................. 24 
10.2 
Pre-Study Documentation Requirements ........................................................................................ 24 
10.2.1 .. General ................................................................................................................ 24 
10.2.2 .. Study-specific ....................................................................................................... 24 
10.3 
Record Retention ............................................................................................................................ 24 
10.4 
Criteria for Terminating Study ....................................................................................................... 25 
10.5 
Criteria for Suspending/Terminating a Study Center ...................................................................... 25 
11 
Appendices ................................................................................................................................................... 26 
A. 
Abbreviations .................................................................................................................................. 26 
 
List of Tables 
Table 1. Study Event Schedule .................................................................................................................. 12 
Table 2. Study Event Schedule for Patients who experience stroke within 72 hours……………….... 17 
 
List of Figures 
Figure 1. Schematic of Study Design ......................................................................................... 10 
 

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1 
Background and Purpose 
 
The Wingspan® Stent System with Gateway® Percutaneous Transluminal Angioplasty (PTA) 
Balloon Catheter was approved in the United States (US) under a Humanitarian Device 
Exemption (HDE) and received CE Mark in 2005.  
This study is being conducted to fulfill Food and Drug Administration (FDA) post market safety 
surveillance requirements.  
2 Device Description 
2.1 Overview 
The Wingspan Stent System is a self-expanding, Nitinol stent and delivery system intended 
for use in the treatment of intracranial atherosclerotic disease. The Gateway PTA Balloon 
Catheter is an over-the-wire balloon catheter used to pre-dilate the lesion prior to insertion 
and deployment of the Wingspan Stent System.   
 
 The Wingspan Stent System includes: 
• 
A self-expanding, Nitinol stent with four radiopaque markerbands on each end (distal 
and proximal). 
• 
A flexible over-the-wire stent delivery system (Inner Body and Outer Body) with 
pre-loaded stent. 
• 
The Wingspan Stent System is intended to be used in conjunction with the Gateway 
PTA Balloon Catheter. 
 
Wingspan Stent System 
 
 
 
 
 
 
 
 
 
2.2 Indication for Use 
The Wingspan® Stent System with Gateway® PTA Balloon Catheter is Authorized by 
Federal law for use in improving cerebral artery lumen diameter in patients 22 to 80 years old 
with recurrent (2 or more) strokes refractory to a comprehensive regimen of medical therapy 
and due to atherosclerotic disease of intracranial vessels with 70-99% stenosis that are 
accessible to the system. The most recent stroke must have occurred more than 7 days prior to 

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CDM10000012 v.AB 
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treatment with the Wingspan Stent System. Patients are eligible for treatment with the 
Wingspan Stent System if their modified Rankin Scale score is 3 or less at the time of 
treatment. 
 
The Gateway PTA Balloon Catheter is indicated for balloon dilation of the stenotic portion of 
intracranial arteries prior to stenting for the purpose of improving intracranial perfusion. 
 
The Wingspan Stent System is contraindicated for the following: 
• 
Patients in whom antiplatelet and/or anticoagulation therapy is contraindicated 
• 
Lesions that are highly calcified or otherwise could prevent access or appropriate 
expansion of the stent 
• 
For the treatment of stroke within 7 days or less from the onset of symptoms 
• 
For the treatment of transient ischemic attacks 
3 Study Design 
3.1 Overview 
This is a prospective, single-arm, study of the Wingspan® Stent System and Gateway® PTA 
Balloon Catheter.  Enrollment of approximately 389 patients at a maximum of 50 sites (US or 
International) is planned.  Subject enrollment may stop early for statistical success or safety 
after 150, 225, and 300 primary analysis group subjects have been enrolled and have 
completed their 72-hour post procedure follow-up.  Enrollment rate is expected to be between 
75 and 250 patients per year. 
3.2 Study Objective 
3.2.1 
Primary Objective 
The primary objective is to evaluate the rate of stroke and death within 72 hours in 
patients treated with the Wingspan Stent System in accordance with the Indications 
for Use.   
• 
Ischemic stroke is defined as a neurological deficit that is thought to have an 
ischemic cause and is detectable on examination at least 24 hours after onset of 
symptoms. 
• 
Hemorrhagic stroke is defined as a symptomatic intracerebral, subarachnoid, or 
primary intraventricular hemorrhage. To be considered a hemorrhagic stroke, the 
patient must experience new symptoms (e.g., new severe headache) that last for 
at least 24 hours (symptoms do not need to be associated with a new neurological 
deficit). 
• 
Stroke type (ischemic or hemorrhagic) must be confirmed by imaging. 
3.2.2 
Secondary Objectives 
The secondary objectives are: 
1. To determine the following for any stented patient experiencing a stroke within 
72 hours following the procedure. 
• Required interventions 
• Type of stroke (ischemic or hemorrhagic) 
• Timing of event resolution 

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2. To determine the cause of death for any stented patient that dies within 72 hours 
following the procedure. 
3. To determine if there is a relationship between the post procedure stroke or death 
rate within 72 hours and baseline factors including but not limited to the 
following: 
• 
Level of operator experience at the time of treating their first study patient  
• 
Baseline characteristics (demographics and clinical characteristics) 
• 
Procedural characteristics 
• 
Post procedure patient management 
• 
Operator specialty  
3.3 Study Endpoints 
3.3.1 
Primary Endpoint 
The primary endpoint is the rate of stroke or death within 72 hours of the procedure.  
3.3.2 
Secondary Endpoints 
Secondary endpoints include the following: 
• 
Hemorrhagic stroke within 72 hours post procedure 
• 
Ischemic stroke within 72 hours post procedure 
• 
Neurological death within 72 hours post procedure 
• 
Stroke recovery at 90 days post procedure 
• 
Stroke in the territory of the stented artery within 72 hours post procedure  

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Figure 1. Schematic of Study Design  
 
Treatment with Wingspan planned? 
Informed consent obtained?
Yes
Was the Wingspan stent 
procedure attempted and/or 
arterial site punctured? 
Yes
Subject is now enrolled.
Was the stent implanted?
Yes
Conduct 72 hour post procedure follow-up assessment:
If patient is discharged prior to 72 hours (<64 hours), 
complete all assessments at the time of discharge and 
complete a Day 4 (96 ± 24 hours) Telephone Assessment
Did stroke occur within 72 hours (± 8 hours) of procedure? 
Yes
Yes
Conduct 30-Day Telephone Follow-up
Conduct 90-Day Office Visit  Follow-up
COMPLETE STUDY 
COMPLETION FORM
No
No
Do not enroll or consent patient.
Document patient on Screening Log
No
No
No
Site general requirements for use of device fulfilled: 
 - Operator device training or retraining complete
 - IRB approval for use of device under HDE is 
  current (US only)
Study documentation complete: 
- IRB/IEC approval of protocol and informed consent 
  form obtained
- Study contract executed
- Study training complete
 
 
 
 
 

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4 Study Population 
4.1 Selection Criteria 
All patients for whom treatment with the Wingspan Stent System is considered are eligible 
for enrollment in the study.   
4.2 Withdrawal and Replacement of Patients 
While study withdrawal is discouraged, patients may withdraw from the study at any time, 
with or without reason and without prejudice to further treatment. Withdrawn patients will 
not undergo any additional follow-up, nor will they be replaced.  
 
5 Study Procedures 
The schedule of required observations and assessments are summarized in Tables 1 and 2 below.

 
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Table 1. Study Event Schedule  
Assessment 
Baseline 
Procedure 
Day 3 Office1 Visit 
(72 ± 8 hours from procedure) 
(or at Discharge  
whichever comes first) 
Day 4 Telephone Assessment2  
(96 ± 24 hours from procedure) 
(see footnote below) 
Pre-Treatment  
(Informed Consent) 
X  
 
 
 
Demographics 
X 
 
 
 
Medical History  
X 
 
 
 
Qualifying Events  
X 
 
 
 
Neurological Exam 
X 
 
X 
 
Vital signs 
X 
 
 
 
Target Lesion Assessment 
X 
X 
 
 
Medications 
X 
X 
X 
X 
NIHSS  
X 
 
 
 
Modified Rankin Scale (mRS) 
X 
 
X 
X 
Procedure 
 
X 
 
 
Balloon Use 
 
X 
 
 
Stent Use 
 
X 
 
 
Adverse Events (AE)3 
 
X 
X 
 
Stroke Symptom Assessment 
 
 
 
X 
NIHSS: National Institutes of Health Stroke Scale 
1. For patients who complete the 64 to 80 hour Office Visit (72 + 8 hours), the Day 4 Telephone Assessment is not required.  
2. The Day 4 Telephone Assessment is required for any patient discharged prior to 64 hours post procedure. 
3. Only Neurological AEs, Bleeding/Hemorrhagic AEs (including non-neurological events), groin puncture AEs and AEs that resulted in death 
experienced by the study subject after enrollment are required to be recorded in the CRF. 

 
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5.1 Written Informed Consent  
Written Informed Consent must be obtained for all patients. Patients will be asked 
to sign the Informed Consent form before any study-specific tests or procedures are 
performed. The Informed Consent form is study-specific and must be approved by 
the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).  
 
All patients who sign an informed consent form and have a stenting procedure 
attempted will be considered enrolled in the study at the time of arterial puncture. 
A Screening/Enrollment Log will be maintained to document selection information 
about candidates for whom treatment with the device is planned.  
5.2 Baseline 
The following Baseline data must be collected within 2 weeks prior to the index 
procedure (unless otherwise specified) for all patients and documented in the case 
report form (CRF):  
• 
Demographics and medical history  
• 
Medications 
Physicians will be required to assess and document failed attempts to achieve a 
comprehensive regimen of medical therapy and risk factor management. 
Only antiplatelets, anticoagulants, and medications or supplements taken to 
control blood pressure, lipids, or glucose will be documented in the CRF.   
• 
Vital signs 
• 
Neurological exam 
• 
National Institutes of Health Stroke Scale (NIHSS) score 
• 
Modified Rankin Scale score  
• 
Target lesion characteristics (including imaging findings associated with the 
lesion). 
In addition, information for an alternate contact person(s) will be requested from 
the patient during the consent process to facilitate patient follow up if discharged 
prior to 64 hours post procedure. This information will be provided to the 
Independent Study Neurologist to enable follow up of any patient discharged prior 
to 64 hours post procedure. Additional details on post procedure follow-up can be 
found in Section 5.4. 
5.3 Procedure 
The following procedural data must be collected for all patients and documented on 
the CRF: 
• 
Name of primary operator 
• 
Target lesion characteristics  
• 
Specific devices used 
• 
Procedure start time: Time of access site puncture 
• 
Procedure end time: Time guide catheter removed from access site  

 
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• 
Medications (including pre-operative medication) 
All medications administered in conjunction with the procedure will be 
documented. 
Specific medications used for the stenting procedure (including pre-procedure 
antiplatelets, anesthesia, etc.) and post operative management will be determined 
by the standard of care for patients undergoing neurointerventional procedures at 
each institution.  Specific care and attention must be given to achieve therapeutic 
levels of antiplatelet and anticoagulation prior to the procedure without 
inadvertently subjecting the patient to an increased risk of intracerebral 
hemorrhage.  
For sites that conduct platelet-resistance testing as a pre-operative standard of care, 
details on specific testing and results will be documented. 
 
• 
Activated Clotting Time 
• 
Adverse events 
• 
Device malfunctions 
5.4 Post Procedure Follow Up 
5.4.1 
72 hours Post Procedure 
The following assessments will be performed on all patients with a stent at 72 
hours (± 8 hours) post procedure or at the time of discharge, whichever comes first: 
• 
Neurological exam 
• 
Modified Rankin Scale 
• 
Medications 
All medications administered from procedure end to 72 hours or discharge will be 
recorded. Specific medications for subsequent management of risk factors will be 
at the discretion of the treating physician and will be recorded. 
• 
Adverse events 
The subject may be discharged from the hospital when clinically stable, at the 
Investigator’s discretion. If a patient who received a stent is discharged before 64 
hours post procedure, the study site must immediately notify the Independent 
Stroke Neurologist (ISN) by email of the need to contact the patient for additional 
telephone follow-up on Day 4 (see 5.4.2). Details of the patient’s discharge 
assessment including neurological exam, modified Rankin Scale and medications 
must also be provided to the ISN.  
 
The designated staff at the clinical site will review the study requirements with the 
subject to maximize compliance with the follow-up schedule and any prescribed 
medications. It is imperative that patients understand the need to complete the 
post procedure telephone contact if discharged early.  
 
Patients who are enrolled but do not receive a stent will not be required to have 
study follow up assessments.  

 
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5.4.2 
Day 4 Post Procedure 
Patients who receive a stent and are discharged prior to 64 hours post procedure 
will be contacted by the ISN on Day 4 (96 ± 24 hours post procedure) by telephone 
to ensure that any potential strokes that occurred post discharge are systematically 
identified and documented.  The following assessments will be conducted. 
• 
Stroke symptom assessment 
• 
Modified Rankin Scale 
• 
Medications 
All medications the patient has taken since discharge will be assessed and 
recorded.  
If the patient has experienced any new or worsening symptoms or there is a 
worsening of the modified Rankin score since discharge, the study site will be 
notified by the ISN and the patient will be instructed to contact the study site 
immediately for follow-up.  If the study site determines that the patient experienced 
a stroke within 72 hours of the procedure, the patient must be followed for an 
additional 90 days per Table 2 below.  
If a patient or alternative contact are unable be contacted on Day 4, the ISN will 
make two additional attempts to contact the patient and/or alternate contact up to 
90 days.  Attempts to contact the patient should be documented. 
 
The completed Telephone Assessment Form and/or documentation of attempts to 
contact the patient will be provided to the study site. The ISN or the study site will 
perform entry of the data into the CRF and the site will retain documentation with 
the study files.  
5.5 Post Stroke Follow-Up 
Patients who receive a stent and have a stroke within 72 hours post procedure will 
be followed for 90 days to assess functional outcomes per Table 2 below. If a 
patient has had a stroke within 72 hours and was treated at an outside facility, every 
attempt should be made to obtain medical records and information on the etiology 
and treatment of the stroke.  Post stroke follow up assessments are not required as 
part of the study protocol for patients who have a stroke within 72 hours but did not 
receive a stent.   

 
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CDM10000012 v.AB 
Page 16 of 26 
 
 
        Table 2. Study Event Schedule for Patients who experience stroke within 72 hours1 
Assessment 
Stroke onset 
Day 30 (±7) 
(Telephone) 
Day 90 (±7) 
(Office) 
NIHSS 
X 
 
X 
Imaging2 
X 
 
 
Stroke management3 
X 
 
 
Modified Rankin Scale  
X 
X 
X 
Medications 
 
X 
X 
Adverse Events4 
 
X 
X 
1 Only required for patients who had a stent implanted 
2 Required for any stroke that occurs within 72 hours post procedure to determine 
whether stroke was ischemic or hemorrhagic. 
3 Documentation of interventions and treatment (including medications, devices, etc.) 
administered for acute management and recovery of the stroke.  
4 Only Neurological AEs, Bleeding/Hemorrhagic AEs (including non-neurological 
events), groin puncture AEs and AEs that resulted in death experienced by the study 
subject after enrollment are required to be recorded in the CRF. 
5.6 Sample Size Estimate and Justification 
This study aims to evaluate the rate of stroke or death within 72 hours post 
procedure using data available from eligible patients treated according to the 
Indications for Use (PP cohort) which is expected to be approximately 6.6%.  
Using the Clopper-Pearson exact method with a 95% confidence interval (CI) as 
(0.042, 0.097), with a width of 0.055 (±0.0275), 350 evaluable patients will be 
required.  Enrollment of 389 patients is planned to allow for a 10% attrition rate. 
5.7 Analysis Populations 
Only patients who had a Wingspan Stent implanted in accordance with the 
Indications for Use will be considered evaluable as the primary analysis (PP) 
group.  The Per Protocol cohort will be analyzed for the primary and secondary 
endpoints.  Patients who meet the following criteria at the time of treatment will be 
considered to have been treated according to the Indications for Use. 
 
 
Age 22 to 80 years old, inclusive  
 
70-99% stenosis of an intracranial vessel due to atherosclerotic disease 
 
Experienced recurrent stroke (2 or more) on a comprehensive regimen 
of medical therapy 
 
The most recent stroke occurred more than 7 days prior to treatment 
with the Wingspan system.  
 
Modified Rankin Scale score of 3 or less 

 
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CDM10000012 v.AB 
Page 17 of 26 
 
5.7.1 
Subgroup Analysis 
The primary and secondary endpoints will also be analyzed for the following 
subgroups: 
• 
Patients who have evidence of hemodynamic compromise in the territory of the 
stenotic artery prior to the procedure.  
• 
Patients who present with stroke only in the territory of a perforator artery prior 
to the procedure.  
• 
Patients who are treated not in accordance with the Indications for Use. 
Patients who meet any of the following contraindications will also be 
considered to have been treated not in accordance with the Indications for 
Use and will be included in the sub group analysis: 
 
Patients in whom antiplatelet and/or anticoagulation therapy is 
contraindicated 
 
Lesions that are highly calcified or otherwise could prevent access or 
appropriate expansion of the stent 
 
Patients with an onset of symptoms within 7 days prior to the 
procedure 
 
Patients who have only experienced transient ischemic attacks (TIAs) 
5.8 Statistical Analysis 
Only patients who have a Wingspan Stent implanted in accordance with the 
Indications for Use will be considered evaluable and analyzed as the primary 
analysis (PP) group. Descriptive statistical analyses will be used for the primary 
endpoint.  The percentage rate as well as exact Clopper-Pearson 95% CI will be 
calculated for the rate of stroke or death within 72 hours post procedure for the 
evaluable patients in the study.  For all binary variables, the rate and 95% CI will 
be consistently reported.  For all continuous variables, the standard descriptive 
statistics will be reported, including but not limited to the number of the events or 
patients with non-missing data (N), mean and standard deviation, median and 
interquartiles, and minimum and maximum values. 
5.8.1 Statistical Software 
Primary statistical analyses will be performed, using the SAS System software, 
version 9.2 or above (Copyright © 2000 SAS Institute Inc., SAS Campus Drive, 
Cary, North Carolina 27513, USA. All rights reserved).  Some interim analysis and 
figures may be done with R 3.2.3 or above.  
5.8.2 Interim Analyses 
Interim analyses are planned after 150, 225, and 300 primary analysis group (Per 
Protocol Cohort (PP)) subjects have been enrolled and have completed their 72-
hour follow-up. At the maximum sample size of 350 PP subjects, if the proportion 
of subjects experiencing stroke or death within 72 hours is 6.6%, the upper limit of 
the exact two-sided 95% Clopper-Pearson CI will be 9.7%. 

 
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CDM10000012 v.AB 
Page 18 of 26 
 
This trial may stop early for safety or statistical success.   
For safety, if, at a pre-specified interim analysis, the entire two-sided 95% exact 
confidence interval of the 72 hour death or stroke rate is above the 9.7% rate 
specified in the protocol, then the study will be stopped early for safety. 
For success, if, at a pre-specified interim analysis, there is at least a 95% predictive 
probability of achieving a 95% Clopper-Pearson CI that lies entirely below 9.7% 
with 350 PP subjects.  This translates directly into a 95% predictive probability of 
observing no more than 23 events among 350 PP subjects. 
It is assumed the probability of an event, p, has a Beta prior distribution 
. 
At each interim analysis, the total study sample size, Nmax is the sum of the 
current sample size, Nc, and the number of patients who remain to be enrolled, the 
future sample size, Nf. The number of observed events among the currently 
enrolled patients, Xc, follows a binomial distribution 
. 
The prior distribution is updated with the currently observed data (Xc, Nc) and the 
resulting posterior distribution is 
. 
The number of future events, Xf, among the future patients, Nf, has a beta-binomial 
distribution 
. 
To calculate the predictive probability of achieving a 95% confidence interval that 
lies entirely below 9.7%, or early study statistical success, the probability of 
observing Xf  = y events is calculated from 0 to Nf, among the future subjects, 
where y additional events would result in an early study statistical success or 
 
 
5.8.3 Operating Characteristics 
The performance of these interim analyses were evaluated via simulation across a 
variety of scenarios to evaluate the Type I error and power of this study.  Results 
are based on 5000 simulations per scenario. Under the null hypothesis, where the 
true rate of stroke or death within 72 hours post procedure is 9.7%, the total 
probability of statistical success, either early at an interim analysis or at the final 
analysis with all 350 PP subjects is 3.4%.  This is the overall one-sided Type I error 

 
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CDM10000012 v.AB 
Page 19 of 26 
rate of this trial.  The probability of declaring a success early at one of the interim 
analyses in this scenario is 1.8%.   
This trial is highly likely to stop early for statistical success in the event that rate of 
stroke or death within 72 hours is lower than anticipated.  For example, if the rate 
of stroke or death within 72 hours is 5.5%, there is a 66% probability of declaring 
success early at an interim analysis.  The total probability of success in this 
scenario is 86%.  This is the power of this trial under this alternative hypothesis.   
5.8.4 Additional Analysis Methods 
Logistic regression models will be used to determine if there is a relationship 
between the 72 hour post procedure stroke or death rate and baseline factors 
including but not limited to the following: 
 
• 
Level of operator experience at the time of first patient enrollment  
• 
Baseline characteristics (demographics and clinical characteristics) 
• 
Procedural characteristics 
• 
Post procedure patient management 
• 
Operator specialty 
 
Sufficient baseline information will be collected to assess composite risk of stroke. 
6 Data Management 
Subject data will be collected in a secure electronic data capture (EDC) system. 
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 CRFs. Changes to data previously submitted 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 for appropriate response. The site staff will be 
responsible for resolving all queries in the database. 
7 Monitoring Procedures 
7.1 Monitoring 
Periodic site monitoring visits will be conducted during which original source 
documentation will be reviewed for verification of data entered in the electronic 
database for all patients who have experienced a stroke or death within 72 hours. 
The Investigator/institution guarantees direct access to original source documents 
by Stryker personnel, its designees, and/or appropriate regulatory authorities. In the 
event that the original medical records cannot be obtained for a subject that is seen 
by a non-study physician at a non-study institution, photocopies of the original 
source documents should be made available for review. 
 
It is important that the Investigator and relevant study personnel are available 
during monitoring visits and that sufficient time is devoted to the process. 

 
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CDM10000012 v.AB 
Page 20 of 26 
7.2 Auditing 
The study may also be subject to a quality assurance audit by Stryker or its 
designees, as well as inspection by applicable 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. 
7.3 Device Accountability 
This is a post market surveillance study and sites will use devices from their 
commercially obtained supply of Wingspan Stents and Gateway Balloons. Sites 
will document details of the devices used in the CRF. No additional study-specific 
device accountability procedures are required. 
8 Adverse Events 
8.1 Adverse Event Definitions and Classification 
The following definitions are used in this study: 
Adverse Event (AE): Any untoward medical occurrence in a subject. This 
definition does not imply that there is a relationship between the adverse event and 
the device under investigation. 
Serious adverse event (SAE): An adverse event that:  
• 
led to death 
• 
led to a serious deterioration in the health of the subject that: 
• 
resulted in a life-threatening illness or injury 
• 
resulted in a permanent impairment of a body structure or a body function 
• 
required 
in-subject 
hospitalization 
or 
prolongation 
of 
existing 
hospitalization  
• 
resulted in medical or surgical intervention to prevent permanent impairment to 
body structure or a body function 
• 
led to fetal distress, fetal death or a congenital abnormality or birth defect. 
 
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 the study 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 the device that relates to the rights, safety, or welfare of 
patients. 
 
Only the following AEs experienced by the study subject are required to be 
recorded in the CRF: 
 
• 
Neurological AEs 
• 
Bleeding/Hemorrhagic AEs (including non-neurological events) 
• 
Groin puncture AEs  
• 
AEs resulting in Death (including non-neurological AEs) 
 

 
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CDM10000012 v.AB 
Page 21 of 26 
Death should not be recorded as an adverse event, but should only be reflected as 
an outcome of an AE.  The cause of all deaths that occur during the study should be 
recorded as the AE term with “death” noted as the outcome. In addition, time of 
death should be recorded, if known. 
 
The Investigator will assess the relationship of the adverse event to the study 
devices (i.e., Wingspan and Gateway) as well as the relationship of the event to 
other aspects of the index procedure.  
8.2 Reporting Requirements 
The communication requirements for Adverse Events reporting to Stryker are as 
follows:  
Adverse Event 
Classification 
Communication Method 
to Stryker 
Communication Timeline 
to Stryker 
UADE 
Complete AE eCRF with 
available information 
Within 24 hours of first 
becoming aware of the 
event. 
SAE  
Complete AE eCRF with 
available information 
Within 24 hours of first 
becoming aware of the 
event. 
AE 
Complete AE eCRF page 
As soon as possible 
Device Failures, 
Malfunctions, and 
Product 
Nonconformities 
Complete applicable 
Device eCRF  
Within 24 hours of first 
becoming aware of the 
event. 
8.3 Device Failures, Malfunctions, and Product Nonconformities 
All device failures, malfunctions, and product nonconformities (i.e., Wingspan and 
Gateway) will be documented on the appropriate CRF and the devices should be 
returned to Stryker for analysis. Device failures and malfunctions should also be 
documented in the subject’s medical record. 
 
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 and reported as per 
the requirements in section 8.2. 
 
 
 
 
 
 
 

 
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CDM10000012 v.AB 
Page 22 of 26 
8.4 Known and Anticipated Risks 
Potential adverse events associated with the use of the Wingspan Stent System or 
with the procedure are noted in the DFU.  These include but are not limited to the 
following.  
• 
Aneurysm 
• 
Cerebral ischemia 
• 
Coagulopathy 
• 
Death 
• 
Drug reaction to contrast or antiplatelet medication 
• 
Emboli (air, tissue, or thrombotic tissue) 
• 
Hemorrhagic event 
• 
Hypotension 
• 
Infection 
• 
Intimal dissection 
• 
Ischemia/infarct 
• 
Neurological symptoms 
• 
Restenosis 
• 
Pseudoaneurysm 
• 
Stent migration 
• 
Stent misplacement 
• 
Stent occlusion 
• 
Stent embolization 
• 
Stent thrombosis 
• 
Stroke 
• 
Transient Ischemic Event 
• 
Thromboembolic event 
• 
Vasospasm 
• 
Vessel dissection 
• 
Vessel occlusion 
• 
Vessel perforation 
• 
 Vessel rupture 
• 
Vessel spasm 
• 
Vessel thrombosis 
• 
Vessel trauma requiring surgical repair or intervention 
8.5 Reporting to Regulatory Authorities / IRBs / IECs / Investigators 
Stryker 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/IEC of UADE, 
SAE, and/or adverse events as required by local procedure. A copy of this report 
should be provided to Stryker.  
 
Study reports, which will include the stroke or death rate within 72 hours post 
procedure, will be provided to the Food and Drug Administration (FDA) every six 
months and will include U.S. and international sales figures for each six month 
period related to the report.   

 
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9 Ethical Considerations  
9.1 Compliance with Good Clinical Practices (GCP) 
The Investigator will ensure that this study is conducted in accordance with the 
ethical principles that have their origins in the Declaration of Helsinki and that are 
consistent with GCP and applicable regulatory (local) requirements; whichever 
affords the greater protection to the patient. 
9.2 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 Stryker before 
recruitment of patients into the study. 
 
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 of deviations from the 
protocol or SAEs/UADEs occurring at the site and other SAE/UADE reports 
received from Stryker in accordance with local procedures. 
 
The Investigator is responsible for obtaining annual IRB/IEC approval and renewal 
for the study.  In the U.S., the Investigator is also responsible for IRB approval for 
use of the devices under the HDE throughout the duration of the study. Copies of 
the Investigator’s reports and the IRB/IEC continuance of approval must be sent to 
Stryker. 
9.3 Written Informed Consent Form 
Stryker will provide a sample study 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. 
 
Stryker and the reviewing IRB/IEC must first approve the study Informed Consent 
Form(s) before use. 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 
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. 
 
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. 
9.4 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 

 
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CDM10000012 v.AB 
Page 24 of 26 
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 reason for the deviation and reported to the sponsor.  Sites are responsible 
for reporting protocol deviations to their local IRB/IEC in accordance with local 
guidelines.  
10 Study Administration 
Sites will make every effort to ensure that this study is conducted in compliance with GCP 
and all applicable regulatory requirements. 
10.1 Site Selection 
It is expected that each primary operator shall be able to treat at least 5 patients per 
year with the study device in accordance with the Indications for Use. Site selection 
will attempt to ensure that approximately ⅓ to ½ of participating sites conduct 
platelet-resistance testing as part of standard hospital care to assess any impact of 
testing and subsequent changes in medical therapy can be analyzed. 
10.2 Pre-Study Documentation Requirements 
Prior to screening and enrolling patients in the study, the following requirements 
must be fulfilled: 
10.2.1 General 
Device Training: In accordance with training requirements for the use of the 
Wingspan® Stent System and Gateway® PTA Balloon Catheter as Humanitarian 
Use Devices, all study operators must complete Stryker’s device training program 
on the proper use of the device, proper patient selection and care and consideration 
of intra- and post procedure medications prior to participation in the study.   
 
IRB approval: All US sites must have current IRB approval for use of the 
Wingspan® Stent System with Gateway® PTA Balloon Catheter under the HDE 
and approval must be maintained for continued participation in the study. 
10.2.2 Study-specific 
IRB/IEC approval: All sites must have IRB/IEC approval of the study protocol and 
study consent form. 
Training: All sites must complete training on the protocol and EDC system. 
Clinical Study Agreement: All sites must have a fully executed agreement in place. 
10.3 Record Retention 
The Investigator will maintain all essential trial documents and source 
documentation, in original format, in compliance with the ICH/GCP guidelines. 
Documents must be retained for at least 2 years after FDA acceptance of the final 
report. These documents may be retained for a longer period of time per agreement 
with Stryker or in compliance with other regulatory requirements.  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 documents, custody must be transferred to an individual who 

 
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CDM10000012 v.AB 
Page 25 of 26 
will assume responsibility. Stryker must receive written notification of this 
custodial change.  
10.4 Criteria for Terminating Study 
Stryker reserves the right to terminate the study and intends only to exercise this 
right for valid scientific or administrative reasons and reasons related to protection 
of patients. Investigators and associated IRB/IECs will be notified in writing in the 
event of termination. 
10.5 Criteria for Suspending/Terminating a Study Center 
Stryker reserves the right to stop the enrollment of patients at a study center if no 
patients have been enrolled in 6 consecutive months or if the center has multiple or 
severe protocol violations without justification or fails to follow remedial actions. 
Stryker also reserves the right to investigate any single occurrence or multiple 
occurrences of procedure related serious adverse events or technical difficulties.  
Outcomes of these investigations may range from no action to re-
training/proctoring, suspension or termination of the operator or site.   
 

 
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11 Appendices 
A. Abbreviations  
AE 
Adverse Event 
CRF 
Case Report Form 
DFU 
Directions for Use 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HDE 
Humanitarian Device Exemption 
ICAD 
Intracranial Atherosclerotic Disease 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IEC 
Institutional Ethics Committee 
IRB 
Institutional Review Board 
ISN 
Independent Stroke Neurologist 
mRS 
Modified Rankin Scale 
NIHSS 
National Institutes of Health Stroke Scale 
PTA 
Percutaneous Transluminal Angioplasty 
PTAS 
Percutaneous Angioplasty And Stenting 
SAE 
Serious Adverse Event 
TIA 
Transient Ischemic Attack 
UADE 
Unanticipated Adverse Device Effect 
US 
United States