GORE® Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events From Carotid Endarterectomy
Phase: NA
Conditions: Carotid Artery Disease, Carotid Artery Stenosis
Sponsor: W.L.Gore & Associates

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Nothing herein is to be disclosed in any way without the prior 
expressed written permission of W. L. Gore & Associates, Inc. 
 
 
 
 
 
GORE® Carotid Stent Clinical Study for the treatment of carotid artery 
stenosis in patients at increased risk for adverse events from carotid 
endarterectomy 
 
The Gore SCAFFOLD Clinical Study 
 
 
 
 
 
Protocol Number: 
 
GCS 10-08 
 
 
 
 
 
 
 
Amendment 3:                        22 OCT 2014 
Amendment 2:                        10 JUL 2013 
Amendment 1:                        04 FEB 2013 
Original Protocol:  
   10 FEB 2012 
 
 
 
 
 
 
 
 
 
 
W. L. Gore & Associates, Inc. 
Medical Products Division 

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Protocol Modification Summary 
 
List of Changes in: GORE® Carotid Stent Clinical Study for the treatment of carotid artery stenosis in 
patients at increased risk for adverse events from carotid endarterectomy – The Gore SCAFFOLD 
Clinical Study GCS 10-08 
 
The following clarification changes have been made to the protocol: 
               
              Changes from Amendment 2: 10 JUL 2013 to Amendment 3: 22 OCT 2014 
Section 
Changes to Protocol 
Rationale 
Throughout the document 
Header changed:  
Current Version: 
GORE® Carotid Stent 
MD134865 GCS 10-08 PROT 
Revision#:1 Doc Type SP 
 
 
Previous Version:  
GCS 10-08 13-07-10      
GORE® Carotid Stent  
 
Update to current protocol 
date and updated template 
Throughout the document 
Footer changed:  
Current Version: 
MD133246 Protocol Template 
Revision#1 
Doc Type: GC 
 
 
Previous Version:  
TMPLT 11-05-27 Protocol 
APP.doc 
PROT 14-10-XX GCS 10-08 
APP.doc  
 
Update to current protocol 
date and updated template 
Cover Page 
Addition of Amendment 3: 22 
OCT 2014 
Update to current protocol 
date 
Protocol Summary 
Addition of Amendment 3: 22 
OCT 2014 
Update to current protocol 
date 
Protocol Summary 
Removed Europe and Japan 
from “Number of Clinical 
Investigative Sites” 
Update to reflect study will be 
in the U.S. only.  
List of Abbreviations 
Removed European Union and 
Pharmaceuticals and Medical 
Devices Agency (Japan) 
Update to reflect study will be 
in the U.S. only. 
Section 3.1 Description of 
Study Design 
Removed reference of Europe 
and Japan from second 
paragraph and reference of 
Update to reflect study will be 
in the U.S. only. 

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“PMDA” and “Shonin” approval 
Section 4.1  Description of 
Population 
Addition of:  The study has 
been designed with standard 
eligibility criteria to address any 
known or foreseeable factors 
that may compromise the 
outcome of the study or the 
interpretation of results.  
 
Updated to reflect the current 
protocol template wording. 
Section 4.3 Exclusion 
Criteria – Angiographic 
Exclusion Criteria 
Current version: Patient has a 
previously placed arterial stent 
distal to or including the origin 
of the ipsilateral great vessel 
(includes a stent anywhere in 
the ICA, CCA, or 
brachiocephalic artery).  
 
 
Previous version: Patient has 
previously placed stent in the 
ipsilateral carotid artery. 
Subjects who have a stent in 
the ipsilateral side to target 
lesion will be excluded. This 
includes internal and 
common carotid arteries as 
well as the innominate artery 
if applicable.  
Section 4.3 Exclusion 
Criteria – Angiographic 
Exclusion Criteria 
Current version: Patient has 
known mobile plaque, 
thrombus, or excessive 
calcification in the aortic arch. 
 
Previous version: Patient has 
known mobile plaque or 
thrombus in the aortic arch. 
 
 
Subjects who have excessive 
calcification in the arch will 
be excluded 
Section 4.3 Exclusion 
Criteria – Angiographic 
Exclusion Criteria 
Addition of Exclusion Criteria 
#9: Patient has aneurysmal 
carotid bifurcation on the 
ipsilateral side. 
Additional criteria included to 
exclude subjects with 
aneurysmal carotid 
bifurcation on the treatment 
side. 
Section 4.3 Exclusion 
Criteria – Angiographic 
Exclusion Criteria 
Addition of Exclusion Criteria 
#10: Patient has tortuous 
anatomy or disease 
morphology which would 
prohibit the safe placement of 
guide catheter, sheaths, 
embolic protection systems or 
stent systems within the access 
or target vessel 
Additional criteria included to 
exclude subjects with 
tortuous anatomy that will 
prevent safe introduction of 
interventional  
equipment. 
 
 
 
 

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Section 5.1 Study 
Procedures and Evaluation 
Schema 
Addition of :  “Obtain review by 
Screening Committee” 
Update to reflect current 
process for Screening 
Committee review.  
Section 5.2 Schedule of 
Events 
Multiple changes to reflect new 
screening process. 
Update to reflect current 
process for Screening 
Committee review. 
Section 5.3 Informed 
Consent Process 
Current version: All patients 
must provide written informed 
consent prior to submission of 
pre-procedure imaging and 
medical history to the 
Screening Committee for 
review (refer to Section 5.5 for 
details) and prior to and study 
related procedures being 
performed. 
 
Previous version: All patients 
must provide written informed 
consent prior to any study 
related procedure being 
performed.  
Update to reflect current 
process for Screening 
Committee review. 
Section 5.5 Pre-
Screening/Screening 
Current version: Inclusion and 
exclusion criteria assessed: 
confirmation is required by 
Screening Committee 
 
Previous version: Inclusion and 
exclusion criteria assessed. 
Update to reflect current 
process for Screening 
Committee review. 
Section 5.5 Pre-
Screening/Screening 
Addition of: “Angiography 
and/or CTA” as a requirement 
for the Pre-
Screening/Screening visit 
Update to reflect current 
process for Screening 
Committee review. 
Section 5.5 Pre-
Screening/Screening 
Addition of:  
Pre-screening Assessment 
A Screening Committee will 
review pre-operative 
angiography and/or CTA, along 
with patient medical history, for 
assessment of entry criteria, 
and approval prior to the study 
procedure.    
The Screening Committee will 
be comprised of an 
interdisciplinary team of study 
investigators with pertinent 
Update to reflect current 
process for Screening 
Committee review. 

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knowledge in carotid stenting. 
The members will not review 
potential cases from their own 
sites. The members will be 
compensated for their 
involvement in the Screening 
Committee, including 
reimbursement for reasonable 
travel expenses to attend 
meetings.   
 
This committee will operate 
under pre-specified procedures 
as outlined in the Screening 
Committee Charter.    
 
Prior to a patient being enrolled 
in the study, the investigational 
site must receive confirmation 
from the Screening Committee 
that the subject is eligible to be 
enrolled. Although patient may 
be deemed eligible to be 
enrolled, it is still the 
responsibility of the 
investigator to assess all 
inclusion and exclusion criteria 
prior to enrollment. 
 
Screening Angiogram and/or 
CTA 
In addition to review of medical 
history, patients will be 
screened by the Screening 
Committee based on the 
results of an angiogram or 
CTA. These images must 
include at a minimum the aortic 
arch, ipsilateral carotid artery, 
target lesion, and intracranial 
and extracranial views. A 
complete diagnostic study will 
be needed in order to evaluate 
fully the patient against entry 
criteria. Submission of 
complete case images is 
strongly encouraged.  

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Section 5.6 Pre-Procedure 
Assessments 
Current version: Baseline 
Cardiac Enzyme -Troponin 
(may be obtained once arterial 
access is gained but not after 
any interventional wires enter 
the subject’s vasculature 
 
Previous version: Baseline 
Cardiac Enzyme (Troponin)  
Added additional clarification 
as to when cardiac Troponin 
may be drawn. 
Section 5.6 Pre-Procedure 
Assessments 
Current version : Concomitant 
Medications (antiplatelet and 
anticoagulant therapy) 
 
Previous version:  
x Concomitant medications 
x Assess Antiplatelet Therapy 
Clarify which medications are 
being collected 
Section 5.7 Procedure 
Current version : Concomitant 
Medications (antiplatelet and 
anticoagulant therapy) 
 
Previous version:  
Concomitant medications 
Clarify which medications are 
being collected 
Section 5.10 Post-Procedure 
Current version : Concomitant 
Medications (antiplatelet and 
anticoagulant therapy) 
assessment 
 
Previous version:  
Concomitant medications 
Clarify which medications are 
being collected 
Section 5.11 Follow-Up 
Current version : Concomitant 
Medications (antiplatelet and 
anticoagulant therapy) 
assessment 
 
Previous version:  
Concomitant medications 
assessment 
Clarify which medications are 
being collected 
Section 6.4 Core Labs 
Current Version:  
 
 
 
 
Update to reflect change in 
address for 
. 

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Previous Version: 
 
 
 
 
 
Section 6.5 Protocol 
Deviations 
Current Version:  A Protocol 
Deviation is defined as any 
change, divergence, or 
departure from the study 
design or procedures of a 
research protocol. The 
Investigator is responsible for 
promptly reporting Protocol 
Deviations to their reviewing 
IRB per IRB policy and the 
Sponsor.   
 
Previous Version:  A protocol 
deviation is defined as any 
change, divergence, or 
departure from the study 
design or procedures of a 
research protocol that is under 
the Investigator’s control and 
that has not been approved by 
the IRB/EC. The Investigator is 
responsible for promptly 
reporting protocol deviations to 
their IRB/EC per IRB/EC policy 
and the Sponsor.  
Update to reflect the current 
protocol template wording 
Sections 6.5, 6.6, 6.8, and 
6.9 
Removed all ‘EC’ from IRB/EC 
regulatory references  
Update to reflect study will be 
in the U.S. only. 
Section 6.9 
Current version: 
Records will be maintained 
during the clinical study and for 
a minimum of two years after 
the latter of the date on which 
the study is terminated or 
completed, or the date the 
records are no longer required 
to support regulatory approval 
of the device.   
 
Update to reflect the current 
protocol template wording. 

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Previous version:   
Records will be maintained 
during the clinical study and 
three years after the day on 
which marketing authorization 
of the investigational device is 
obtained or three years after 
the date of discontinuation or 
completion of the clinical trial, 
whichever comes later. 
Section 9.1.1 Adverse Event 
Relationship 
Addition of:  Only one primary 
relationship will be assigned to 
each reported AE. 
Study Device-related 
Current version: 
The functioning or 
characteristics of the device 
caused or contributed to the 
Adverse Event. 
 
Previous version: 
If the functioning or 
characteristics of the stent 
caused or contributed 
significantly to the adverse 
event, the adverse event would 
be suspected as primarily 
related to the stent.   
 
Embolic Protection System 
(EPD)-related 
Current version: 
The functioning or 
characteristics of the EPD 
caused or contributed to the 
Adverse Event.   
 
Previous version: 
If the functioning or 
characteristics of the EPD 
caused or contributed 
significantly to the adverse 
event, the adverse event would 
be suspected as primarily 
related to the EPD.   
Update to reflect the current 
protocol template wording. 
 
Update to reflect the current 
protocol template wording. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Update to reflect the current 
protocol template wording. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Procedure-related 
Current version:  
The study index procedure 
(and not the device or EPD) 
caused or significantly 
contributed to the Adverse 
Event. 
 
Previous version:  
If the procedure (and not the 
device) caused or significantly 
contributed to the adverse 
event, the adverse event would 
be suspected as primarily 
related to the procedure.  
 
Medication-related 
Current version: 
The Adverse Event was a 
result of medical therapy 
prescribed by the study 
protocol and not the device, 
EPD, or procedure.   
 
Previous version: 
If the adverse event was a 
result of a medication taken as 
part of the study/procedure, the 
adverse event would be 
suspected as primarily related 
to the medication. 
 
Disease-related 
Current version: 
The Adverse Event was a 
result of the underlying disease 
progression for which the study 
procedure is being performed, 
and not the device, EPD or 
procedure. 
 
Previous version: 
If the adverse event was a 
 
 
Update to reflect the current 
protocol template wording. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Update to reflect the current 
protocol template wording. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Update to reflect the current 
protocol template wording. 
 
 
 
 
 
 
 
 
 
 

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result of the underlying disease 
progression for which the study 
procedure is being performed, 
and not the device or 
procedure, the adverse event 
would be suspected as 
primarily related to the disease. 
 
Not related 
Current version: 
An Adverse Event which 
cannot be attributed to the 
device, EPD, procedure, 
medication or disease.   
 
Previous version: 
If an adverse event cannot be 
attributed to the device, 
procedure, medication, or 
disease, it will be reported as 
“Not related”. 
 
Unknown relationship 
Current version: 
The relationship of the Adverse 
Event to the device, EPD, 
procedure, medication or 
disease cannot be determined. 
 
Previous version: 
If the relationship of the 
adverse event to the device, 
procedure, medication, or 
disease cannot be determined, 
it will be coded as “Unknown”. 
 
 
 
 
 
 
 
 
Update to reflect the current 
protocol template wording. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Update to reflect the current 
protocol template wording. 
 
Section 9.2  Unanticipated 
Adverse Device Effect 
(UADE) 
Removed ‘EC’ from IRB/EC 
regulatory references 
 
Addition of:  A report from the 
Sponsor will be submitted to 
the FDA and to all reviewing 
IRBs and participating 
Investigators within 10 working 
days after the Sponsor first 
receives notice of the effect. 
Update to reflect study will be 
in the U.S. only. 
 
Update to reflect the current 
protocol template wording. 
 

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Section 10.4.3 Analysis Sets 
Current Version: The primary 
analysis set for testing of the 
primary endpoint is the per-
protocol analysis set. 
 
Previous Version: The primary 
analysis set for testing of the 
primary endpoint is the intent-
to-treat, or full, analysis set. 
Because subjects with 
technical failure are followed 
only to 30 days, they will not 
be evaluable for the primary 
endpoint. The ITT set 
includes technical failures; 
the per-protocol set does not.
Section 10.4.3 Intent-To-
Treat Analysis Set 
Current Version: The ITT 
analysis set is defined as all 
enrolled subjects with adequate 
informed consent, regardless of 
whether the study stent was 
implanted. Because technical 
failures (test device attempted 
but not implanted) are followed 
only to 30 days, this set will be 
used in the analysis of safety 
endpoints (major, serious, and 
nonserious adverse events) to 
30 days and secondary 
endpoints evaluated at 
procedure, discharge, and 30 
days. 
Previous Version: The ITT 
analysis set is defined as all 
enrolled subjects with adequate 
informed consent, regardless of 
whether or not the study stent 
was implanted. This set will be 
used in the analysis of the 
primary and all secondary 
endpoints evaluated at 
procedure, 30 days and one 
year, as well as supplemental 
analyses of the primary 
endpoint (for example, Kaplan-
Meier survival analysis). 
Same as above. 
Section 10.4.3 Per-Protocol 
Analysis Set (Primary 
Analysis Set) 
Current Version: For per-
protocol analysis, only subjects 
who had the study stent 
implanted in the target vessel 
and had no major protocol 
deviations will be included in 
the analysis. Major protocol 
deviations are defined as 
protocol deviations with a level 
Same as above, plus 
clarification to definition of 
major protocol deviation. 

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of seriousness such that 
inclusion of the subject(s) 
would unacceptably bias the 
primary endpoint analysis. An 
example of a major protocol 
deviation might be failure to 
satisfy eligibility criteria to a 
degree where the subject does 
not fit the underlying scientific 
model for the treatment. 
The per-protocol set will be 
used for the primary analyses 
of the primary endpoint. Ideally, 
this analysis set will consist of 
all subjects from the ITT set 
with technical success (test 
device implanted). 
 
Per-Protocol Analysis Set 
(Primary Analysis Set) 
 
Previous Version: For per-
protocol analysis, only subjects 
who had the study stent 
implanted in the target vessel 
and had no major protocol 
deviations will be included in 
the analysis. Anticipated major 
protocol deviations are defined 
as any of the following: 
x 
Subject does not satisfy 
inclusion/exclusion criteria 
x 
Inadequate informed 
consent 
 
Per-Protocol Analysis Set 

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11.1 Statement of 
Compliance 
Removed reference “so that 
global data can be used for 
submission in the U.S. and 
Japan” 
 
Removed the following local 
regulatory requirements: 
2005 Ministry 
of Health, 
Labor and 
Welfare 
Ordinance 
No.36 
Ministerial 
Ordinance 
on Good 
Clinical 
Practice for 
Medical 
Devices 
Medical 
Device 
Directive 
(93/42/EEC) 
Article 15 
Annex X 
Council 
Directive 
93/42/EEC 
of 14 June 
1992 
Amendment 
to the MDD 
(2007/47/EC)
Article 15 
Annex X 
Directive 
2007/47/EC 
of the 
European 
Parliament 
and of the 
Council of 5 
September 
2007 
 
Removed the following 
sentence:  The Sponsor will 
obtain clinical trials insurance 
as required by the laws of each 
country in which the study is 
conducted. 
Update to reflect study will be 
in the U.S. only. 
 
 
 
Update to reflect study will be 
in the U.S. only. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Update to reflect study will be 
in the U.S. only. 
 
Section 11.2  Compliance 
Responsibilities 
Removed all ‘EC’ from IRB/EC 
regulatory references 
 
Removed Caretaker office 
location in Japan 
Update to reflect study will be 
in the U.S. only. 
 
Update to reflect study will be 
in the U.S. only. 
Sections 11.3, 11.4 and 11.6 
Removed all ‘EC’ from IRB/EC 
regulatory references 
 
Update to reflect study will be 
in the U.S. only. 
 
 

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PROTOCOL SUMMARY 
Study Title 
GORE® Carotid Stent Clinical Study for the treatment of 
carotid artery stenosis in patients at increased risk for 
adverse events from carotid endarterectomy 
Protocol Number 
GCS 10-08 
Amendment 3 
22 OCT 2014 
Amendment 2 
10 JUL 2013 
Amendment 1 
04 FEB 2013 
IDE Number 
G110127 
Sponsor 
W. L. Gore & Associates, Inc.  
Medical Products Division 
4250 West Kiltie Lane 
Flagstaff, AZ  86001 
Telephone: 800-437-8181 
Study Design 
Multicenter, single-arm, prospective study comparing the 
GORE® Carotid Stent to a performance goal developed 
from carotid endarterectomy (CEA) outcomes 
Study Objective 
To evaluate the safety and effectiveness of the GORE® 
Carotid Stent for the treatment of carotid artery stenosis in 
patients at increased risk for adverse events from carotid 
endarterectomy. 
Study Endpoints 
Primary Endpoint: 
Major Adverse Event (MAE) rate defined as a composite of: 
x 
Death, stroke, or MI through 30 days post-index 
procedure, and 
x 
Ipsilateral stroke from Day 31 through 1 year 
Secondary Endpoints: 
x 
Stent Technical Success 
x 
Embolic Protection Technical Success 
x 
Procedure Success 
x 
In-Stent Restenosis 
x 
Target Lesion Revascularization 
Subject Population 
Patients at least 18 years of age who have either de novo 
atherosclerotic or postendarterectomy restenotic lesions in 
the internal carotid arteries or at the carotid bifurcation, with 
either ≥50% (by angiography) stenosis if symptomatic 
(stroke, TIA, TMB within 180 days of procedure), or ≥80% 
(by angiography) stenosis if asymptomatic.  Patients must 
have either anatomic or medical co-morbidities that place 
them at high perioperative risk for CEA. 
Number of Subjects 
312 
Number of Clinical 
Investigative Sites 
Up to 50 sites in the U.S. 
Study Duration  
Time to Complete Enrollment:  18-24 months 
Follow-up Time:  36 months 
Total Study Duration:  54-60 months 

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Follow-up Schedule 
Screening, Pre-procedure, Procedure, Post-Procedure, 30 
days, 6 months, 1 year, 2 years, and 3 years 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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LIST OF ABBREVIATIONS 
ACT 
Activated Clotting Time 
AE 
Adverse Event 
BUN 
Blood Urea Nitrogen 
CAS 
Carotid Artery Stenting 
CBC 
Complete Blood Count 
CCA 
Common Carotid Artery 
CDUS 
Carotid Duplex Ultrasound 
CDMS 
Clinical Data Management System 
CEA 
Carotid Endarterectomy 
CEC 
Clinical Events Committee 
CFR 
Code of Federal Regulations 
CHF 
Congestive Heart Failure 
Cm 
Centimeters 
COPD 
Chronic Obstructive Pulmonary Disease 
CRF 
Case Report Form 
CT 
Computed Tomography 
CTA 
Computed Tomographic Angiography 
DSMB 
Data and Safety Monitoring Board 
EC 
Ethics Committee 
ECA 
External Carotid Artery 
eCRF 
Electronic Case Report Form 
ECG 
Electrocardiogram 
ePTFE 
Expanded Polytetrafluoroethylene 
FDA 
Food and Drug Administration (United States) 
Fr 
French (sizing) 
GCP 
Good Clinical Practice 
HIT 
Heparin-Induced Thrombocytopenia 
ICA 
Internal Carotid Artery 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IDE 
Investigational Device Exemption 
IFU 
Instructions for Use 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board (U.S.) 
LVEF 
Left Ventricular Ejection Fraction 
MI 
Myocardial Infarction 
mm 
Millimeters 
MRA 
Magnetic Resonance Angiography 
MRI 
Magnetic Resonance Imaging 
NASCET 
North American Symptomatic Carotid Endarterectomy Trial 

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NIHSS 
National Institute of Health Stroke Scale 
NYHA 
New York Heart Association 
PFO 
Patent Foramen Ovale 
PG 
Performance Goal 
PMA 
Premarket Approval 
SAE 
Serious Adverse Event 
TIA 
Transient Ischemic Attack 
TLR 
Target Lesion Revascularization 
UADE 
Unanticipated Adverse Device Effect 
 
 
 

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1. 
INTRODUCTION .........................................................................................................................................20 
1.1. DISEASE ................................................................................................................................................20 
1.2. HISTORICAL TREATMENTS .......................................................................................................................20 
1.3. STUDY DEVICE DESCRIPTION ...................................................................................................................21 
1.4. GORE EMBOLIC PROTECTION SYSTEMS ....................................................................................................23 
2. 
STUDY OBJECTIVES .................................................................................................................................23 
2.1. PRIMARY OBJECTIVE(S) ..........................................................................................................................23 
3. 
STUDY DESIGN ..........................................................................................................................................23 
3.1. DESCRIPTION OF STUDY DESIGN ..............................................................................................................23 
3.2. STUDY ENDPOINTS .................................................................................................................................24 
3.2.1. 
Definitions ..................................................................................................................................24 
3.2.2. 
Primary Endpoint .......................................................................................................................25 
3.2.3. 
Secondary Endpoints ................................................................................................................25 
4. 
STUDY POPULATION ................................................................................................................................26 
4.1. DESCRIPTION OF POPULATION .................................................................................................................26 
4.2. INCLUSION CRITERIA...............................................................................................................................26 
4.3. EXCLUSION CRITERIA .............................................................................................................................27 
5. 
STUDY PROCEDURES/EVALUATIONS.....................................................................................................29 
5.1. STUDY PROCEDURES AND EVALUATION SCHEMA ......................................................................................29 
5.2. SCHEDULE OF EVENTS ............................................................................................................................30 
5.3. INFORMED CONSENT PROCESS ................................................................................................................31 
5.4. GENERAL STUDY EVALUATION GUIDELINES ..............................................................................................31 
5.5. PRE-SCREENING/SCREENING ..................................................................................................................31 
5.6. PRE-PROCEDURE ASSESSMENTS.............................................................................................................33 
5.7. PROCEDURE ..........................................................................................................................................34 
5.8. ENROLLMENT .........................................................................................................................................34 
5.9. REPEAT INTERVENTIONS .........................................................................................................................37 
5.10. 
POST-PROCEDURE .........................................................................................................................37 
5.11. 
FOLLOW-UP ..................................................................................................................................37 
5.12. 
SUBJECT WITHDRAWAL FROM THE CLINICAL STUDY ..........................................................................38 
5.13. 
SUBJECT LOST TO FOLLOW-UP .......................................................................................................38 
5.14. 
SUBJECT STUDY COMPLETION ........................................................................................................39 
5.15. 
EXPLANT PROCEDURES ..................................................................................................................39 
6. 
CLINICAL STUDY ADMINISTRATION ........................................................................................................39 
6.1. DEVICE TRAINING ...................................................................................................................................39 
6.2. MONITORING ..........................................................................................................................................39 
6.3. DEVICE ACCOUNTABILITY AND STORAGE ..................................................................................................40 
6.4. CORE LABS ...........................................................................................................................................40 
6.5. PROTOCOL DEVIATIONS ..........................................................................................................................41 
6.6. PROTOCOL AMENDMENTS .......................................................................................................................41 
6.7. SPONSOR REPRESENTATIVES ..................................................................................................................41 
6.8. ACCESS TO SOURCE DATA/DOCUMENTS ..................................................................................................42 
6.9. STUDY RECORDS RETENTION ..................................................................................................................42 
7. 
DATA COLLECTION AND SUBMISSION ...................................................................................................43 
7.1. DATA COLLECTION METHODS ..................................................................................................................43 
7.2. DATA CLARIFICATION AND CORRECTION...................................................................................................43 
7.3. CRF COMPLETION SCHEDULE .................................................................................................................43 

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8. 
RISK ASSESSMENT ..................................................................................................................................44 
8.1. POTENTIAL RISKS ..................................................................................................................................44 
8.2. MINIMIZATION OF RISKS ..........................................................................................................................46 
8.3. SUMMARY OF EXPECTED BENEFITS ..........................................................................................................46 
9. 
ADVERSE EVENTS AND SAFETY MONITORING .....................................................................................47 
9.1. ANTICIPATED ADVERSE EVENTS ..............................................................................................................47 
9.1.1. 
Adverse Event Relationship ......................................................................................................47 
9.1.2. 
Adverse Event Classification ....................................................................................................48 
9.1.3. 
Adverse Event Reporting and Coding.......................................................................................48 
9.1.4. 
Subject Death .............................................................................................................................49 
9.2. UNANTICIPATED ADVERSE DEVICE EFFECTS (UADE) ................................................................................49 
9.3. DATA AND SAFETY MONITORING BOARD ..................................................................................................50 
9.4. CLINICAL EVENTS COMMITTEE .................................................................................................................50 
10. 
STATISTICAL ANALYSIS...........................................................................................................................51 
10.1. 
STUDY HYPOTHESES ......................................................................................................................51 
10.2. 
SAMPLE SIZE ASSUMPTIONS ...........................................................................................................51 
10.3. 
SAMPLE SIZE DETERMINATION ........................................................................................................53 
10.4. 
DATA ANALYSIS.............................................................................................................................55 
10.4.1. 
Timing of Analyses ....................................................................................................................55 
10.4.2. 
Analysis Populations .................................................................................................................55 
10.4.3. 
Pooling of Data ...........................................................................................................................56 
10.4.4. 
Statistical Analysis of Primary Endpoint(s) ..............................................................................56 
10.4.5. 
Sensitivity Analyses ..................................................................................................................56 
10.4.6. 
Statistical Analysis of Secondary Endpoint(s) .........................................................................56 
10.5. 
PUBLICATION PLAN ........................................................................................................................56 
11. 
ETHICAL AND REGULATORY CONSIDERATIONS ..................................................................................57 
11.1. 
STATEMENT OF COMPLIANCE ..........................................................................................................57 
11.2. 
COMPLIANCE RESPONSIBILITIES ......................................................................................................57 
11.3. 
INFORMED CONSENT ......................................................................................................................58 
11.4. 
INDEPENDENT ETHICAL REVIEW ......................................................................................................58 
11.5. 
CONFLICT OF INTEREST ..................................................................................................................58 
11.6. 
CONFIDENTIALITY...........................................................................................................................58 
12. 
REFERENCES ............................................................................................................................................59 
13. 
STUDY-SPECIFIC APPENDICES ...............................................................................................................61 
APPENDIX A NIH STROKE SCALE ...................................................................................................................61 
APPENDIX B MODIFIED RANKIN SCALE ............................................................................................................61 
  
 

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1. 
Introduction  
1.1. Disease 
It has been estimated that carotid artery disease accounts for 20-30% of the greater than 
500,000 new strokes that occur annually in the United States1. As stroke is the leading cause 
of serious, long-term disability in the United States, treatment of carotid artery disease may 
diminish part of the $53.6 billion yearly health care costs associated with the treatment of 
stroke2.   
1.2. Historical Treatments  
Treatment options for carotid artery disease include the current standard of care, carotid 
endarterectomy (CEA), medical therapy, and the continuously evolving procedure of carotid 
artery stenting (CAS). 
 
CEA remains the gold standard as an effective technique for the treatment of chronic carotid 
artery stenosis associated with stroke.  The technique is endorsed by the American Heart 
Association (AHA) as a first-line therapy for symptomatic subjects with recent cerebral 
ischemia and carotid artery diameter stenosis exceeding 70% and for carotid stenosis 
exceeding 60% in asymptomatic subjects with surgical risk less than 3% and a life expectancy 
of at least 5 years1,3. However, for CEA to provide a greater benefit than medical therapy, the 
combined morbidity and mortality rate should be under 3% for asymptomatic subjects and less 
than 6% for symptomatic subjects4. 
 
In patients at high risk for complications during CEA, such as those with anatomic or 
physiologic co-morbidities, outcomes with surgery are less well defined and in some cases 
documented to be worse than the standard surgical risk patient5.  In these cases CAS has 
been shown to be a potentially safer and equally effective stroke reduction therapy6.   
Furthermore, high surgical risk registry data have demonstrated a continued reduction in 
stroke/MI/death rates over the last several years suggesting that as technique, patient 
selection, and technology improves, so do outcomes7,8. In the standard risk patient, the 
recently released results of the Carotid Revascularization Endarterectomy vs. Stent Trial 
(CREST) study found equivalence between the two strategies in terms of the primary endpoint 
of death, stroke, and myocardial infarction to 30 days plus ipsilateral stroke to 4 years9. 
 
Advantages and Disadvantages with Current Carotid Stents 
 
Closed Cell vs Open Cell 
Currently, the stents available for CAS are divided into two types; Closed-Cell and Open-Cell.  
Locally approved Closed-Cell stents, such as the Xact® Carotid Stent System (Abbott 
Vascular, Santa Clara, CA) or the Wallstent® Monorail® System (Boston Scientific 
Corporation Natick, MA) are characterized by individual apices of the stent frame being 
connected by a strut to the apices in the adjacent row and is further characterized by each of 
the individual apices having a smaller cell size.  The obvious benefit from such a design is that 
the stent provides a higher degree of plaque stabilization, thus minimizing plaque protrusion 
through the stent struts and maintaining greater contact with the vessel wall.  However, such a 
design is typically considered to be more rigid and not able to conform to the native anatomy 
with clinical reports of kinks forming in the vasculature at the distal end of the device10.  

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In contrast, Open Cell stents, such as the PRECISE® Carotid Stent System (Cordis, Miami, 
FL), are characterized as having fewer connections between adjacent apices and thus having 
larger cell sizes. The benefit of such a design allows for a higher degree of flexibility, which 
conforms to the native anatomy, however the design has less of a scaffolding effect and does 
not cover the plaque as efficiently as do Closed Cell stents.  An additional issue reported is the 
so called “fish-scaling” of the stent struts where when deployed in tortuous anatomy, the stent 
struts come out of alignment and appear as individual scales protruding from the stent11. 
 
As carotid artery stenting devices and techniques continue to evolve, many clinicians have 
described the optimal design.  Consistent with these statements from the podium at scientific 
presentations, Stefan Müller-Hülsbeck describes the ideal carotid stent as having features 
which include “scaffolding that is adequate enough to control plaque prolapse but has 
acceptable levels of flexibility, conformability, and radial strength to track to the lesion, appose 
the vessel wall, and control recoil”.12 
1.3. Study Device Description 
 
GORE® Carotid Stent System 
The GORE® Carotid Stent is designed as a true “hybrid” stent in that it incorporates the 
flexibility and conformability of an Open Cell stent as well as the plaque stabilization of the 
Closed Cell Stent.  Additionally, the device is coated with a covalently bonded Carmeda® 
Bioactive surface heparin to create an anti-thrombogenic surface.  Ease of use of the system 
is designed into the delivery system which not only offers a single-handed deployment handle, 
but allows complete closure of the hemostatic valve to aid in stabilization of the delivery 
system and minimized blood loss. 
 
The GORE® Carotid Stent System consists of a self expanding nitinol stent frame with a 500µ 
pore size lattice on the exterior of the stent frame.  Additionally the stent frame and lattice are 
coated with a permanently bound anti-thrombogenic surface in the form of CBAS® Heparin.  
The stent is mounted on a 5Fr or 6Fr introducer sheath compatible delivery system with a 
working length of 135 cm and a single-handed delivery handle. 
   
The GORE® Carotid Stent, used with the GORE® Embolic Filter, is indicated for the treatment 
of carotid artery stenosis in patients deemed at high surgical risk for CEA.  
x 
Patients with symptomatic carotid artery stenosis, t50%, as confirmed by ultrasound or 
angiography. 
x 
Patients with asymptomatic carotid artery stenosis, t80%, as confirmed by ultrasound or 
angiography. 
x 
Patients must have a Reference Vessel Diameter of 3.7 mm – 9.0 mm. 
 

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1.4. Gore Embolic Protection System 
 
GORE® Embolic Filter 
The GORE® Embolic Filter consists of a device, a delivery catheter, and a retrieval catheter, 
and is compatible with guiding catheters and sheaths having a minimum inner diameter of 
0.066”.  The GORE® Embolic Filter is indicated for general use as a guide wire and embolic 
protection system during angioplasty and stenting procedures in carotid arteries with reference 
vessel diameters of 2.5 to 5.5mm. 
 
2. 
Study Objectives  
2.1. Primary Objective(s) 
The primary objective of this study is to evaluate the safety and efficacy of the GORE® Carotid 
Stent for the treatment of carotid artery stenosis in patients at increased risk for adverse 
events from carotid endarterectomy. 
 
3. 
Study Design 
3.1. Description of Study Design 
This study is a prospective, multicenter, multinational, single-arm clinical study to evaluate the 
safety and efficacy of the GORE® Carotid Stent for the treatment of carotid artery stenosis in 
patients at increased risk for adverse events from carotid endarterectomy.  The primary 
endpoint is a composite of Major Adverse Events through 1 year post-index procedure and will 
be compared to a performance goal developed from published carotid endarterectomy 
outcomes in a high-risk population. 
 

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A maximum of 50 investigative sites in the U.S will participate in this study.  Three hundred 
twelve (312) subjects will be enrolled in this study with a limit of 40 subjects enrolled per site.  
The anticipated accrual rate is approximately 15-20 subjects per month for a total accrual 
period of approximately 18-24 months. 
 
Patients may be enrolled into the clinical study provided all inclusion and no exclusion criteria 
are met. Subjects will be evaluated through hospital discharge and return for follow-up visits at 
30 days, 6 months, and 1, 2, and 3 years post-procedure.   
 
The total study duration from start-up to close-out is expected to be 60 months.  A primary 
endpoint analysis will be submitted to the FDA for PMA approval upon completion of the 1-
year follow-up.   
3.2. Study Endpoints 
3.2.1. 
Definitions 
Stroke:  An acute neurologic event with focal symptoms and signs, lasting for 24 
hours or more. 
 
Minor Stroke: A stroke that resolves completely within 7 days or increases the NIHSS 
by < 4 points. 
 
Major Stroke: A stroke that persists after 7 days and increases the NIHSS by ≥ 4 
points. 
 
Ipsilateral Stroke: A stroke affecting the cerebral hemisphere supplied by the carotid 
artery that is being treated. 
 
Myocardial Infarction:  A troponin level that is twice the upper limit of the normal range 
or higher according to the center’s laboratory, accompanied by either chest 
pain/symptoms consistent with ischemia or ECG evidence of ischemia.   
 

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3.2.2. 
Primary Endpoint  
The primary study endpoint is a composite of Major Adverse Events (MAE) defined as 
death, any stroke, or myocardial infarction (MI) through 30 days post-index 
procedure, and ipsilateral stroke between 31 days and 1 year.  All primary endpoint 
events will be adjudicated and determined by the study Clinical Events Committee. 
. 
3.2.3. 
Secondary Endpoints  
Stent Technical Success:  Successful deployment of a GORE® Carotid Stent 
 
EPD Technical Success:  Technical success for the GORE® Embolic Filter is defined 
as:  Device delivered, placed, and retrieved without requiring assisting interventional 
methods. 
 
Procedure Success: Successful GORE® Carotid Stent deployment, <30% residual 
angiographic stenosis by visual assessment post-procedure in the target lesion and 
no in-hospital (pre-discharge) Major Adverse Event  
 
30-Day Major Adverse Events: Composite of death, any stroke, or myocardial 
infarction through 30 days post-index procedure 
 
In-stent Restenosis: Measured as percent stenosis at follow-up evaluation within the 
stented lesion or within 5 mm proximal or distal to the stent.  Additionally will assess 
percent of subjects with stenosis ≥50% by ultrasound and ≥80% by angiographic 
evaluation 
 
Target Lesion Revascularization (TLR): any clinically driven revascularization 
procedure of the original treatment site, including angioplasty, stenting, 
endarterectomy, or thrombolysis, performed to open or increase the luminal diameter 
inside or within 5 mm of the previously treated lesion.  
 

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4. 
Study Population  
4.1. Description of Population 
The study has been designed with standard eligibility criteria to address any known or 
foreseeable factors that may compromise the outcome of the study or the interpretation of 
results.  
 
The following sections outline the specific inclusion and exclusion criteria for the study 
according to clinical, angiographic, and neurologic components.  Patients who meet all of the 
General Inclusion Criteria, at least one of the High-Risk Inclusion Criteria, and none of the 
General and Angiographic Exclusion Criteria will be eligible for study participation.  All 
potential patients considered for this study should have been diagnosed with carotid stenosis 
and be considered a high perioperative risk for carotid endarterectomy.   
.  
4.2. Inclusion Criteria 
For inclusion in the study, a patient must meet all general inclusion criteria, as shown below: 
General Inclusion Criteria: 
1. Patient is at least 18 years old at informed consent 
2. Patient is willing and capable of complying with all study protocol requirements, including 
specified follow-up period and can be contacted by telephone. 
3. Patient is willing to provide written informed consent prior to enrollment in study. 
4. Patient has no childbearing potential, or is a non-lactating female of childbearing potential 
practicing an acceptable method of birth control with a negative pregnancy test within 10 
days of study procedure. 
5. Patient is either: 
o Symptomatic with carotid stenosis ≥50% as determined by angiography using 
NASCET methodology13.  Symptomatic is defined as amaurosis fugax ipsilateral to 
the carotid lesion; TIA or non-disabling stroke within 180 days of the procedure 
within the hemisphere supplied by the target vessel; or 
o Asymptomatic with carotid stenosis ≥80% as determined by angiography using 
NASCET methodology. 
6. Patient has a target lesion located at the carotid bifurcation and/or proximal ICA. 
7. Patient has a single de novo or restenotic (post CEA) target lesion that can be covered by 
a single 40mm stent. 
8. Patient has a stent landing zone diameter between 3.7 mm and 9.0 mm 
 
 
High Risk Inclusion Criteria: 
For inclusion in the study, a patient must qualify in at least one High-Risk condition, as shown 
below: 
 
 
 

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Anatomic Conditions 
1. Patient has surgically inaccessible lesions at or above the level of C2 or below the 
clavicle. 
2. Patient is status/post radical head or neck surgery or radiation therapy. 
3. Patient has spinal immobility of the neck. 
4. Patient has the presence of tracheostomy stoma.  
5. Patient has laryngeal palsy or laryngectomy. 
6. Patient has contralateral laryngeal nerve paralysis. 
7. Patient has restenosis after a previous CEA. 
 
Co-morbid Conditions 
1. Patient is ≥75 years of age at time of enrollment. 
2. Patient has NYHA Class III or IV congestive heart failure (CHF). 
3. Patient has chronic obstructive pulmonary disease (COPD) with FEV <30%. 
4. Patient has a left ventricular ejection fraction (LVEF) <30%. 
5. Patient has documented uncontrolled diabetes.  
6. Patient has unstable angina with ECG changes. 
7. Patient has had a recent myocardial infarction (≥72 hours, <30 days). 
8. Patient has coronary artery disease with two or more vessels with ≥70% stenosis. 
9. Patient has planned CABG or valve replacement surgery between 31-60 days after the 
CAS procedure. 
10. Patient has contralateral total occlusion of the ICA. 
 
4.3. Exclusion Criteria 
General Exclusion Criteria: 
A patient is not eligible for enrollment in the study if he/she meets any of the following general 
exclusion criteria: 
1. Patient has life expectancy of less than one year. 
2. Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke. 
3. Patient has anticipated or potential sources of emboli (e.g. atrial fibrillation, known 
previously symptomatic patent foramen ovale (PFO), mechanical heart valve, or DVT 
treated within 6 months). 
4. Patient has had an acute myocardial infarction within 72 hours prior to index procedure. 
5. Patient has had any major surgical procedure (i.e. intraabdominal or intrathoracic surgery 
or any surgery/interventional procedure involving cardiac or vascular system) within 30 
days of the index procedure. 
6. Patient plans to have a major surgical procedure (i.e. intraabdominal or intrathoracic 
surgery or any surgery/interventional procedure involving cardiac or vascular system) 
within 30 days after index procedure. 
7. Patient has a history of major, disabling ipsilateral stroke with residual deficit that may 
confound the neurological subject assessments. 

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8. Patient has known severe carotid stenosis contralateral to the target lesion requiring 
treatment within 30 days following the index procedure. 
9. Patient has a modified Rankin Scale of >3 or has another neurological deficit not due to 
stroke that may confound the neurological subject assessments. 
10. Patient has chronic renal insufficiency (serum creatinine ≥2.5 mg/dL). 
11. Patient has platelet count <100,000/μL. 
12. Patient has known sensitivity to heparin or previous incidence of Heparin-Induced 
Thrombocytopenia (HIT) type II. 
13. Patient has contraindication to standard of care study medications, including antiplatelet 
therapy. 
14. Patient has known sensitivity to contrast media that cannot be adequately controlled with 
pre-medication. 
15. Patient has known bleeding diathesis or hypercoagulable state or refuses blood 
transfusions. 
16. Patient has intracranial pathology that, in the opinion of the investigator, makes the patient 
inappropriate for study participation (e.g. brain tumor, AVM, cerebral aneurysm, etc) or 
would confound neurological evaluation. 
17. Patient had intracranial hemorrhage within the last 90 days. 
18. Patient is contraindicated for the GORE® Embolic Filter per the criteria outlined in the IFU. 
19. Patient is currently enrolled in another investigational study protocol and has not 
completed its primary endpoint or that will confound the current study endpoints.  Patients 
who are involved in the long-term surveillance of a clinical study are eligible. 
 
Angiographic Exclusion Criteria: 
A patient is not eligible for enrollment in the study if he/she meets any of the following 
angiographic exclusion criteria: 
 
1. Patient has a total occlusion of the target carotid arteries (i.e., CCA or ICA). 
2. Patient has a previously placed arterial stent distal to or including the origin of the 
ipsilateral great vessel (includes a stent anywhere in the ICA, CCA or brachiocephalic 
artery).  
3. Patient has severe lesion calcification that may restrict the full deployment of the carotid 
stent. 
4. Patient has the presence of filling defect or thrombus in target vessel. 
5. Patient has occlusion or presence of “string sign” of the target vessel. 
6. Patient has carotid (intracranial) stenosis located distal to target stenosis that is more 
severe than target stenosis. 
7. Patient has ≥50% stenosis of the CCA proximal to the target lesion. 
8. Patient has known mobile plaque,thrombus, or excessive calcification in the aortic arch. 
9. Patient has aneurysmal carotid bifurcation on the ipsilateral side. 
10. Patient has tortuous anatomy or disease morphology which would prohibit the safe 
placement of guide catheter, sheaths, embolic protection systems or stent systems within 
the access or target vessel. 

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5. 
Study Procedures/Evaluations  
5.1. Study Procedures and Evaluation Schema 
No GORE® Carotid Stent Attempt
(Patient Not Enrolled)
GORE® Carotid Stent Attempted
(Patient Enrolled as Study Subject)
Follow-up:
Post Procedure (Pre Discharge)
30 days, 6, 12, 24, 36 months
(calculated from procedure)
- Physical Exam
- NIHSS / Modified Rankin
- CDUS (30d, 6m,1y, 2y,3y)
- Adverse Events
- Medications
Continue F/U until completion or 
discontinuation
Eligibility Screening and Consent
Evaluate patient eligibility
Obtain informed consent
Obtain review by Screening Committee
Baseline Evaluations:
- Demographics/Medical History
- Physical Exam
- NIHSS / Modified Rankin
- Lab Evaluations
- Ultrasound Evaluation
- MRI/CT for symptomatic patients
Patient is Screen Failure
- Complete Subject Screening Log
- No CRF Completion Required
No Additional F/U required
Includes subjects who have:
- Alternative stent implant
- No stent implant
Follow-up:
30 days (calculated from 
procedure)
Complete CRF Intervals:
- Screening 
- Eligibility and Enrollment 
- Procedure
- Subject F/U – 30 Days
- Completion/Discontinuation
UNSUCCESSFUL
GORE® Carotid Stent
Implant
SUCCESSFUL
GORE® Carotid Stent
Implant
 

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5.2. Schedule of Events 
The table below presents the procedures and evaluations for each protocol interval. 
 
 
Procedure or Evaluation 
Screening 
Pre-procedure 
Procedure/ 
Enrollment 
Post-Procedure 
(prior to hospital 
discharge) 
30 days 
(r7 days) 
6 months 
(r14 days) 
1 Year 
(r30 days) 
2 & 3 Years 
(r45 days) 
Unscheduled 
Early Withdrawal 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
Demographics & 
Medical History 
X 
 
 
 
 
 
 
 
 
 
Exam & Vital Signs7 
X6 
 
X 
X 
X 
X 
X 
X5 
X 
NIH Stroke Scale1 
 
X 
 
X 
X 
X 
X 
X 
X5 
X 
Modified Rankin Scale6 
X 
 
 
X 
X 
X 
X 
X5 
X 
CT Scan or MRI 
X2 
 
 
 
 
 
 
  
 
 
Carotid Duplex Ultrasound 
X3 
 
 
 
X 
X 
X 
X 
X5 
X 
Cerebral Angiography 
 
 
X 
 
 
 
 
 
X5 
 
Screening angiogram or CTA 
X 
 
 
 
 
 
 
 
 
Screening Committee review 
X 
 
 
 
 
 
 
 
 
12-lead ECG6 
X 
 
X 
 
 
 
 
X5 
 
Chemistry6 
(BUN, Creatinine) 
X 
 
 
 
 
 
 
X5 
 
Hematology6 
(CBC with Platelets) 
X 
 
X 
 
 
 
 
X5 
 
Cardiac Enzymes 
(Troponin) 
 
X 
 
X 
 
 
 
 
X5 
 
Pregnancy Test4 
 
X 
 
 
 
 
 
 
 
 
Assess Concomitant 
Medications(antiplatelet or 
anticoagulant therapy) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Assess Adverse Events 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
1 
Neurological assessments by a physician certified in the administration of NIHSS or research personnel certified in the administration 
of NIHSS 
2 
Required for symptomatic patients only within 180 days prior to index procedure 
3 
Obtained within the 60 days preceding the index procedure 
4 
Obtained within the 10 days preceding the index procedure. Pregnancy test (via urine or blood) required for females of childbearing 
potential 
5 
To be done when clinically indicated 

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6 
May be obtained at either screening or pre-procedure visit 
7 
Vital Signs include: Blood Pressure, Pulse, and respirations. Collection of height and weight will be done at screening.  Temperature 
should be collected pre- and post- procedure at a minimum 
 
5.3. Informed Consent Process 
All patients must provide written informed consent prior to submission of pre-procedure 
imaging and medical history to the Screening Committee for review (refer to Section 5.5 for 
details) and prior to any study related procedures being performed.  The case history (i.e. 
source documents/subject chart) for each subject shall document that such informed consent 
was obtained.  The IRB approved consent form will be signed and personally dated by the 
subject, and the person who conducted the informed consent discussion.  The original signed 
informed consent form will be retained in the subject records.  A copy of the informed consent 
document will be given to the subject for their records.    
 
5.4. General Study Evaluation Guidelines 
For the purposes of the study the following are required: 
 
National Institutes of Health Stroke Scale (NIHSS) may only be performed by an individual 
certified to perform the NIHSS even if others may be qualified per state or local regulation.  
Any potential endpoint neurological symptoms will be assessed by the NIHSS.  All NIHSS 
certifications must be kept up to date. 
 
Electrocardiograms (ECG) will not be sent to a core lab and should be reviewed per site’s 
standard processes. 
 
Screening and follow-up carotid duplex ultrasounds will be sent to the ultrasound core lab.  
Any unscheduled ultrasounds performed due to an Adverse Event will also be sent to the core 
lab. Please refer to section 6.4 for details.   
 
All applicable angiograms as well as any re-intervention angiograms will be sent to the 
Angiographic core lab.  Please refer to sections 5.7 and 6.4 for details.   
 
Other tasks may be performed by those individuals who are qualified by training and who have 
been designated by the site’s Principle Investigator to perform those tasks 
5.5. Pre-Screening/Screening 
All patients who sign an ICF will be considered entered into the screening phase of the study. 
A subject screening log will be maintained at each site to document select information about 
the patients who sign informed consent.  For patients who did not meet eligibility criteria after 
signing informed consent, the reasons for exclusion will be documented on the subject 
screening log.  
The following evaluations will be conducted at the screening visit or must have been 
completed no more than 30 days prior to enrollment (except as noted): 
x 
Informed consent (prior to any study related procedures being performed) 

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x 
Inclusion and exclusion criteria assessed; confirmation is required by Screening 
Committee  
x 
Assess medical history, demographics, and concomitant medications 
x 
Modified Rankin Scale 
x 
12-lead ECG  
x 
Examination and vital signs 
x 
Chemistry (BUN & Creatinine)   
x 
Hematology (CBC including platelets) 
x 
Bilateral Carotid Duplex Ultrasound (within the 60 days preceding the index procedure)  
x 
Angiography (within 30 days) and/or CTA (within 60 days) 
x 
CT or MRI Brain Imaging for symptomatic patients only (Within 180 days of the index 
procedure)I 
 
Pre-screening Assessment 
A Screening Committee will review pre-operative angiography and/or CTA, along with patient 
medical history, for assessment of entry criteria, and approval prior to the study procedure.    
The Screening Committee will be comprised of an interdisciplinary team of study investigators 
with pertinent knowledge in carotid stenting. The members will not review potential cases from 
their own sites. The members will be compensated for their involvement in the Screening 
Committee, including reimbursement for reasonable travel expenses to attend meetings.   
 
This committee will operate under pre-specified procedures as outlined in the Screening 
Committee Charter.    
 
Prior to a patient being enrolled in the study, the investigational site must receive confirmation 
from the Screening Committee that the subject is eligible to be enrolled.  Although patient may 
be deemed eligible to be enrolled, it is still the responsibility of the investigator to assess all 
inclusion and exclusion criteria prior to enrollment. 
 
Screening Angiogram and/or CTA 
In addition to review of medical history, patients will be screened by the Screening Committee 
based on the results of an angiogram or CTA.  These images must include at a minimum the 
aortic arch, ipsilateral carotid artery (origin and bifurcation), target lesion and intracranial and 
extracranial views.  A complete diagnostic study will be needed in order to evaluate fully the 
patient against entry criteria.  Submission of complete case images is strongly encouraged.  
 
Carotid Duplex Ultrasound 
Patients will be screened using a bilateral carotid duplex ultrasound within 60 days of 
enrollment to verify that baseline percent stenosis values are consistent with entry criteria and 
justify proceeding with angiography and stent placement.   
 
The diagnostic angiography results prior to the stenting procedure will be the definitive 
measure of compliance with vessel stenosis criteria. 

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If a bilateral carotid duplex ultrasound was completed prior to the patient’s consent to 
participate in the clinical trial but is within 60 days preceding the study procedure, the results 
may be used in lieu of repeating the ultrasound for the clinical trial.   
 
MRI / CT for Symptomatic Patients 
CT or MRI brain imaging is required for symptomatic patients in order to rule out non-carotid 
pathology.  Additional assessment of the carotid arteries and the morphology of the aortic arch 
may be achieved through CTA or MRA but the results of these studies may not be used as a 
substitute for a carotid ultrasound or carotid angiography.  If CT or MRI brain imaging was 
completed at the time of the “symptomatic” event (within 180 days) and is prior to the patient’s 
informed consent to participate in the clinical trial, the CT or MRI results obtained following that 
event may be used in lieu of repeating the imaging for the clinical trial.   
 
5.6. Pre-Procedure Assessments 
The following must be completed within 24 hours preceding the index procedure: 
x 
Exam and vital signs (if not done at screening) 
x 
NIHSS 
x 
Modified Rankin Scale (if not done at screening) 
x 
12-lead ECG (if not done at screening) 
x 
Baseline Cardiac Enzyme -Troponin (may be obtained once arterial access is gained but 
not after any interventional wires enter the subject’s vasculature) 
x 
Pregnancy test if applicable (within the 10 days preceding the index procedure) 
x 
Blood work not completed at screening visit 
Concomitant medications (antiplatelet or anticoagulant therapy) 
Pre Procedure Antiplatelet Therapy 
Preparation of patients receiving the GORE® Carotid Stent should include initiation of an 
appropriate dosage of oral antiplatelet medication prior to and following the procedure. 
Effective anticoagulation therapy should be maintained throughout the procedure and 
continued into the postoperative period as deemed appropriate by the treating physician.  
 
Prior to the index procedure, patients must be on a form of antiplatelet therapy. Patients who 
are on antiplatelet therapy prior to consenting for the trial may continue their current regimen.  
However, if a patient is not on any antiplatelet regimen, the following dosages are 
recommended: 
 
x 
Aspirin 75-325 mg by mouth beginning 3 days prior to procedure  
x 
Clopidogrel 75 mg by mouth beginning 3 days prior to procedure  
 
If the above is not possible the following may be administered 4-6 hours prior to procedure: 
 
x 
Aspirin 325 mg by mouth  

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x 
Clopidogrel 75-600 mg by mouth (in accordance with local standard of practice) 
 
5.7. Procedure 
The following will be collected during the procedure and enrollment time points: 
x 
Cerebral angiography to confirm Angiographic entry criteria 
x 
Concomitant medications (antiplatelet or anticoagulant therapy) 
x 
Adverse events assessment 
 
Only physicians who have received appropriate training and are familiar with the principles, 
clinical applications, complications, side effects and hazards commonly associated with carotid 
interventional procedures should use this device. 
 
The index procedure begins at time of vascular access and is considered completed at the 
time of vascular closure, sheath removal, or when all wires, catheters and devices are 
removed and the sheath is secured for removal outside the cath lab; whichever comes first.  
This information will be collected on the procedure case report form.   
 
The procedure is performed under local anesthesia with minimal sedation to facilitate 
continuous neurological evaluation.  The need for continuous monitoring of the subject’s 
baseline level of awareness during the procedure, with techniques that can consist of a rubber 
squeeze toy or verbal verification, should be utilized and explained to the subject.  If it is 
believed that a neurological status change has occurred, the NIHSS will be repeated. 
 
An initial arch and carotid angiogram must be performed prior to cannulation of the arch 
vessels or the carotid artery.  Cerebral angiograms (extracranial and intracranial images) must 
also be completed showing the tip of the catheter, or other form of calibration, and the carotid 
bifurcation.  This complete diagnostic study is required to fully evaluate the subject against 
angiographic exclusion criteria.  If subjects have undergone the above diagnostic imaging 
within 30 days preceding the index procedure, these films may be substituted for performance 
of repeat diagnostic angiography.  These films must be made available to the investigator prior 
to the procedure and be submitted to the angiographic core lab per their specifications 
following the index procedure. 
 
Once it is determined that the subject meets all entry requirements for the study, systemic 
anticoagulation should be given.  Administer heparin (bivalirudin may be substituted in local 
regions where approved) to achieve and maintain an activated clotting time (ACT) of t 250 
seconds prior to deployment of the embolic protection device.  Periodic testing of the ACT 
level should be done to ensure that the ACT level is maintained during the intervention. The 
use of IIb/IIIa inhibitors is prohibited during the procedure. 
 
 
5.8. Enrollment   

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The patient will be considered enrolled in the study when the investigational device enters the 
patient’s vasculature.  All patients enrolled in the study should be followed until completion of 
the study, or withdrawal from study follow-up. 
 
If the decision is made not to attempt the GORE® Carotid Stent and therefore not enroll the 
patient, the patient will be considered a screen failure and the status and reason for not 
enrolling noted on the subject screening log. 
 
A patient may only be enrolled into the study once.  A patient with carotid artery disease 
contralateral to the target lesion in which both sides require treatment may be enrolled into the 
study; however, only one side may be treated at the index procedure.   
 
Embolic Protection System 
The investigator must select the GORE® Embolic Filter for embolic protection during the 
procedure and should pay specific attention to the device IFU for specific patient selection 
criteria.       
  
After an unsuccessful documented attempt with the GORE® Embolic Filter, an alternative 
locally approved embolic protection device may be used to complete the procedure.  
 
Unprotected pre-dilation is strongly discouraged.  Embolic protection with the GORE® Embolic 
Filter should be in place prior to stenting.  
 
GORE® Carotid Stent 
Selection of the correct size GORE® Carotid Stent should be done using the sizing 
instructions in the table below and/or the IFU for the device.  Oversizing of the stent to the 
vessel diameter is not recommended.     

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GORE® Carotid 
Stent Part Number 
Unconstrained 
Stent Dimensions 
Reference Vessel 
Diameter 
Minimum Introducer or 
Guiding Sheath Catheter I.D.
5F 
GCS5530 
5 x 30 mm 
3.7-4.5 mm 
074” (1.88 mm) 
GCS5540 
5 x 40 mm 
GCS6630 
6 x 30 mm 
4.5-5.4 mm 
GCS6640 
6 x 40 mm 
GCS7730 
7 x 30 mm 
5.4-6.3 mm 
GCS7740 
7 x 40 mm 
GCS8830 
8 x 30 mm 
6.3-7.2 mm 
GCS8840 
8 x 40 mm 
GCS6830 
6-8 x 30 mm taper 
4.5-5.4 mm x 6.3-7.2 mm 
GCS6840 
6-8 x 40 mm taper 
 
6F 
GCS9930 
9 x 30 mm 
7.2-8.1 mm 
080” (2.03 mm) 
GCS9940 
9 x 40 mm 
GCS0030 
10 x 30 mm 
8.1-9.0 mm 
GCS0040 
10 x 40 mm 
GCS7930 
7-9 x 30 mm taper 
5.4-6.3 mm x 7.2-8.1 mm 
GCS7940 
7-9 x 40 mm taper 
GCS8030 
8-10 x 30 mm taper 
6.3-7.2 mm x 8.1-9.0 mm 
GCS8040 
8-10 x 40 mm taper 
 
Post-procedural extracranial and intracranial angiograms should be performed in accordance 
with the angiographic core laboratory specifications. 
 
GORE® Carotid Stent Technical Failure 
If a GORE® Carotid Stent is not implanted due to technical reasons, another locally approved 
carotid stent may be used to complete the procedure.  Subjects who do not have a successful 
GORE® Carotid Stent implant during the index procedure will be considered technical failures.  
Technical failure subjects only require follow-up through 30 days post-procedure and will then 
have completed the study. 
 
Device failures and malfunctions will be documented on the Stent Assessment case report 
form and the study device will be returned to W. L. Gore and Associates, Inc. for analysis.  
Instructions for returning the study device will be provided in the study binder supplied by W. L. 
Gore and Associates, Inc.   
 
Examples of when to return device malfunctions include (but are not limited to): 
x 
Device fails to perform as intended 
x 
Device physically deforms or breaks, even if due to user error 
x 
Packaging is defective 
 
Any opened but unused device will need to be returned to W. L. Gore and Associates, Inc.   
 

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5.9. Repeat Interventions 
Any clinically driven revascularization procedure of the original treatment site, including 
angioplasty, stenting, endarterectomy, or thrombolysis performed to open or increase the 
luminal diameter inside, or within 5 mm, of the previously treated lesion may be performed.   
 
Only devices or therapies that are commercially available at the time of the revascularization 
may be used.  All angiograms in relation to the re-intervention must be sent to the 
Angiographic core lab.  Please refer to section 6.4. 
5.10. Post-Procedure 
The following will be completed between 4-48 hours post procedure or prior to discharge, 
whichever comes first (unless otherwise indicated): 
x 
Exam and vital signs 
x 
NIHSS 
x 
12-lead ECG 
x 
Hematology blood work (CBC including platelets) 
x 
Cardiac Enzymes (Troponin) – to be completed within 8-16 hours post-procedure.  If the 
subject experiences cardiac related chest pain lasting longer than 15 minutes, a change in 
baseline ECG, or the value has increased to 2 (two) times the upper limit of normal, serial 
cardiac enzymes will also be completed at 18-24 hours post procedure.   
x 
Adverse events assessment 
x 
Concomitant medications (antiplatelet or anticoagulant therapy) assessment 
 
Post Procedure Antiplatelet Therapy 
Subjects will receive post-procedure antiplatelet medication per the institution’s standard of 
care, or using the following recommended regimen: 
x 
Aspirin 75-325 mg by mouth once a day for the duration of the study 
x 
Clopidogrel 75 mg by mouth once a day for 30 days; then per physician discretion 
 
5.11. Follow-Up 
Subjects with successful GORE® Carotid Stent implant will return for follow-up at 30 days, 6 
months, 1, 2 and 3 years.  Subjects considered Technical Failures (no GORE® Carotid Stent 
implant) are only required to complete a 30 day follow-up and will have then completed the 
study. 
 
The following assessments are required for each follow-up visit (unless indicated otherwise): 
x 
Exam and vital signs 
x 
NIHSS 
x 
Modified Rankin Scale 
x 
Carotid Duplex Ultrasound of target vessel  
x 
Concomitant medications (antiplatelet or anticoagulant therapy) assessment 
x 
Adverse events assessment 

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Follow-up Visit Windows 
The follow-up visits should be completed within an acceptable time frame and in accordance 
with the protocol defined visit windows.  All intervals are to be calculated from the index 
procedure.  The 6-Month visit target is 180 days.  The yearly visits are calculated on a 
calendar year from index procedure. 
 
30 Days 
6 Months 
(180 Days) 
1 Year 
2 & 3 Years 
r 7 days 
r 14 days 
r 30 days 
r 45 days 
 
If the visit is not able to be completed during these windows the visit should be completed as 
soon as possible; however, it will be considered a protocol deviation and should be reported 
per local IRB policy. 
 
5.12. Subject Withdrawal from the Clinical Study 
A subject may withdraw from the clinical study at any time and should notify the Investigator in 
this event.  The Investigator may also withdraw the subject from the clinical study at any time 
based on his/her medical judgment.  The Investigator will encourage subjects to return for all 
required follow-up visits.   
 
All subjects who withdraw from the study should complete an end of study visit.  No further 
visits are required by the subject once the end of study visit is complete. 
 
5.13. Subject Lost to Follow-Up 
The Investigator should encourage subjects to return for the required follow-up visits.  These 
measures are important as the clinical study objectives may not be realized if a large number 
of subjects are lost to follow-up (LTF).   
 
A subject may withdraw from the clinical study at any time and should notify the Investigator in 
this event.  If a subject refuses to return for the follow-up visits, the Investigator will attempt to 
obtain at least vital status and whether or not the subject has experienced a stroke or TIA.  In 
the event of subject death, a death certificate or autopsy report should be obtained to confirm 
cause of death and reported on the Subject Completion / Discontinuation Form. 
 
A subject will be considered LTF and discontinued from the study once they have missed two 
required follow-up visits and three documented attempts for each pending study related visit 
have been made by the Investigator to contact the subject.   
 
One of the three documented attempts must include a certified (traceable) letter.  The 
Investigator must complete the appropriate CRF (CRF Study Completion / Discontinuation 
Form) documenting the subject’s withdrawal or discontinuation from the clinical study.  The 
subject will be considered withdrawn once the Sponsor receives the respective CRFs. 

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The Investigator may also withdraw the subject from the clinical study at any time based on 
the Investigator’s medical judgment.   
 
The study Monitor will ensure that subject withdrawals are documented properly, discussed 
with the Investigator, and reported to the Sponsor  
 
5.14. Subject Study Completion 
A subject has completed the study when he/she has completed the 3-year follow-up 
evaluations.   Any subject that does not complete these requirements due to voluntary 
withdrawal, physician withdrawal, death, or any other reason will be considered as an early 
withdrawal. In the event of a Technical Failure (no GORE® Carotid Stent implanted), the 
subject will be followed through the 30-day visit and will be considered to have completed the 
study. 
5.15. Explant Procedures 
The GORE® Carotid Stent may be explanted during a surgical procedure or as part of an 
autopsy. Sites are requested to return explanted device to the Sponsor for gross and 
histological evaluation. Prior to planned or potential device retrieval, contact the Gore 
associate managing the study to communicate that a specimen is being retrieved from a study 
subject. A specimen shipping kit will be immediately sent to the Site. The specimen kit 
provides specific packaging and handling instructions for the specimen and contains a 
shipping container. 
 
6. 
Clinical Study Administration  
6.1. Device Training 
Physician device training will be provided by a qualified Gore Associate.  The minimum 
requirements for physician device training include:   
1. Didactic training for each investigator at site 
2. First case for each investigator is supported by a qualified Gore Associate. 
6.2. Monitoring 
Site monitoring for this study will be provided by:  
 
 
 
       
 
       
 
 
 
 
 
The Site monitors are qualified by training and experience to oversee the progress of the study 
at the Site and will ensure that the Investigators and their staff understand and adhere to both 
the applicable regulatory requirements and the study protocol.  In addition, they may assist in 
resolution of any problems that may arise during the study. 
 

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Site Initiation  
Site initiation will be performed to ensure that each Investigator and his/her staff understands 
the protocol, applicable regulations, human subject protection requirements, and the 
Investigator’s obligations.  This visit will ensure that required documentation with the 
appropriate approval is in place prior to subject enrollment. 
 
Training on the study EDC System and data gathering requirements may also be done at this 
time.    
 
Periodic Site Monitoring  
Periodic Site monitoring will occur as necessary to ensure continuing adequacy of facilities 
and adherence to the clinical study protocol, GCP, and applicable regulations and laws that 
pertain to the conduct of the clinical study.  These activities will also review the CRFs and 
source documentation, the timely submission of accurate records to the Sponsor, and the 
maintenance of proper records.  A report will be written following each Site visit and a follow 
up letter will be provided to the Site with a summary of findings.   
 
6.3. Device Accountability and Storage  
The GORE® Carotid Stent may only be used under the supervision of the Investigator and in 
strict accordance with this protocol and applicable laws and regulations. The device may only 
be implanted in subjects who meet the inclusion/exclusion criteria set forth in this protocol and 
used only as described in this protocol. The Investigator will maintain accurate, detailed 
records of all devices received from the Sponsor and the disposition of each device.  The 
Investigator will record each device used on the corresponding CRF.  The Investigator will 
notify the Sponsor immediately if any devices are damaged or unaccounted for. The devices 
must be accessible only to the personnel involved in the study and stored in a secure location.  
 
Upon completion or termination of the clinical study or the Investigator’s participation in the 
clinical study, or at the Sponsor’s request, the Investigator will return any remaining supply of 
the device to the Sponsor. 
6.4. Core Labs 
Core Lab services for this study will be provided by: 
 
 
 
       
 
       
 
      
             
 
                                    
 

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Please refer to the Imaging Guidelines for each specific core lab for instructions on submission 
of images and specific requirements for the images. 
 
6.5. Protocol Deviations 
A Protocol Deviation is defined as any change, divergence, or departure from the study design 
or procedures of a research protocol.t The Investigator is responsible for promptly reporting 
Protocol Deviations to their reviewing IRB per IRB policy and the Sponsor. The Sponsor will 
determine the effect of the protocol deviation on the scientific soundness of the clinical study 
and subject safety and determine if additional reports or actions are required. Additional action 
may include Site retraining, removal of devices from the Site, and/or Site termination.    
 
The Investigator will not implement any changes to the protocol without first obtaining written 
agreement from the Sponsor and documented approval from the IRB, except in the event of 
an immediate hazard(s) to a subject.  The Investigator will report the deviation in accordance 
with the applicable regulations.         
6.6. Protocol Amendments 
The Investigator will obtain IRB approval on all amendments in a timely manner. The Sponsor 
will ensure proper training of Investigator and Site staff on all protocol amendments. 
 
6.7. Sponsor Representatives 
Sponsor representatives may be present during study procedures to provide technical 
assistance to the Investigator in the use of the device.  The activities of these Sponsor 
representatives will be supervised by the Investigator.  
 

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6.8. Access to Source Data/Documents 
Source data are defined as all information necessary for the reconstruction and evaluation of 
the clinical investigation.  
 
The Investigator will keep all study records, source data and investigational devices available 
for inspection by the Sponsor, Sponsor’s monitors, IRB, and regulatory authorities. 
 
6.9. Study Records Retention  
The Investigator will maintain complete, accurate and current study records as required by 
applicable regulatory requirements.  Records will be maintained during the clinical study and 
for a minimum of two years after the latter of the date on which the study is terminated or 
completed, or the date the records are no longer required to support regulatory approval of the 
device. In any event, clinical study records will not be disposed of, nor custody of the records 
transferred, without prior written Sponsor approval.    
Investigator records will include, but not be limited to:  
x 
All correspondence with another investigator, an IRB, the Sponsor, a monitor, or 
Regulatory Authority, including required reports. 
x 
Records of receipt, use or disposition of a device that relate to: 
o The type and quantity of device(s) received, the date(s) of its receipt, and lot or 
batch number or code mark. 
o The names of all persons who received, used, or disposed of each device. 
x 
Records of each subject’s case history and exposure to the device.  Case histories 
include the case report forms and supporting data including, for example, signed and 
dated consent forms and medical records, including, for example, progress notes of the 
physician, the  individual’s hospital chart(s), and the nurses’ notes.  Such records shall 
include: 
o Documents evidencing informed consent and, for any use of a device without 
informed consent, any written concurrence of a licensed physician and a brief 
description of the circumstances justifying the failure to obtain the informed 
consent.  The case history for each individual shall document that informed 
consent was obtained prior to participation in the study.   
o All relevant observations, including records concerning adverse device effects 
(anticipated and unanticipated), the information and date and condition of each 
subject upon entering, and information about relevant previous medical history and 
the results of all diagnostic tests; 
o A record of the exposure of each subject to the investigational device, including 
the date and time of each use, and any other therapy. 
x 
The protocol, any amendments, and documentation of any deviations from the protocol, 
including the dates and the reasons for such deviations. 
x 
Any other records that Regulatory Authority requires to be maintained by regulation or by 
specific requirement for a category of investigations or a particular investigation. 
x 
A certification stating that the US IRB is in compliance with FDA regulations 
x 
A signed Investigator Agreement. 
x 
Any other records as required by the Regulatory Authority, the IRB and the Sponsor. 

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The Investigator will prepare and submit the following reports:  
x 
Withdrawal of IRB approval: The Investigator will report any withdrawal of approval within 
5 working days after the Investigator has been notified of the withdrawal. 
x 
Progress reports: Progress reports documenting the procedure, AEs and follow-up data 
concerning individual subjects will be submitted to the Sponsor on standardized CRFs.  
The Investigator may also be required to submit progress reports and final reports to the 
IRB and to the Sponsor summarizing the Investigator’s experience during the study.  
x 
UADE Reports: UADEs shall be reported as described in Section 9. 
x 
Protocol Deviations shall be reported as described in Section 6. 
x 
Other: Any other reports as reasonably requested by the Sponsor or required by 
Regulatory Authority. 
 
7. 
Data Collection and Submission 
The Clinical Data Management System (CDMS) for this study will be provided by: 
 
 
 
7.1. Data Collection Methods  
This study will report clinical data using the 
 CDMS web-based application. 
The CDMS will be the database of record for the protocol and subject to regulatory 
inspections. All users will be trained to use the CDMS and will comply with study specific 
guidelines/instructions as well as applicable regulatory requirements. 
 
Subject data will be collected using protocol-specific electronic case report forms (eCRF).  The 
approved annotated case report forms will be used to create the electronic screens in the 
CDMS application. Site staff will enter data into the eCRF for transmission to the Sponsor. The 
Sites will be notified of any amendments to the eCRFs. 
 
7.2. Data Clarification and Correction  
All eCRFs will be evaluated upon receipt by the Sponsor. Corrections to missing, incomplete 
or inconsistent data will be requested from the Site personnel and made though the CDMS.  
The changes, reason for changes, and person making the change will be documented in the 
CDMS. 
 
7.3. CRF Completion Schedule 
All CRFs should be completed within 14 days of each visit.   
 
 

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8. 
Risk Assessment  
8.1. Potential Risks  
The risks associated with the GORE® Carotid Stent for use in carotid arteries are expected to 
be similar to the risks associated with the use of other commercially available standard of care 
devices. 
 
Such risks associated with these devices, including the GORE® Carotid Stent include, but are 
not limited to:  
 
x 
Deployment and retrieval failure 
x 
Detachment and / or implantation of a component of the system 
x 
Stent deformation 
x 
Stent embolization 
x 
Stent / filter entanglement / damage / dislodgement 
x 
Stent malposition 
x 
Stent migration 
x 
Stent thrombosis / occlusion 
 
Risks associated with these devices including the GORE® Carotid Stent or the interventional 
procedures include, but are not limited to:  
 
x 
Allergic reactions to anti-platelet agents / contrast medium 
x 
Aneurysm 
x 
Angina / coronary ischemia 
x 
Arrhythmia 
x 
Arterial occlusion / thrombosis at puncture site or remote site 
x 
Arteriovenous fistula 
x 
Bacteremia or septicemia 
x 
Balloon burst or rupture 
x 
Balloon associated thrombosis 
x 
Bleeding from anticoagulant or antiplatelet medications 
x 
Bradycardia / arrhythmia and other conduction disturbances 
x 
Cerebral edema 
x 
Cerebral hemorrhage 
x 
Cerebral ischemia / transient ischemic attack (TIA) 
x 
Congestive heart failure 
x 
Death 
x 
Drug reactions 
x 
Emboli, distal (air, tissue or thrombotic emboli) 

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x 
Emergent or urgent endarterectomy surgery (CEA) 
x 
Fever 
x 
Filter fracture 
x 
Filter thrombosis / occlusion 
x 
Fluid overload 
x 
Groin hematoma, with or without surgical repair 
x 
Headache  
x 
Hemorrhage, with or without transfusion 
x 
Hemorrhagic stroke 
x 
Heparin induced thrombocytopenia (HIT) 
x 
Hyperperfusion syndrome 
x 
Hypotension / hypertension 
x 
Infection and pain at insertion site 
x 
Ischemia / infarction of tissue / organ 
x 
Ischemic stroke 
x 
Myocardial infarction (MI) 
x 
Pain and tenderness 
x 
Pseudoaneurysm, femoral 
x 
Reduced blood flow 
x 
Renal failure / insufficiency 
x 
Restenosis of stented segment 
x 
Seizure 
x 
Sepsis 
x 
Severe unilateral headache 
x 
Stroke / cerebrovascular accident (CVA) or other neurological complications (e.g., 
paralysis, paraplegia or aphasia) 
x 
Surgery required due to device failure 
x 
Temporary or total occlusion of carotid artery 
x 
Thromboembolic episodes 
x 
Thrombophlebitis 
x 
Transient ischemic attacks (TIA) 
x 
Vascular access complications (e.g., bleeding, vessel damage, pseudoaneurysm and 
infection) 
x 
Ventricular fibrillation 
x 
Vessel dissection, perforation, or rupture 
x 
Vessel spasm or recoil 
x 
Vessel thrombosis (partial blockage) 
x 
Unstable angina pectoris 

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8.2. Minimization of Risks 
Potential risks associated with the use of the GORE® Carotid Stent may be minimized by the 
following activities: 
 
x 
The Sponsor has performed qualification testing on the device and device components 
and appropriate quality control measures have been implemented into production.   
 
x 
Investigators will be selected who are knowledgeable and experienced in carotid artery 
stenting procedures. 
 
x 
Comprehensive Site Investigator and staff training will be conducted to share information 
regarding design and proper use of the GORE® Carotid Stent.    
 
x 
The Site Investigator, Sub-Investigators, Clinical Study Coordinator(s) or designee at each 
Site will be trained to the protocol and Subject follow-up requirements.  
 
x 
Protocol inclusion/exclusion criteria and follow-up schedules are designed to select 
appropriate subjects and identify potential complications early. 
 
x 
Subjects will be assessed post-procedure and subsequently on a regular basis to collect 
information on the subject’s status and any reportable adverse events. 
 
x 
Data completed by the Sites will be monitored to evaluate protocol compliance and the 
data for accuracy and subject safety. 
 
x 
Safety and efficacy data obtained during the clinical study will be shared with the Site 
Investigators to aid understanding of the device and potential complications associated 
with its use. 
8.3. Summary of Expected Benefits 
The GORE® Carotid Stent is expected to be safe and effective when used to treat stenosis of 
the carotid artery.  The intent is to increase blood flow to the brain while decreasing the 
narrowing in the artery, and to help prevent future strokes. 

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9. 
Adverse Events and Safety Monitoring  
Adverse Events (AEs) are defined as any untoward medical occurrences in a subject whether 
device-related or not.   
9.1. Anticipated Adverse Events  
Anticipated Adverse Events are complications that are known to be associated with carotid 
artery stenting.  Potential complications of carotid artery stenting are listed in Section 8 above.  
If a complication occurs that is not on the list of known, potential complications and the 
investigator believes that the complication is a potential UADE (Unanticipated Adverse Device 
Effects, see section below), the site should immediately contact the Sponsor to determine 
reporting requirements. 
 
Anticipated Adverse Events are complications that are known to be associated with carotid 
artery stenosis patients undergoing an angioplasty and stenting procedure.  See Section 8, 
Risk Assessment.  
9.1.1. 
Adverse Event Relationship 
Each reported AE will be assessed by the Investigator for its primary suspected 
relationship to the carotid stent, embolic protection device, procedure, medication, or 
disease.  Only one primary relationship will be assigned to each reported AE. 
 
Study Device-related  
The functioning or characteristics of the device caused or contributed to the Adverse 
Event. 
 
Embolic Protection System (EPD)-related  
The functioning or characteristics of the EPD caused or contributed  to the Adverse 
Event.   
 
Study Procedure-related  
The study index procedure (and not the device or EPD) caused or significantly 
contributed to the Adverse Event. 
 
Medication-related   
The Adverse Event was a result of medical therapy prescribed by the study protocol 
and not the device, EPD, or procedure.   
 
Disease-related   
The Adverse Event was a result of the underlying disease progression for which the 
study procedure is being performed, and not the device, EPD or procedure. 
   
 
 
 

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Not related  
An Adverse Event which cannot be attributed to the device, EPD, procedure, 
medication or disease.   
 
Unknown relationship  
The relationship of the Adverse Event to the device, EPD, procedure, medication or 
disease cannot be determined. 
 
9.1.2. 
Adverse Event Classification 
Each AE will be assessed by the Investigator to determine if it is a Serious Adverse 
Event as defined below: 
 
Serious Adverse Event  
A Serious Adverse Event is an adverse event that 
x led to death 
x led to serious deterioration in the health of the subject that either resulted in 
o a life threatening illness or injury, or 
o a permanent impairment of a body structure or body function, or  
o inpatient or prolonged hospitalization, or  
o medical or surgical intervention to prevent life threatening illness or injury 
or permanent impairment to a body structure or a body function 
x led to fetal distress, fetal death or a congenital abnormality or birth defect.  
 
9.1.3. 
Adverse Event Reporting and Coding 
AEs will be reported on the appropriate case report form (CRF) for that visit and 
documented in the subject’s permanent medical record.  The Investigator at each Site 
is ultimately responsible for reporting AEs to the Sponsor.  
 
The following information on each reported Adverse Event will be collected:  
x Adverse Event Name 
x Adverse Event Onset Date 
x Relationship 
x Classification Serious 
x Treatment 
x Outcome 
x Resolution Date 
 
Adverse Events will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA). 
 
Adverse event submission guidelines: 

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x Adverse event reporting begins once the patient is enrolled in the study.  All 
adverse events should be reported from enrollment through study 
completion/discontinuation. 
x Provide a diagnosis if possible. If unable to provide diagnosis, report the 
symptoms as separate events. Adverse Events should be reported using the full 
name without abbreviations or narratives. 
x Adverse events with an outcome status of “Ongoing” should be assessed at each 
follow-up evaluation to determine if the event has resolved.  Adverse events 
ongoing at study completion/discontinuation should be left as “Ongoing” on the 
AE case report form.   
9.1.4. 
Subject Death 
If a subject dies while participating in the study, the cause of death will be reported as 
the adverse event and “death” reported as the event outcome on the AE case report 
form. If the subject has other ongoing adverse events at the time of death, the 
outcome status of those events should be reported as “resolved” on the AE case 
report form. 
 
The Investigator should obtain all medical records including death certificate and 
autopsy report for inclusion in reporting to the Clinical Events Committee.   
  
9.2. Unanticipated Adverse Device Effects (UADE)  
An unanticipated adverse device effect (UADE) is defined in 21 CFR 812.3(s) as 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 protocol.  
 
The Sponsor is required to notify FDA within (10) days of any unanticipated adverse device 
effect.  The Sponsor is required to notify PMDA within (15) days of any unanticipated adverse 
device effect not resulting in death; the Sponsor is required to notify PMDA within (7) days of 
any unanticipated adverse device effect resulting in death or which may result in death. If a 
complication occurs that the Investigator believes may be a potential UADE, the Site should 
immediately contact the Sponsor to determine reporting requirements.  In addition, when there 
is a reason to believe a device may have malfunctioned, causing potential harm to a patient, 
the Site should immediately notify the Sponsor. 
 
The Investigator will submit to the reviewing IRB a report of any UADE occurring during an 
investigation as soon as possible, but in no event later than ten (10) days after the Investigator 
learns of the effect.  All UADEs must be documented by the Investigator including the date of 
onset, a complete description of the event, possible reason(s) for the event, severity, duration, 
actions taken and outcome.  Copies of all supporting documents should be submitted 
concurrently with the appropriate CRF. 
 
 A report from the Sponsor will be submitted to the FDA and to all reviewing IRBs and 
participating Investigators within 10 working days after the Sponsor first receives notice of the 
effect. 

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9.3. Data and Safety Monitoring Board   
An independent Data and Safety Monitoring Board (DSMB) will oversee conduct of the study.  
The DSMB will review accumulating study safety data on a regular basis and will advise the 
Sponsor regarding the continuing safety of study subjects as well as the continuing validity and 
scientific merit of the study.  The DSMB will be comprised of an interdisciplinary team of at 
least 3 members (2 voting physicians, and one voting statistician) with pertinent expertise in 
carotid stenting who are not directly involved in the conduct of the study.  The members will be 
compensated for their involvement in the DSMB, including reimbursement for reasonable 
travel expenses to attend meetings.   
 
This committee will operate under pre-specified procedures as outlined in the DSMB Charter 
in accordance with the FDA’s Guidance for Clinical Trial Sponsors on the Establishment and 
Operation of Clinical Trial Data Monitoring Committees.  The DSMB will be responsible for 
conducting periodic reviews of aggregate data on a prescribed basis.  The frequency of data 
review and other roles and responsibilities of the DSMB will be specified in the DSMB Charter.    
 
Based on the safety data review, the DSMB will make recommendations to the Sponsor.  
Recommendations may include study continuation with or without major or minor 
modifications, temporary suspension of enrollment and / or study intervention until some 
uncertainty is resolved.  All final decisions regarding study modifications rest with the Sponsor. 
 
9.4. Clinical Events Committee  
An independent Clinical Events Committee (CEC) will review potential primary endpoint events 
and adjudicate events based on endpoint definitions in the study protocol.  The CEC will be 
comprised of an interdisciplinary team with pertinent knowledge in carotid stenting or the 
cardiovascular and/or nervous system who are not directly involved in the conduct of the 
study.  The members will be compensated for their involvement in the CEC, including 
reimbursement for reasonable travel expenses to attend meetings.   
 
This committee will operate under pre-specified procedures as outlined in the CEC Charter.   
The adjudication process will be initiated after a potential primary endpoint event is reported by 
the site. 

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10. Statistical Analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Z
Z
 
 
 
 
  
 
 
 
 

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10.4. Data Analysis 
10.4.1. Timing of Analyses 
The primary endpoint analysis will occur when enrollment and one year follow-up are 
complete. No interim analyses of the study hypotheses are planned. 
10.4.2. Baseline Characteristics 
Subject demographics, clinical history, risk factors, and preprocedure lesion 
characteristics will be summarized using descriptive statistics for continuous variables 
(mean, standard deviation, number of observations, minimum and maximum) and 
discrete variables (percentage and count/sample). 
10.4.3. Analysis Sets 
The primary endpoint will be analyzed both on an intent-to-treat basis and on a per-
protocol basis. The primary analysis set for testing of the primary endpoint is the per-
protocol analysis set. 
 
Intent-To-Treat (ITT) Analysis Set  
The ITT analysis set is defined as all enrolled subjects with adequate informed 
consent, regardless of whether the study stent was implanted. Because technical 
failures (test device attempted but not implanted) are followed only to 30 days, this 
set will be used in the analysis of safety endpoints (major, serious, and nonserious 
adverse events) to 30 days and secondary endpoints evaluated at procedure, 
discharge, and 30 days. 
 
Per-Protocol Analysis Set (Primary Analysis Set) 
For per-protocol analysis, only subjects who had the study stent implanted in the 
target vessel and had no major protocol deviations will be included in the analysis. 
Major protocol deviations are defined as protocol deviations with a level of 
seriousness such that inclusion of the subject(s) would unacceptably bias the primary 
endpoint analysis. An example of a major protocol deviation might be failure to satisfy 
eligibility criteria to a degree where the subject does not fit the underlying scientific 
model for the treatment. 
The per-protocol set will be used for the primary analyses of the primary endpoint. 
Ideally, this analysis set will consist of all subjects from the ITT set with technical 
success (test device implanted). 
The Per-Protocol set will be used in additional analyses of the primary and secondary 
endpoints. 
The primary safety and efficacy endpoints will also be analyzed controlling for the 
following baseline covariates: age, sex, and race/ethnicity. 
Additional subgroup analyses may be performed based on variables identified to be 
significant predictors (p-value<0.05) in multivariate analyses. 
 
 
 

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10.4.4. Pooling of Data 
Site data will be pooled based on clinical comparability, i.e., the sites used a common 
protocol, the sponsor adequately monitored the study to assure protocol compliance, 
and the data gathering and validation mechanisms were the same across all study 
sites. 
Analyses to justify pooling will include the following: 
x 
The primary endpoint will be presented by institution.  
x 
An assessment of the poolability of the sites using a 2-by-(number of sites) 
contingency table of MAE outcome versus site. Fisher’s Exact Test will be used to 
assess homogeneity. Sites with fewer than five subjects will be combined based 
on geographic region. 
x 
If the sites are found to be significantly heterogeneous with respect to the primary 
endpoint, additional analyses will be conducted to assess differences between 
sites in baseline and procedural variables that might explain differences in primary 
outcome. 
10.4.5. Statistical Analysis of Primary Endpoint 
The primary endpoint of 1-year MAE is subject-based. A one-sided 95.1% upper 
confidence bound will be calculated (using the standard error based on H0) and 
compared to the prespecified performance goal. If this bound is less than the 
performance goal, then the primary endpoint is met and the GORE® Carotid Stent 
will have demonstrated acceptable performance. The P value for the corresponding 
one-sided normal approximation to the binomial test will be reported. The primary 
hypothesis test will use D=0.049 to ensure an overall Type-1 error rate d0.05. 
10.4.6. Sensitivity Analyses 
Sensitivity analyses of the primary endpoint will be conducted and will include, at a 
minimum, a worst-case analysis and tipping point analysis. 
10.4.7. Statistical Analysis of Secondary Endpoint(s) 
Secondary endpoints (subject-based unless otherwise specified) will be descriptive 
only; no formal statistical hypotheses will be tested. Secondary endpoints will be 
summarized at the specified time points using the descriptive statistics described 
above. No claims of statistical significance will be made based on secondary endpoint 
results. P values from these tests will not be reported in labeling, but may be used for 
scientific presentations and/or manuscripts. 
10.5. Publication Plan  
The International Committee of Medical Journal Editors (ICMJE) member journals have 
adopted a trials-registration policy as a condition for publication.  This policy requires that all 
clinical trials be registered in a public trials registry.  The Sponsor will register the study and 
post results as required by this policy and applicable U.S. laws and regulations.   
 

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It is the intent of the sponsor that the multicenter results of this study will be submitted for 
publication.  A publications committee will be established to review the multicenter results and 
develop publications at the completion of the study.  The timing of the multicenter publication 
may be dependent on regulatory submissions and approvals.  Individual investigative sites 
should coordinate requests for publication through the publications committee or the sponsor. 
11. Ethical and Regulatory Considerations 
11.1. Statement of Compliance  
The study will be conducted in compliance with this protocol, International Conference on 
Harmonization Good Clinical Practice E6 (ICH-GCP), and applicable local regulatory 
requirements.    
 
The following are applicable to this study:   
21 CFR Part 11 
 
Electronic Records; Electronic Signatures 
21 CFR Part 50 
 
Protection of Human Subjects 
21 CFR Part 54 
 
Financial Disclosure By Clinical 
Investigators 
21 CFR Part 56 
 
Institutional Review Boards 
21 CFR Part 812 
 
Investigational Device Exemptions 
ICH-GCP E6 
International Conference on 
Harmonisation Regulations Guideline For 
Good Clinical Practice 
  
11.2. Compliance Responsibilities 
The Sponsor will conduct the clinical study in accordance with all applicable regulations and 
laws.  The Sponsor will be responsible for documenting that Investigators have the necessary 
skills, training and information to properly conduct the clinical study.  The Sponsor will ensure 
proper monitoring of the clinical study and ensure the Site has obtained IRB approval prior to 
enrollment.  The Sponsor will provide information to the Investigators, the reviewing IRB and 
governing regulatory agencies concerning the progress and any new material information 
about the clinical study.   
The Investigator will conduct the clinical study in accordance with all applicable regulations 
and laws, any relevant agreements, the study protocol, and all approval conditions of the 
reviewing IRB and governing regulatory agencies.  The Investigator will ensure IRB approval is 
obtained prior to enrollment, maintained throughout the course of the study, and that all IRB 
reporting requirements are met.  The Investigator is responsible for protecting the rights, 
safety, and welfare of subjects under the Investigator’s care and for the control of devices 
under investigation.  The Investigator is also responsible for ensuring that informed consent is 
properly obtained.  
 
 

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11.3. Informed Consent  
The Investigator shall ensure that all potential subjects for this study are provided with a 
consent form describing this study and sufficient information to make an informed decision 
about their participation.   
 
The formal consent of a subject, using the IRB-approved consent form, must be obtained by 
the Investigator before that subject undergoes any study procedure.  The consent form will be 
signed and personally dated by the subject, and the person who conducted the informed 
consent discussion.  The original signed informed consent form will be retained in the subject 
records.  A copy of the informed consent document will be given to the subject for their 
records.   Any significant, new information which emerges while the study is in progress that 
may influence a subject’s willingness to continue to take part in the study will be provided. 
 
The Investigator shall ensure that documentation of the acquisition of informed consent is 
recorded in each subject’s records in accordance with applicable regulations. 
11.4. Independent Ethical Review  
The Investigator shall not enroll any subjects prior to obtaining approval for the study from a 
properly constituted independent IRB. 
  
The Investigator will submit the protocol, informed consent forms, and other information to be 
provided to subjects, such as survey instruments or questionnaires, and any proposed 
advertising/recruitment materials for written approval. 
11.5. Conflict of Interest 
All Investigators will follow their Site’s conflict of interest policies.   
 
Investigators will provide Sponsor with sufficient accurate financial disclosure information to 
allow Sponsor to submit a complete and accurate certification or disclosure statement as 
required under 21 CFR 54, Financial Disclosure by Clinical Investigators.  Investigators will 
promptly update this information if any relevant changes occur during the course of the 
investigation and for one (1) year following completion of the study. 
11.6. Confidentiality 
All subject records will be kept confidential to the extent provided by applicable laws and 
regulations.  The study monitors and other authorized representatives of the Sponsor may 
inspect all documents and records required to be maintained by the Investigator, including but 
not limited to medical records.   
 
Such records may also be reviewed by the Site’s IRB and other regulatory bodies. 
 
The Investigator will inform the subjects that their records may be reviewed.  

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12. References 
 
1 Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. Endarterectomy for asymptomatic 
carotid artery stenosis.. JAMA 1995; 273:1421-8. 
2 American Heart Association.  Heart Disease and Stroke Statistics – 2006 Update. Dallas, TX. 
3 Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. North 
American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med 1991;32: 445-53. 
4 Moore WS, Barnett HJ, Beebe HG, Bernstein EF, Brener BJ, Brott R et al. Guidelines for carotid endarterectomy. 
A multidisciplinary consensus statement from the Ad Hoc Committee, American Heart Association. Circulation 
1995;91:566-79. 
5 Greenstein AJ, Chassin MR,et al. Association between minor and major surgical complications after carotid 
endarterectomy: Results of the New York Carotid Artery Surgery study. J Vasc Surg 2007;46:1138-46. 
6 Yadav JS, Wholey MH, Kuntz RE, et al :  Protected carotid-artery stenting versus endarterectomy in high risk 
patients.  N Engl J Med 2004;351:1493-1501 
7 Hassoun HT, Malas MB, Freischlag JA.  Secondary Stroke Prevention in the Era of Carotid Stenting. Arch Surg 
2010;145(10)L928-935. 
8 Chung C, Shah TR, Han D, Marin ML, Faries PL.  Carotid Stenting Trials:  What Have they Taught Us? Persp in 
Vasc Surg and Endovasc Ther 2010;22(2):93-103. 
9 Brott TG, Hobson RW, Howeard G, et al.  Stenting versus endarterectomy for treatment of carotid artery stenosis.  
N Engl J Med 2010;363:11-23. 
10 Pierce DS, Rosero EB, Modrall G, et al.  Open-cell versus closed-cell stent design differences in blood flow 
velocities after carotid stenting.  J Vasc Surg 2009;49:602-6. 
11 Siewiorek GM, Endor FA, Wholey MH.  Clinical Significance and Technical Assessment of Stent Cell Geometry 
in Carotid Artery Stenting.  J Endovasc Ther 2009;16:178-188. 
12 Müller-Hülsbeck S, Preuß H, Elhöft H.  CAS: Which stent for which lesion.  J Cardovasc Surg 2009;50:767-72.  
13 Hathout GM, Fink JR, El-Saden SM, Grant EG. Sonographic NASCET Index: A New Doppler Parameter for 
Assessment of Internal Carotid Artery Stenosis. Am J Neurorad 2005;26:68-75. 
14 AbuRahma AF, Snodgrass KR, Robinson PA, Wood DJ, Meek RB, Patton DJ. Safety and durability of redo 
carotid endarterectomy for recurrent carotid artery stenosis. Am J Surg 1994;168:175–8. 
15 Das MB, Hertzer NR, Ratliff NB, O’Hara PJ, Beven EG. Recurrent carotid stenosis. A five year series of 65 
operations. Ann Surg 1985;202:28–35. 
16 Francfort JW, Gallagher JF, Penman E, Fairman RM. Surgery for radiation- induced symptomatic carotid 
atherosclerosis. Ann Vasc Surg 1989;3:14–9. 
17 Gasecki AP, Eliasziw M, Ferguson GG, Hachinski V, Barnett HJ. Long-term prognosis and effect of 
endarterectomy in patients with severe carotid stenosis and contralateral carotid stenosis or occlusion: results 
from NASCET. North American Symptomatic Carotid Endarterectomy Trial (NASCET) group. J Neurosurg 
1995;83:778–82. 
18 Goldstein LB, McCrory DB, Landsman PB, et al. Multi-center review of preoperative risk factors for carotid 
endarterectomy in patients with ipsilateral symptoms. Stroke 1994;25:1116–21. 
19 Goldstein LB, Samsa GP, Machtar DB, Oddone EZ. Multi-center review of preoperative risk factors for 
endarterectomy for asymptomatic carotid artery stenosis. Stroke 1998;29:750–3. 
20 Hamdan AD, Pomposelli FB, Jr., Gibbons GW, Campbell DR, LoGerfo FW. Renal insufficiency and altered 
postoperative risk in carotid endarterectomy. J Vasc Surg 1999;29:1006–11. 
21 Hertzer NR, O’Hara PJ, Mascha EJ, Krajewski LP, Sullivan TM, Beven EG. Early outcome assessment for 2228 
carotid endarterectomy procedures: the Cleveland Clinic experience from 1989 to 1995. J Vasc Surg 1997;26:1–
10. 
22 Little NS, Meyer FB. Carotid endarterectomy: indications, techniques, and Mayo Clinic experience. Neuro Med 
Chir (Tokyo) 1997;37:227–35. 
23 Magnadottir HB, Lightdale N, Harbaugh RE. Clinical outcomes for patients at high risk who underwent carotid 
endarterectomy with regional anesthesia. Neurosurgery 1999;45:786–9. 
24 McCrory DB, Goldstein LB, Samsa GP, Landsman PB, Moore WS, Machtar DB. Predicting complications of 
carotid endarterectomy. Stroke 1993;24:1285–91. 

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25 Meyer FB, Meissner I, Fode NC, Losasso TJ. Carotid endarterectomy in elderly patients. Mayo Clin Proc 
1991;66:464–9. 
26 O’Hara PJ, Hertzer NR, Mascha EJ, Beven EG, Krajewski LP, Sullivan TM. Carotid endarterectomy in 
octogenarians: early results and late outcomes. J Vasc Surg 1998;27:860–71. 
27 Rigdon EE, Monajjem N, Rhodes RS. Is carotid endarterectomy justified in patients with severe chronic renal 
insufficiency? Ann Vasc Surg 1997;11:115–9. 
28 Rockman CB, Riles TS, Fisher FS, Adelman MA, Lamprello PJ. The surgical management of carotid artery 
stenosis in patients with previous neck irradiation. Am J Surg 1996;172:191–5. 
29 Rothwell PM, Slattery J, Warlow CP. Clinical and angiographic predictors of stroke and death from carotid 
endarterectomy: systematic review. BMJ 1997;315:1571–7. 
30 Sternbergh WC, III, Garrard CL, Gonze MD, Manord JD, Bowen JC, Money SR. Carotid endarterectomy in 
patients with significant renal dysfunction. J Vasc Surg 1999;29:672–7. 
31 Gray WA, Hopkins LN, Yadav S. Protected carotid stenting in high-surgical-risk patients: The ARCHeR results. J 
Vasc Surg 2006; 44:258-68. 
32 Iyer SS, White CJ, Hopkins LN. Carotid Artery Revascularization in High-Surgical-Risk Patients Using the Carotid 
WALLSTENT and FilterWire EX/EZ. JACC 2008; 51: 427-34. 
33 Hopkins LN, Myla S, Grube E. Carotid Artery Revascularization in High Surgical Risk Patients With the NexStent 
and FilterWire EX/EZ: 1-Year Results in the CABERNET Trial. CCI 2008; 71: 950-60. 
34 Summary of Safety and Effectiveness Data: Protege® Carotid Stent System 
35 Summary of Safety and Effectiveness Data: Exponent Self-Expanding Carotid Stent with OTW Delivery System 
36 Summary of Safety and Effectiveness Data: Precise Nitinol Stent System 
37 Summary of Safety and Effectiveness Data: Xact Carotid Stent System 
 
 

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13. Study-Specific Appendices 
Appendix A NIH Stroke Scale 
Appendix B Modified Rankin Scale 
 

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Appendix A 
NIH Stroke Scale 

 
 
 
 
Patient Identification. ___ ___-___ ___ ___-___ ___ ___ 
 
     Pt. Date of Birth ___ ___/___ ___/___ ___ 
 
Hospital ________________________(___ ___-___ ___) 
 
Date of Exam ___ ___/___ ___/___ ___ 
 
           
 
Interval: [ ] Baseline 
[ ] 2 hours post treatment    [ ] 24 hours post onset of symptoms ±20 minutes    [ ] 7-10 days          
 
[ ] 3 months [ ] Other ________________________________(___ ___) 
 
Time: ___ ___:___ ___   [ ]am   [ ]pm 
 
Person Administering Scale _____________________________________  
 
Administer stroke scale items in the order listed.  Record performance in each category after each subscale exam.  Do not go 
back and change scores.  Follow directions provided for each exam technique.  Scores should reflect what the patient does, not 
what the clinician thinks the patient can do.  The clinician should record answers while administering the exam and work quickly. 
Except where indicated, the patient should not be coached (i.e., repeated requests to patient to make a special effort). 
 
Instructions 
  Scale Definition 
Score 
1a.  Level of Consciousness: The investigator must choose a 
response if a full evaluation is prevented by such obstacles as an 
endotracheal tube, language barrier, orotracheal trauma/bandages.  A 
3 is scored only if the patient makes no movement (other than reflexive 
posturing) in response to noxious stimulation. 
 
 0 =    Alert; keenly responsive. 
 1 = Not alert; but arousable by minor stimulation to obey, 
answer, or respond. 
 2 = Not alert; requires repeated stimulation to attend, or is 
obtunded and requires strong or painful stimulation to 
make movements (not stereotyped). 
 3 = Responds only with reflex motor or autonomic effects or 
totally unresponsive, flaccid, and areflexic. 
 
 
 
 
______ 
1b.  LOC Questions:  The patient is asked the month and his/her age. 
The answer must be correct - there is no partial credit for being close.  
Aphasic and stuporous patients who do not comprehend the questions 
will score 2.  Patients unable to speak because of endotracheal 
intubation, orotracheal trauma, severe dysarthria from any cause, 
language barrier, or any other problem not secondary to aphasia are 
given a 1.  It is important that only the initial answer be graded and that 
the examiner not "help" the patient with verbal or non-verbal cues. 
 0 = 
Answers both questions correctly. 
 
 1 = 
Answers one question correctly. 
 
 2 = 
Answers neither question correctly.  
 
 
 
 
 
 
______ 
1c.  LOC Commands:  The patient is asked to open and close the 
eyes and then to grip and release the non-paretic hand.  Substitute 
another one step command if the hands cannot be used.  Credit is 
given if an unequivocal attempt is made but not completed due to 
weakness.  If the patient does not respond to command, the task 
should be demonstrated to him or her (pantomime), and the result 
scored (i.e., follows none, one or two commands).  Patients with 
trauma, amputation, or other physical impediments should be given 
suitable one-step commands.  Only the first attempt is scored. 
 0 = Performs both tasks correctly. 
 
 1 = Performs one task correctly. 
 
 2 = Performs neither task correctly. 
 
 
 
 
 
 
______ 
2.  Best Gaze:  Only horizontal eye movements will be tested.  
Voluntary or reflexive (oculocephalic) eye movements will be scored, 
but caloric testing is not done.  If the patient has a conjugate 
deviation of the eyes that can be overcome by voluntary or reflexive 
activity, the score will be 1.  If a patient has an isolated peripheral 
nerve paresis (CN III, IV or VI), score a 1.  Gaze is testable in all 
aphasic patients.  Patients with ocular trauma, bandages, pre-existing 
blindness, or other disorder of visual acuity or fields should be tested 
with reflexive movements, and a choice made by the investigator.  
Establishing eye contact and then moving about the patient from side 
to side will occasionally clarify the presence of a partial gaze palsy.   
 0 = Normal. 
 
 1 = Partial gaze palsy; gaze is abnormal in one or both eyes, 
but forced deviation or total gaze paresis is not present. 
 
 2 = Forced deviation, or total gaze paresis not overcome by the 
oculocephalic maneuver. 
 
 
 
______ 
 
 
Rev 10/1/2003 

 
 
 
 
Patient Identification. ___ ___-___ ___ ___-___ ___ ___ 
 
     Pt. Date of Birth ___ ___/___ ___/___ ___ 
 
Hospital ________________________(___ ___-___ ___) 
 
Date of Exam ___ ___/___ ___/___ ___ 
 
           
 
Interval: [ ] Baseline 
[ ] 2 hours post treatment    [ ] 24 hours post onset of symptoms ±20 minutes    [ ] 7-10 days          
 
[ ] 3 months [ ] Other ________________________________(___ ___) 
 
 
3.  Visual:  Visual fields (upper and lower quadrants) are tested by 
confrontation, using finger counting or visual threat, as appropriate.  
Patients may be encouraged, but if they look at the side of the 
moving fingers appropriately, this can be scored as normal.  If there is 
unilateral blindness or enucleation, visual fields in the remaining eye 
are scored.  Score 1 only if a clear-cut asymmetry, including 
quadrantanopia, is found.  If patient is blind from any cause, score 3.  
Double simultaneous stimulation is performed at this point.  If there is 
extinction, patient receives a 1, and the results are used to respond to 
item 11. 
 0 = No visual loss. 
 
 1 = Partial hemianopia. 
 
 2 = Complete hemianopia. 
 
 3 = Bilateral hemianopia (blind including cortical blindness). 
  
 
 
 
______ 
4.  Facial Palsy:  Ask – or use pantomime to encourage – the patient 
to show teeth or raise eyebrows and close eyes.  Score symmetry of 
grimace in response to noxious stimuli in the poorly responsive or 
non-comprehending patient.  If facial trauma/bandages, orotracheal 
tube, tape or other physical barriers obscure the face, these should 
be removed to the extent possible. 
 0 = Normal symmetrical movements. 
 1 = Minor paralysis (flattened nasolabial fold, asymmetry on 
smiling). 
 2 = Partial paralysis (total or near-total paralysis of lower 
face). 
 3 = Complete paralysis of one or both sides (absence of 
facial movement in the upper and lower face). 
 
 
 
______ 
5.  Motor Arm:  The limb is placed in the appropriate position: extend 
the arms (palms down) 90 degrees (if sitting) or 45 degrees (if 
supine).  Drift is scored if the arm falls before 10 seconds.  The 
aphasic patient is encouraged using urgency in the voice and 
pantomime, but not noxious stimulation.  Each limb is tested in turn, 
beginning with the non-paretic arm.  Only in the case of amputation or 
joint fusion at the shoulder, the examiner should record the score as 
untestable (UN), and clearly write the explanation for this choice. 
  0 =  No drift; limb holds 90 (or 45) degrees for full 10 seconds. 
  1 =  Drift; limb holds 90 (or 45) degrees, but drifts down before 
full 10 seconds; does not hit bed or other support. 
  2 =  Some effort against gravity; limb cannot get to or 
maintain (if cued) 90 (or 45) degrees, drifts down to bed, 
but has some effort against gravity. 
  3 =  No effort against gravity; limb falls. 
  4 =  No movement. 
  UN = Amputation or joint fusion, explain:  _____________________ 
 
 5a.  Left Arm 
 
 
 5b.  Right Arm  
 
  
  
  
  
   
 
 
 
 
 
 
 
 
 
 
 
 
______ 
 
______ 
 
 
 
 
6.  Motor Leg:  The limb is placed in the appropriate position:  hold 
the leg at 30 degrees (always tested supine).  Drift is scored if the leg 
falls before 5 seconds.  The aphasic patient is encouraged using 
urgency in the voice and pantomime, but not noxious stimulation.  
Each limb is tested in turn, beginning with the non-paretic leg.  Only 
in the case of amputation or joint fusion at the hip, the examiner 
should record the score as untestable (UN), and clearly write the 
explanation for this choice. 
  0 =  No drift; leg holds 30-degree position for full 5 seconds. 
  1 =  Drift; leg falls by the end of the 5-second period but does 
not hit bed.    
  2 =  Some effort against gravity; leg falls to bed by 5 
seconds, but has some effort against gravity. 
  3 =  No effort against gravity; leg falls to bed immediately. 
  4 =  No movement. 
  UN = Amputation or joint fusion, explain: ________________ 
 
6a.  Left Leg 
 
6b.  Right Leg 
 
 
 
 
 
 
 
 
 
______ 
 
 
 
Rev 10/1/2003 

 
 
 
 
Patient Identification. ___ ___-___ ___ ___-___ ___ ___ 
 
     Pt. Date of Birth ___ ___/___ ___/___ ___ 
 
Hospital ________________________(___ ___-___ ___) 
 
Date of Exam ___ ___/___ ___/___ ___ 
 
           
 
Interval: [ ] Baseline 
[ ] 2 hours post treatment    [ ] 24 hours post onset of symptoms ±20 minutes    [ ] 7-10 days          
 
[ ] 3 months [ ] Other ________________________________(___ ___) 
 
______ 
7.  Limb Ataxia:  This item is aimed at finding evidence of a unilateral 
cerebellar lesion.  Test with eyes open.  In case of visual defect, 
ensure testing is done in intact visual field.  The finger-nose-finger 
and heel-shin tests are performed on both sides, and ataxia is scored 
only if present out of proportion to weakness.  Ataxia is absent in the 
patient who cannot understand or is paralyzed.  Only in the case of 
amputation or joint fusion, the examiner should record the score as 
untestable (UN), and clearly write the explanation for this choice.  In 
case of blindness, test by having the patient touch nose from 
extended arm position. 
 0 = Absent. 
 
 1 = Present in one limb. 
 
 2 = Present in two limbs. 
 
 UN = Amputation or joint fusion, explain:  ________________ 
  
 
 
 
______ 
 
 
 
 
8.  Sensory:  Sensation or grimace to pinprick when tested, or 
withdrawal from noxious stimulus in the obtunded or aphasic patient.  
Only sensory loss attributed to stroke is scored as abnormal and the 
examiner should test as many body areas (arms [not hands], legs, 
trunk, face) as needed to accurately check for hemisensory loss.  A 
score of 2, “severe or total sensory loss,” should only be given when 
a severe or total loss of sensation can be clearly demonstrated.  
Stuporous and aphasic patients will, therefore, probably score 1 or 0. 
The patient with brainstem stroke who has bilateral loss of sensation 
is scored 2.  If the patient does not respond and is quadriplegic, score 
2.  Patients in a coma (item 1a=3) are automatically given a 2 on this 
item. 
 0 = Normal; no sensory loss. 
 
 1 = Mild-to-moderate sensory loss; patient feels pinprick is 
less sharp or is dull on the affected side; or there is a 
loss of superficial pain with pinprick, but patient is aware 
of being touched. 
 
 2 = Severe to total sensory loss; patient is not aware of 
being touched in the face, arm, and leg. 
 
 
 
 
 
______ 
9.  Best Language:  A great deal of information about comprehension 
will be obtained during the preceding sections of the examination.  
For this scale item, the patient is asked to describe what is happening 
in the attached picture, to name the items on the attached naming 
sheet 
and 
to 
read 
from 
the 
attached 
list 
of 
sentences.  
Comprehension is judged from responses here, as well as to all of 
the commands in the preceding general neurological exam.  If visual 
loss interferes with the tests, ask the patient to identify objects placed 
in the hand, repeat, and produce speech.  The intubated patient 
should be asked to write. The patient in a coma (item 1a=3) will 
automatically score 3 on this item.  The examiner must choose a 
score for the patient with stupor or limited cooperation, but a score of 
3 should be used only if the patient is mute and follows no one-step 
commands. 
 0 = No aphasia; normal. 
 
 1 =  Mild-to-moderate aphasia; some obvious loss of fluency 
or facility of comprehension, without significant 
limitation on ideas expressed or form of expression.  
Reduction of speech and/or comprehension, however, 
makes conversation about provided materials difficult 
or impossible.  For example, in conversation about 
provided materials, examiner can identify picture or 
naming card content from patient’s response. 
 
 2 = Severe aphasia; all communication is through fragmentary 
expression; great need for inference, questioning, and guessing 
by the listener.  Range of information that can be exchanged is 
limited; listener carries burden of communication.  Examiner 
cannot identify materials provided from patient response. 
 
 3 = Mute, global aphasia; no usable speech or auditory 
comprehension. 
 
 
 
 
 
 
 
 
 
______ 
10.  Dysarthria: If patient is thought to be normal, an adequate 
sample of speech must be obtained by asking patient to read or 
repeat words from the attached list.  If the patient has severe 
aphasia, the clarity of articulation of spontaneous speech can be 
rated.  Only if the patient is intubated or has other physical barriers to 
producing speech, the examiner should record the score as 
untestable (UN), and clearly write an explanation for this choice.  Do 
not tell the patient why he or she is being tested. 
 0 = Normal. 
 1 = Mild-to-moderate dysarthria; patient slurs at least some 
words and, at worst, can be understood with some 
difficulty. 
 2 = Severe dysarthria; patient's speech is so slurred as to be 
unintelligible in the absence of or out of proportion to 
any dysphasia, or is mute/anarthric. 
UN = Intubated or other physical barrier, 
explain:_____________________________ 
 
 
 
______ 
 
Rev 10/1/2003 

 
 
 
 
Patient Identification. ___ ___-___ ___ ___-___ ___ ___ 
 
     Pt. Date of Birth ___ ___/___ ___/___ ___ 
 
Hospital ________________________(___ ___-___ ___) 
 
Date of Exam ___ ___/___ ___/___ ___ 
 
           
 
Interval: [ ] Baseline 
[ ] 2 hours post treatment    [ ] 24 hours post onset of symptoms ±20 minutes    [ ] 7-10 days          
 
[ ] 3 months [ ] Other ________________________________(___ ___) 
 
 
11.  Extinction and Inattention (formerly Neglect):  Sufficient 
information to identify neglect may be obtained during the prior 
testing.  If the patient has a severe visual loss preventing visual 
double simultaneous stimulation, and the cutaneous stimuli are 
normal, the score is normal.  If the patient has aphasia but does 
appear to attend to both sides, the score is normal.  The presence of 
visual spatial neglect or anosagnosia may also be taken as evidence 
of abnormality.  Since the abnormality is scored only if present, the 
item is never untestable.   
 0 = No abnormality. 
 
 1 = Visual, tactile, auditory, spatial, or personal inattention 
or extinction to bilateral simultaneous stimulation in one 
of the sensory modalities. 
 
 2 = Profound hemi-inattention or extinction to more than 
one modality; does not recognize own hand or orients 
to only one side of space. 
 
 
 
______ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______ 
 
______ 
 
 
 
 
 
 
 
 
 
Rev 10/1/2003 

 
 
You know how. 
 
 
Down to earth. 
 
 
I got home from work. 
 
 
Near the table in the dining 
room. 
 
 
They heard him speak on the 
radio last night. 
 
 

 
 

 
 
 
MAMA 
 
TIP – TOP 
 
FIFTY – FIFTY 
 
THANKS 
 
HUCKLEBERRY 
 
BASEBALL PLAYER 
 

GORE® Carotid Stent  
MD134865 GCS 10-08 PROT Revision#: 3 Doc Type: SP 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1 
 
Page 63  
Doc Type: GC 
Appendix B 
Modified Rankin Scale 

Patient’s name:
Hospital number:
MODIFIED RANKIN
SCALE
CHECK ONE
GRADE ONLY                                           
                                                                                             DESCRIPTION
0
...........
No symptoms at all.
1
...........
No significant disability despite symptoms:  
Able to carry out all usual activities.
2
...........
Slight disability.
3
...........
Moderate disability:
Requiring some help but able to walk without assistance.
4
...........
Moderate to severe disability:
Unable to walk without assistance and unable to attend
to own bodily needs without assistance.
5
...........
Severe disability:
Bedridden, incontinent and requiring constant nursing
care and attention.
6
...........
Death.