Post-market Study: Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm
Conditions: Popliteal Artery Aneurysm
Sponsor: W.L.Gore & Associates

CONFIDENTIAL INFORMATION 
MD133246 Protocol Template 
 
Page 1 of 1 
Revision#: 5  
Doc Type: GC 
 
 
Nothing herein is to be disclosed in any way without the prior 
express written permission of W. L. Gore & Associates, Inc. 
 
 
 
 
Post-market study: Evaluation of the GORE® VIABAHN® Endoprosthesis for the 
treatment of Popliteal Artery Aneurysm 
 
 
 
 
 
Protocol number: FPR 14-03 
 
Protocol date: 14-JULY-2015 
 
NCT number: NCT02462876 
 
 
 
 
 
 
 
 
W. L. Gore & Associates, Inc. 
Medical Products Division 

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1MD134619.docx 
 
Page i  
Doc Type: GC 
Nothing herein is to be disclosed in any way without the prior 
express written permission of W. L. Gore & Associates, Inc. 
 
 
 
Post-market study: Evaluation of the GORE® VIABAHN® Endoprosthesis 
 for the treatment of Popliteal Artery Aneurysm 
 
 
 
Protocol Number: 
 
FPR 14-03 
 
 
 
 
 
 
Amendment 1:  
 
14 July 2015 
 
 
 
 
 
 
 
 
 
W. L. Gore & Associates, Inc. 
Medical Products Division 
 
 
 

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1MD134619.docx 
 
Page ii  
Doc Type: GC 
PROTOCOL SUMMARY 
Study Title 
Post-market study: Evaluation of the GORE® VIABAHN® 
Endoprosthesis for the treatment of Popliteal Artery 
Aneurysm   
Protocol Number 
FPR 14-03 
Sponsor 
W. L. Gore & Associates, Inc.  
Medical Products Division 
1801 W. Route 66, Suite 117 
P.O. Box 2400  
Flagstaff, AZ 86003-2400 
United States 
Telephone: +1 800-528-1866 
Study Medical Device 
GORE® VIABAHN® Endoprosthesis; CE marked medical 
device 
Study Design 
This is a French multicenter, non-randomized, single arm, 
retrospective Post-market study with a prospective follow-up 
of GORE® VIABAHN® Endoprosthesis for the treatment of 
Popliteal Artery Aneurysm (PAA).  
Study Objective 
The primary objective is to document the long term safety 
and performance of the GORE® VIABAHN® Endoprosthesis 
for the treatment of patients with Popliteal Artery 
Aneurysms. 
Study Endpoints 
The primary performance endpoint for this trial is: 
• 
Primary patency at 12 months 
The primary safety endpoint of this trial is: 
• 
12 month serious adverse events and adverse 
events related to the study procedure or the study 
device. 
The secondary endpoints of this trial are: 
• 
Serious adverse events and adverse events related 
to the study procedure or the study device at 24 & 
36 months; 
• 
Freedom from limb loss on the study limb through 
12, 24 & 36 months; 
• 
Freedom from repeat intervention at 12, 24 & 36 
months; 
• 
Length of hospital stay after procedure in days; 
• 
Length of procedure in minutes;  
• 
Primary patency at 24 & 36 months;  
• 
Primary assisted patency at 12, 24 & 36 months;  
• 
Secondary patency at 12, 24 & 36 months.  
• 
Technical Success 
Listings: 

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1MD134619.docx 
 
Page iv  
Doc Type: GC 
 
LIST OF ABBREVIATIONS 
AAA 
Abdominal Aortic Aneurysm 
ABI 
Ankle-Brachial Index 
AE 
Adverse Event 
CCTIRS 
French Advisory Committee on Information Processing in 
Material Research in the Field of Health 
CNIL 
French Data Protection Agency 
CDMS 
Clinical Data Management System 
CE 
Conformité Européenne 
CRF 
Case Report Form 
ePTFE 
Expanded Polytetrafluoroethylene 
Fr 
French (sizing) 
GCP 
Good Clinical Practice 
ICH 
IFU 
International Conference on Harmonization 
Instruction for Use 
MedDRA 
Medical Dictionary for Regulatory Activities 
PAA 
PI 
Popliteal Artery Aneurysm 
Principal Investigator 
SAE 
Serious Adverse Event 
UADE 
Unanticipated Adverse Device Effect 
 

*25(9,$%$+1(QGRSURVWKHVLV 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 


CONFIDENTIAL INFORMATION                         
0'3URWRFRO7HPSODWH
5HYLVLRQ0'GRF[

3DJHY
'RF7\SH*&
35272&2/6800$5<LL 
/,672)$%%5(9,$7,216  LY
 ,QWURGXFWLRQ 
 
'LVHDVH 
 
+LVWRULFDO7UHDWPHQWV 
 
6WXG\'HYLFH'HVFULSWLRQ 
 
&OLQLFDO'DWD 
 
2YHUDOO'DWD5HYLHZ 
 
6DIHW\'DWD 
 6WXG\2EMHFWLYHV 
 
3ULPDU\2EMHFWLYHV 
 
6HFRQGDU\2EMHFWLYHV 
 6WXG\'HVLJQ 
 
6WXG\'HVLJQ6FKHPD 
 
'HVFULSWLRQRI6WXG\'HVLJQ 
 
6WXG\(QGSRLQWV 
 
'HILQLWLRQV 
 
3ULPDU\(QGSRLQWV 
 
6HFRQGDU\(QGSRLQWV 
 
/LVWLQJV 
 6WXG\3RSXODWLRQ 
 
'HVFULSWLRQRI3RSXODWLRQ 
 
,QFOXVLRQ&ULWHULD 
 
([FOXVLRQ&ULWHULD 
 
3DWLHQWVHOHFWLRQ 
6WXG\3URFHGXUHV(YDOXDWLRQV  
 
6FKHGXOHRI(YHQWV 
 
,QIRUPHG&RQVHQW3URFHVV 
 
3UH6FUHHQLQJ6FUHHQLQJ 
 
(QUROOPHQW 
 
3URFHGXUH 
 
5HSHDW,QWHUYHQWLRQV 
 
)ROORZ8S 
 
6$(VDQGGHYLFHRUSURFHGXUHUHODWHG$(V 
 
0HGLFDWLRQV 
 
&OLQLFDO$VVHVVPHQW 
 
&RORU)ORZ'XSOH[8OWUDVRXQG 
 
6XEMHFW:LWKGUDZDOIURPWKH&OLQLFDO6WXG\ 
 
6XEMHFW6WXG\&RPSOHWLRQ 
 
'HYLFH'HILFLHQFLHV 
 
([SODQW3URFHGXUHV 
 
'XUDWLRQRI,QYHVWLJDWLRQ 
 6WXG\$GPLQLVWUDWLRQ 
 
7UDLQLQJ 
 
0RQLWRULQJ 
 
6LWH,QLWLDWLRQ 

*25(9,$%$+1(QGRSURVWKHVLV 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 


CONFIDENTIAL INFORMATION                         
0'3URWRFRO7HPSODWH
5HYLVLRQ0'GRF[

3DJHYL
'RF7\SH*&
 
3HULRGLF6LWH0RQLWRULQJ 
 
'HYLFH$FFRXQWDELOLW\DQG6WRUDJH 
 
3URWRFRO'HYLDWLRQV 
 
3URWRFRO$PHQGPHQWV 
 
$FFHVVWR6RXUFH'DWD'RFXPHQWV 
 
6WXG\5HFRUGV5HWHQWLRQ 
 
3XEOLFDWLRQ3ODQ 
'DWD&ROOHFWLRQDQG6XEPLVVLRQ  
 
'DWD&ROOHFWLRQ0HWKRGV 
 
'DWD&ODULILFDWLRQDQG&RUUHFWLRQ 
 
&5)&RPSOHWLRQ6FKHGXOH 
 5LVN$VVHVVPHQW 
 
3RWHQWLDO5LVNV 
 
0LQLPL]DWLRQRI5LVNV 
 
6XPPDU\RI([SHFWHG%HQHILWV 
 
5LVNWR%HQHILW5DWLRQDOH 
 $GYHUVH(YHQWVDQG6DIHW\0RQLWRULQJ 
 
$QWLFLSDWHG$GYHUVH(YHQWV 
 
$GYHUVH(YHQW5HODWLRQVKLS 
 
$GYHUVH(YHQW&ODVVLILFDWLRQ 
 
$GYHUVH(YHQW5HSRUWLQJDQG&RGLQJ 
 
6XEMHFW'HDWK 
 
8QDQWLFLSDWHG$GYHUVH'HYLFH(IIHFWV8$'( 
 6WDWLVWLFDO$QDO\VLV 
 
6WXG\2EMHFWLYHV 
 
6DPSOH6L]H'HWHUPLQDWLRQ 
 
'DWD$QDO\VLV 

7LPLQJRI$QDO\VHV 

$QDO\VLV3RSXODWLRQV 

3RROLQJRI'DWD 

3ULPDU\(QGSRLQWV 

6HFRQGDU\(QGSRLQWV 
 
&RQWURORI%LDV 
 
'DWD$QDO\VLV 
 (WKLFDODQG5HJXODWRU\&RQVLGHUDWLRQV 
 
6WDWHPHQWRI&RPSOLDQFH 
 
&RPSOLDQFH5HVSRQVLELOLWLHV 
 
,QIRUPHG&RQVHQW 
 
&RQIOLFWRI,QWHUHVW 
 
&RQILGHQWLDOLW\ 
 
6WXG\'LVFRQWLQXDWLRQRU6XVSHQVLRQ 
 5HIHUHQFHV

*25(9,$%$+1(QGRSURVWKHVLV 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 


CONFIDENTIAL INFORMATION                         
0'3URWRFRO7HPSODWH
5HYLVLRQ
'RF7\SH*&

RI

,QWURGXFWLRQ
 'LVHDVH
3RSOLWHDO$UWHU\$QHXU\VPV3$$VDUHWKHPRVWSUHYDOHQWW\SHRISHULSKHUDODUWHULDO
DQHXU\VPDFFRXQWLQJIRUWRRIDOOSHULSKHUDODQHXU\VPVZLWKDQRYHUDOOSUHYDOHQFHRI
DERXWLQKRVSLWDOL]HGSDWLHQWV$WPRVWWKLVFRUUHVSRQGVWRIRXURUILYHSDWLHQWVSHU\HDU
DWDQ\PDMRUYDVFXODUFHQWHULQWKH8QLWHG6WDWHV86>@7KHSRSOLWHDODUWHU\LVFRQVLGHUHG
DQHXU\VPDORQFHWKHGLDPHWHUUHDFKHVHLWKHUFPRUWLPHVWKHVL]HRIWKHQRUPDO
SUR[LPDODUWHU\3$$VRFFXUPXFKPRUHIUHTXHQWO\LQPHQWKDQLQZRPHQUHSRUWVUDQJHIURP
DSSUR[LPDWHO\RQHZRPDQWRHYHU\ILIWHHQPHQWRRQHZRPDQWRHYHU\WKLUW\PHQ>@
3$$LQFLGHQFHLQFUHDVHVZLWKDJHDQGDSSUR[LPDWHO\RQHKDOIRI3$$VDUHELODWHUDO>@
6WXGLHVKDYHUHSRUWHGWKDWDQDEGRPLQDODRUWLFDQHXU\VP$$$LVIRXQGLQWRRI3$$
SDWLHQWV>@DQGDERXWWKHVDPHSURSRUWLRQKDYHK\SHUWHQVLRQ>@
7KHSULPDU\ULVNRI3$$LVJHQHUDWLQJWKURPERHPEROLWKDWFDQRFFOXGHGRZQVWUHDP
YDVFXODWXUHDQGFRPSURPLVHORZHUOLPEWLVVXHOHDGLQJWRDFXWHOLPELVFKHPLD>@$FXWH
OLPELVFKHPLDLVRIWHQWKHILUVWSUHVHQWLQJV\PSWRPLQSDWLHQWVZLWK3$$:KHQD3$$LV
GHWHFWHGDQGWUHDWHGZLWKPHGLFDOPDQDJHPHQWFRPSOLFDWLRQUDWHVDUHKLJKDWRQH
\HDUDWILYH\HDUV>@6WXGLHVKDYHVXJJHVWHGWKDWWKHULVNRIFRPSOLFDWLRQLV
JUHDWHVWLQDQHXU\VPVODUJHUWKDQFPEXWWKDWHYHQVPDOOHUDQHXU\VPVZLWKPXUDOWKURPEXV
FDQOHDGWRGLVWDOHPEROL]DWLRQ>@
'HSHQGLQJRQWKHDQHXU\VPV\PSWRPVPD\LQFOXGHORFDOSDLQVZHOOLQJRUVHYHUHSXOVDWLRQ
EXWWKHPRVWIUHTXHQWDQGVHYHUHV\PSWRPVRI3$$DUHWKURPERHPEROLVPDQGWKURPERVLV
ZKLFKFDQOHDGWRFODXGLFDWLRQDFXWHOLPELVFKHPLDDQGPDMRUDPSXWDWLRQ6\PSWRPDWLF3$$V
LHFODXGLFDQWRULVFKHPLFOLPEDFFRXQWIRUDSSUR[LPDWHO\RIGLDJQRVHG3$$VDQGFDUU\
DULVNRIPDMRUDPSXWDWLRQDVKLJKDV>@7KHULVNRIWKURPERHPEROLF
FRPSOLFDWLRQVLQXQWUHDWHGDV\PSWRPDWLF3$$UDQJHVIURPDWRQH\HDUWRDWILYH
\HDUV>@$OWKRXJK3$$VH[SDQGDWDJURZWKUDWHRIDURXQGSHU\HDU>@UXSWXUHLV
UDUHZLWKDQDQQXDORFFXUUHQFHUDWHRI>@
'XSOH[XOWUDVRXQGLVWKHPRVWXVHIXOWHVWWRFRQILUPWKHGLDJQRVLVRI3$$VDQGFDQDOVR
DFFXUDWHO\PHDVXUHWKHVL]HRIWKHDQHXU\VPGRFXPHQWWKURPERVLVLQFOXGLQJLQWUDOXPLQDO
WKURPEXVDQGDVVHVVIRUFRPSUHVVLRQRIDGMDFHQWYHLQV'XSOH[XOWUDVRXQGFDQEH
VXSSOHPHQWHGZLWKFRPSXWHGWRPRJUDSK\RUFRQYHQWLRQDODUWHULRJUDSK\LIVXUJHU\LVSODQQHG
7KHJRDORI3$$UHSDLULVWRH[FOXGHWKHSRSOLWHDODQHXU\VPDQGPDLQWDLQRUUHHVWDEOLVK
DUWHULDOGRZQVWUHDPLQIORZ>@7KHUHLVJHQHUDOFRQVHQVXVWKDWDOOV\PSWRPDWLF3$$VVKRXOG
EHUHSDLUHGUHJDUGOHVVRIVL]HDQGDV\PSWRPDWLF3$$VDUHUHFRPPHQGHGWREHWUHDWHGLIWKH
DQHXU\VPGLDPHWHULVJUHDWHUWKDQFPPXUDOWKURPEXVLVSUHVHQWRUWKHSDWLHQWKDVSRRU
UXQRII>@

 +LVWRULFDO7UHDWPHQWV
7KHFXUUHQWJROGVWDQGDUGRI3$$UHSDLULVVDSKHQRXVYHLQE\SDVVJUDIWLQJZLWKHLWKHUOLJDWLRQ
PRVWFRPPRQRUHQGRDQHXU\VPRUUKDSK\UHVHFWLRQRIWKHDQHXU\VP>@:KHQOLJDWLRQ
LVXVHGXSWRDWKLUGRIE\SDVVHGDQHXU\VPVPD\FRQWLQXHWRHQODUJHGXHWRWKHSUHVHQFHRI
JHQLFXODWHDUWHULHVWKDWIHHGWKHDQHXU\VP>@9HLQE\SDVVLVJHQHUDOO\XVHGLQWKH
PDMRULW\RISDWLHQWV>@
:KHQQRVXLWDEOHYHLQFRQGXLWLVDYDLODEOHH[SDQGHGSRO\WHWUDIOXRURHWK\OHQHH37)(JUDIWV
DUHW\SLFDOO\XVHGZLWKUHSRUWHGSULPDU\SDWHQFLHVXSWRORZHUWKDQYHLQE\SDVVDWILYH

*25(9,$%$+1(QGRSURVWKHVLV 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 


CONFIDENTIAL INFORMATION                         
0'3URWRFRO7HPSODWH
5HYLVLRQ
'RF7\SH*&

RI
 6HFRQGDU\2EMHFWLYHV
7KHVHFRQGDU\REMHFWLYHVRIWKH*25(9,$%$+1(QGRSURVWKHVLV3RSOLWHDO$UWHU\
$QHXU\VPVWXG\DUHWRGRFXPHQWORQJWHUPWKURXJKPRQWKVVDIHW\DQGSHUIRUPDQFHE\
HYDOXDWLQJIUHHGRPIURPOLPEORVVOHQJWKRIKRVSLWDOVWD\DIWHUVWXG\SURFHGXUHOHQJWKRI
VWXG\SURFHGXUHVHULRXVDGYHUVHHYHQWV6$(VGHYLFHRUSURFHGXUHUHODWHGDGYHUVHHYHQWV
$(VWHFKQLFDOVXFFHVVSULPDU\SDWHQF\SULPDU\DVVLVWHGSDWHQF\VHFRQGDU\SDWHQF\DQG
IUHHGRPUHSHDWLQWHUYHQWLRQ,QDGGLWLRQOLVWLQJVRIGHYLFHPLJUDWLRQHQGROHDNGHYLFHIUDFWXUH
DQGVWXG\OLPEDPSXWDWLRQZLOOEHUHSRUWHGVHSDUDWHO\


6WXG\'HVLJQ
 6WXG\'HVLJQ6FKHPD
7KHVWXG\GHVLJQLVGHSLFWHGLQ)LJXUHEHORZ

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1 
Doc Type: GC 
 
8 of 30 
 
 
Verify Patient Previously Received a GORE® 
VIABAHN® Endoprosthesis for the Treatment of 
a PAA since  September 15, 2012 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion / Exclusion Criteria from Patient Records 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient Fails to Meet Inclusion / Exclusion Criteria 
 
Patient Meets Study Criteria 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Obtain informed consent (consecutive enrollment, 
starting with the first treated patient) 
 
Patient 
declines 
participation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Collect Medical History, Pre-Procedure 
Assessments, Procedural Information, Angiographic 
Results, SAEs and device or procedure related AEs. 
 
 
 
 
 
 
 
 
Patient is a Screening Failure 
or refused participation. 
Record on a Screen Failure 
Log and completion of a ”Not 
Included Patient CRF”. 
Summary will be provided 
 
 
 
   
        
 
 
Record Discharge Evaluation Information: 
Collection of SAEs, device or procedure related AEs, 
Antiplatelet / Anticoagulant Medications, Clinical Assessments 
and Color Flow Duplex Ultrasound (as available) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Record Any Retrospective Follow-Up Through 12 months (+/- 3 
months): 
Collection of SAEs, device or procedure related AEs, 
Antiplatelet / Anticoagulant Medications, Clinical Assessments, 
Repeat Interventions and Color Flow Duplex (as available) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Continue to Follow-Up patients Through 24 and 36 months: 
Collection of SAEs, device or procedure related AEs, 
Antiplatelet / Anticoagulant Medications, Clinical Assessments, 
Repeat Interventions and Color Flow Duplex (as available) 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 3.  Study Design Schema 
 

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1 
Doc Type: GC 
 
9 of 30 
3.2. Description of Study Design 
This is a retrospective, multicenter, non-randomized single-arm clinical study with a 
prospective follow-up to evaluate the safety and performance of the GORE® VIABAHN® 
Endoprosthesis for the treatment of patients with PAAs. All patients will have received the 
GORE® VIABAHN® Endoprosthesis for treatment of a PAA since September 15, 2012 (date at 
which reimbursement for the GORE®VIABAHN® device was received in France). Inclusion for 
all patients will be retrospective, follow-up visit(s) can be prospective.    
A maximum of 10 Clinical Investigative Sites (referred to as “Sites” in the remainder of this 
document) in France will participate in this study. 50 patients with an adequate follow-up to 
assess primary endpoints will be enrolled. All patients will have received the GORE® 
VIABAHN® Endoprosthesis for treatment of a PAA since 15 September 2012 and meet all of 
the inclusion and none of the exclusion criteria as specified in Sections 4.2 and 4.3 of this 
protocol.  
Data entry will be monitored and enrollment will be stopped when 50 subjects have data for 
the 12 months follow-up visit entered.  
Patients with bilateral PAAs treated with GORE® VIABAHN® Endoprosthesis at different dates 
can be enrolled in the study. The first limb enrolled will be considered the study limb. Patients 
with both limbs treated within the same procedure will not be enrolled in the study.  
Follow-up examinations through 12 months (+/- 3 months) post-implant will be collected for the 
primary endpoint analysis. This will include clinical assessment, imaging-based evaluations, 
SAEs, device, and procedure related AEs. Patients will be further followed through 24 and 36 
months post-procedure. 
 
3.3. Study Endpoints 
3.3.1. 
Definitions 
Acute Limb Ischemia[55]: Defined by the operating or treating physician. Typically defined as 
emergently threatened, whether marginally or immediately, implying reversible ischemia in a 
limb that is salvageable without a major amputation if arterial obstruction is relieved quickly or 
irreversible ischemic change requiring major amputation. 
Adverse Event (AE): Any untoward medical occurrences, unintended disease or injury or any 
untoward clinical signs (including abnormal laboratory findings) in patients, users or other 
persons related to the investigational medical device or procedure.[56] For this study, only 
device or procedure related AEs need to be reported. 
Device Fracture: A stent fracture was defined as any discontinuity of the normal structure of 
the stent as diagnosed on x-ray. 
Endoleak (Modified from White et al.)[57]: 
Type I – Present when a persistent perigraft channel of blood flow develops due to 
inadequate or ineffective seal at the graft ends.  
Type II – Occurs when there is persistent collateral blood flow into the aneurysm sac 
flowing retrogradely from collateral branches. 
Type III – Arises at the mid-graft region due to leakage through a defect in the graft fabric 
or between the segments of multiple grafts.  

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1 
Doc Type: GC 
 
10 of 30 
Type IV –Blood diffusion across the pores of the graft fabric or through tiny holes in the 
graft fabric caused by sutures or stent struts.   
Type V - Leakage from an unknown origin.  
Hinge Point: Located at the adductor tubercle, which corresponds to the upper border of the 
patella, in a plane perpendicular to the femoral axis. 
Length of Hospital Stay: The number of days the subject remains in the hospital due to 
endovascular repair of a PAA with VIABAHN (“index procedure”). 
Length of Procedure: The number of minutes the subject remains in the operating room or 
catheterization laboratory due to endovascular repair of a PAA. If no specific information is 
available the first and last angiographic timestamp can be used to capture the length of the 
procedure. 
Limb Loss: An amputation on the study limb above the metatarsals. 
Migration: Any post-operative device migration requiring treatment. 
Patency: 
Primary Patency: Blood flow without occlusion maintained through the device after 
implant without an intervention. 
Primary Assisted Patency: Blood flow maintained through the device after implant 
regardless of re-interventions performed (without occlusion). 
Secondary Patency: Blood flow through the device regardless of re-interventions 
performed (with or without occlusion) and freedom from surgical bypass. 
Re-intervention: Endovascular or surgical procedure performed to treat a stenosis or 
occlusion within the study device(s) or within 5 mm of the proximal or distal edge of the 
device(s), treatment of endoleaks or other reasons. 
Serious Adverse Event (SAE)[56]: An AE that led to death or lead to serious deterioration in 
the health of the subject that resulted in a life threatening illness or injury, or a permanent 
impairment of a body structure of body function, or in-patient or prolonged hospitalization, or a 
medical or surgical intervention to prevent life-threatening illness or injury, or permanent 
impairment to a body structure or a body function.  
Technical Success: Successful aneurysmal exclusion using the GORE® VIABAHN® 
Endoprosthesis at time of the procedure without Type I or III endoleaks that require post-
procedure intervention within 30 days. 
3.3.2. 
Primary Endpoints  
The primary performance endpoint for this trial is: 
• 
Primary patency at 12 months. 
The primary safety endpoint for this trial is: 
• 
Serious adverse events and adverse events related to the study procedure or the 
study device at 12 months. 
3.3.3. 
Secondary Endpoints  
The secondary endpoints for this trial are:  
• 
Technical success; 
• 
Freedom from limb loss on the study limb at 12, 24 & 36 months; 

*25(9,$%$+1(QGRSURVWKHVLV 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 


CONFIDENTIAL INFORMATION                         
0'3URWRFRO7HPSODWH
5HYLVLRQ
'RF7\SH*&

RI
x
)UHHGRPIURPUHSHDWLQWHUYHQWLRQDW	PRQWKV
x
/HQJWKRISURFHGXUDOKRVSLWDOVWD\LQGD\V
x
/HQJWKRISURFHGXUHLQPLQXWHV
x
6HULRXVDGYHUVHHYHQWVDQGDGYHUVHHYHQWVUHODWHGWRWKHVWXG\SURFHGXUHRU
VWXG\GHYLFHDW	PRQWKV
x
3ULPDU\SDWHQF\DW	PRQWKV
x
3ULPDU\DVVLVWHGSDWHQF\DW	PRQWKV
x
6HFRQGDU\SDWHQF\DW	PRQWKV

/LVWLQJV
/LVWLQJVRIWKHIROORZLQJUHSRUWHGHYHQWVZLOOEHSURYLGHG
$OO(QGROHDNV
'HYLFH0LJUDWLRQ
'HYLFH)UDFWXUH
0DMRUDPSXWDWLRQRQWKHVWXG\OLPE
0LQRUDPSXWDWLRQRQWKHVWXG\OLPE


6WXG\3RSXODWLRQ
 'HVFULSWLRQRI3RSXODWLRQ
7KHVWXG\SRSXODWLRQLQFOXGHVSDWLHQWVZLWKDV\PSWRPDWLFDQHXU\VPRUDV\PSWRPDWLF
DQHXU\VPFPGLDPHWHURIWKHSRSOLWHDODUWHU\RUSUHVHQFHRIPXUDOWKURPEXVFPLQ
WKHSRSOLWHDODUWHU\$OOSDWLHQWVWUHDWHGSHU,)8ZLWKWKH*25(9,$%$+1(QGRSURVWKHVLV
VLQFH6HSWHPEHUGDWHRIUHLPEXUVHPHQWLQ)UDQFHZLOOEHVFUHHQHGFRQVHFXWLYHO\
VWDUWLQJZLWKILUVWWUHDWHGSDWLHQW
 ,QFOXVLRQ&ULWHULD
,QFOXVLRQWRWKHVWXG\UHTXLUHVWKHSDWLHQW
 5HFHLYHGD*25(9,$%$+1(QGRSURVWKHVLVWRWUHDWDSRSOLWHDODUWHU\DQHXU\VP
 +DGDV\PSWRPDWLFDQHXU\VPRUDV\PSWRPDWLFDQHXU\VPFPGLDPHWHURIWKH
SRSOLWHDODUWHU\RUWKHSUHVHQFHRIPXUDOWKURPEXVFPLQWKHSRSOLWHDODUWHU\
 :DV\HDUVRIDJHRUROGHUDWWKHWLPHRIWKHWUHDWPHQW
 +DGDQHOHFWLYHSRSOLWHDODUWHU\DQHXU\VPSURFHGXUH
 +DVSURYLGHG,QIRUPHG&RQVHQWSHUVRQDOO\RUWKURXJKODZIXOUHSUHVHQWDWLRQDV
GHWHUPLQHGE\DSSOLFDEOHORFDOUHJXODWLRQVDQGVWDWHODZ6HFWLRQ
 ([FOXVLRQ&ULWHULD
3ULRUWRRUDWWKHWLPHRILPSODQWWKHSDWLHQWLVKDV
 %LODWHUDOSRSOLWHDODUWHU\DQHXU\VPVZLWKLQLWLDOWUHDWPHQWRQWKHVDPHGD\
 7KURPERWLFRFFOXVLRQRIWKHSRSOLWHDODUWHU\RU3$$
 0DUIDQV\QGURPHRU(KOHUV'DQORVV\QGURPH
 8QDEOHWRWROHUDWHDQWLSODWHOHWWKHUDS\
 7KURPERSKLOLDUHTXLULQJORQJWHUPDQWLFRDJXODWLRQ
 .QRZQDOOHUJLHVWRWKH*25(9,$%$+1(QGRSURVWKHVLVFRPSRQHQWV

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1 
Doc Type: GC 
 
12 of 30 
7. Enrolled in another investigational drug or medical device trial where participation may 
have affected the outcome or treatment of the subject in the popliteal artery aneurysm 
study with the GORE® VIABAHN® Endoprosthesis or had previous surgery for the 
popliteal artery aneurysm in the study limb. 
4.4. Patient selection 
For this Post-market study it has been decided that the screening of the patient records will 
start with patients treated September 15, 2012 and continuously go forward. 
At each Site the Principal Investigator and his team will confirm in- and exclusion criteria for 
each patient and will contact the patient to obtain his agreement to collect medical data: 
a. If the patient meets the criteria and gives his agreement to participate he will be 
considered as enrolled. 
b. If the patient does not agree to participate or fails to meet the Inclusion / Exclusion 
criteria he will be considered as a screening failure and the reason will be 
documented in the Not Included Patient CRF. 
c. If the patient does not respond after three call attempts he will be considered as 
lost to follow-up and this will be documented in the Not Included Patient CRF.  
d. If the PI and his team are informed by the family during one of this calls that the 
patient previously died in another hospital they will inquire the reason and the date 
of the death. This will be registered in the Not Included Patient CRF. If the family 
refuses to give details only the death will be registered in the Not Included Patient 
CRF but no more details. 
In case the PI and his team have clinical information available that patient died in their 
hospital cause and date of death will be registered and the Not Included Patient CRF will 
be completed.  
 
 

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1 
Doc Type: GC 
 
14 of 30 
5.4. Enrollment   
Patients are considered enrolled if they have met all of the inclusion criteria (Section 4.2) and 
none of the exclusion criteria (Section 4.3) and have signed the patient information and 
consent form. Any patient not meeting all of the inclusion criteria and none of the exclusion 
criteria should be recorded on a screening failure log along with the reason for failure, in 
addition a screen-failure CRF will be completed. A summary of screen failures including the 
following information: subject number, date of procedure, and reason for failure will be 
reported.   
Enrollment will be performed in consecutive order beginning with the first patient treated since 
September 15, 2012. Patients with bilateral PAAs treated with GORE® VIABAHN® 
Endoprosthesis at different dates can be enrolled in the study. The first limb enrolled will be 
considered the study limb.  Bilateral patients with initial treatment on the same day will not be 
enrolled. The number of included patients will be monitored via entries in the electronic CRF 
and Sites will be informed when the inclusion goal (50 patients with data for the 12 month 
follow-up visit) is met. 
5.5. Procedure 
As part of the retrospective study the subject previously received the study device. Procedural 
information related to placement of the device(s) such as overlap, oversizing, number of 
devices, landing zone, post-deployment dilatation, SAEs, and AEs related to the initial study 
procedure or the study device will be recorded on the Case Report Forms (CRFs), as 
available.    
5.6. Repeat Interventions 
Repeat interventions may take place prior to or after hospital discharge. Procedures taking 
place during the study procedure should not be captured as repeat intervention. Any available 
procedural data and angiographic or ultrasound data related to these repeated interventions 
should be recorded in the CRFs.    
5.7. Follow-Up 
Follow-up visits need to be done in a window of +/- 90 days in order to be documented as 
study visits. This means that 12 month follow-up visit needs to take place between 275 and 
455 days post-procedure, the 24 months follow-up visit between 640 and 820 days post-
procedure, and the 36 month follow-up visit between 1005 and 1185 days post-procedure. All 
visits occurring from the time of procedure through 1185 days post-procedure should be 
recorded for each subject. If a subject had an office visit between 1005-1185 (three years + 
90) days post-procedure, then no further information will be collected on the subject after 1185 
days. Device or procedure related AEs, antiplatelet / anticoagulant medications, clinical 
assessment, ultrasound, and angiographic information should be collected, during each follow-
up visit as applicable and available. 
5.7.1. 
SAEs and device or procedure related AEs 
SAES and device or procedure related AEs found in the subject chart should be 
recorded at each follow-up visit. Additional details regarding AE recording can be 
found in Section 9. 
 
 

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1 
Doc Type: GC 
 
15 of 30 
5.7.2. 
Medications 
Medications being recorded for this study include post-procedural antiplatelet and 
anticoagulation medications. Start date, end date, dose, and frequency should be 
recorded for each subject. Medications used during the procedure such as 
intravenous Heparin do not need to be recorded.   
5.7.3. 
Clinical Assessment 
Clinical Assessments include the presence of palpable pedal pulses and an Ankle 
Brachial Index (ABI). The ABI of each subject should be recorded. A Toe Brachial 
Index may not be used in place of an ABI.  
5.7.4. 
Color Flow Duplex Ultrasound 
When possible Color Flow Duplex Ultrasound information should be recorded for 
each subject at each study visit; verification of the presence or absence of blood flow 
should be recorded. Additionally, aneurysmal dimensions will be evaluated. 
5.8. Subject Withdrawal from the Clinical Study 
All patients have the right to withdraw themselves from participation at any point during the 
study. In addition, Principal Investigators also have the authorization to terminate a subject’s 
participation in the study. 
A description of the reason for the subject’s termination will be documented. Reasons for 
termination include: completion of study, subject’s voluntary withdrawal, physician-directed 
subject withdrawal, and death.  
Upon study exit the subject will be followed per standard of care by Investigator and / or 
another physician. 
5.9. Subject Study Completion 
A subject has completed the study when 36 months (1185 days or 3x365 + 90 days) of follow-
up data has been recorded on the CRFs. Any subject that does not complete these 
requirements due to voluntary withdrawal, death, lost secondary patency (e.g. had a study 
limb bypass) or any other reason will be considered a withdrawal and the reason for 
discontinuation will be marked on the CRF.   
If a subject is lost to follow-up, the appropriate CRF must be completed as soon as possible 
after subject status has been determined. If a subject fails to comply with follow-up 
evaluations, the Site must make at least three attempts to contact the patient and his family 
and potentially his General Practitioner. Each attempt to contact the subject and the method 
used (e.g., telephone contact, registered letter) must be documented in the subject’s records.  
5.10. Device Deficiencies 
Device deficiencies are defined as inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. The process for reporting device 
deficiencies should be done through normal product surveillance mechanisms. 
5.11. Explant Procedures 
The GORE® VIABAHN® Endoprosthesis may be explanted during a surgical procedure or as 
part of an autopsy. If the explanted study device is available, Sites are requested to return the 
explanted device to the Sponsor for gross and histological evaluation. Contact the Gore 
Associate managing the study to facilitate shipment of a specimen shipping kit. The specimen 

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1 
Doc Type: GC 
 
17 of 30 
6.3. Device Accountability and Storage  
The GORE® VIABAHN® Endoprosthesis is a commercially available product and has already 
been used, so accountability or storage for this study is not required. The lot and serial number 
for each commercial device used in the study will be recorded in the subject records and 
transcribed to the CRF.   
6.4. Protocol Deviations 
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. The Investigator is 
responsible for promptly reporting protocol deviations to 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 and / or Site termination.    
6.5. Protocol Amendments 
The Sponsor will obtain CCTIRS and CNIL approval before starting collecting the data; on all 
amendments will also be submitted in a timely manner to the CCTIRS and to CNIL. The 
Sponsor will ensure proper training of Investigator and Site staff on all protocol amendments. 
6.6. 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 and source data available 
for inspection by the Sponsor, MedPass monitors, CCTIRS, CNIL, and other regulatory 
authorities. 
6.7. Study Records Retention  
All data shall be produced and maintained in a way that assures control and traceability.  
Source documents are required for each subject enrolled. 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 15 
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. Where copies of the original source document as well as 
printouts of original electronic source documents are retained, these shall be signed and dated 
by a member of the investigational Site team with a statement that it is a true reproduction of 
the original source document.   
 
Investigator records will include, but not be limited to:  
o All correspondence with another Investigator, CCTIRS, CNIL, the Sponsor, a monitor, 
including required reports. 
o Records of each subject’s case history and exposure to the device. Case histories include 
the CRFs and supporting data, medical records, including, for example, progress notes of 
the physician, the individual’s hospital chart(s), and the nurses’ notes.  Such records shall 
include: 
 
All relevant observations, including records concerning AEs, the information, date 
and condition of each subject upon entering the trial, information about relevant 
previous medical history, and the results of all diagnostic tests. 

*25(9,$%$+1(QGRSURVWKHVLV 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 


CONFIDENTIAL INFORMATION                         
0'3URWRFRO7HPSODWH
5HYLVLRQ
'RF7\SH*&

RI
7KLVVWXG\GRHVQRWOHDGWRDQ\FKDQJHLQSDWLHQWPDQDJHPHQWDQGSDWLHQWVZLOOUHFHLYHWKH
VDPHWUHDWPHQWDVWKH\ZRXOGKDYHUHFHLYHGLIWKH\KDGGHFLGHGQRWWRSDUWLFLSDWH7KHUHIRUH
WKHUHLVQHLWKHUDQDGGLWLRQDOULVNQRUDGLUHFWEHQHILWUHODWHGWRWKHSDUWLFLSDWLRQLQWKHVWXG\

$GYHUVH(YHQWVDQG6DIHW\0RQLWRULQJ
$(VDUHGHILQHGDVDQ\XQWRZDUGPHGLFDORFFXUUHQFHVXQLQWHQGHGGLVHDVHRULQMXU\RUDQ\
XQWRZDUGFOLQLFDOVLJQVLQFOXGLQJDEQRUPDOODERUDWRU\ILQGLQJVLQSDWLHQWVXVHUVRURWKHUSHUVRQV
ZKHWKHURUQRWUHODWHGWRWKHLQYHVWLJDWLRQDOPHGLFDOGHYLFH>@$FFRUGLQJWRWKHSULPDU\DQG
VHFRQGDU\HQGSRLQWVRIWKLVVWXG\WKHGRFXPHQWDWLRQRIDGYHUVHHYHQWVZLOOFRQFHUQDOOVHULRXV
DGYHUVHHYHQWVDQGDGYHUVHHYHQWVUHODWHGWRWKHLQLWLDOVWXG\SURFHGXUHRUWKHVWXG\GHYLFH
UHJDUGOHVVRIWKHVHYHULW\WKURXJKRXWPRQWKV
 $QWLFLSDWHG$GYHUVH(YHQWV
$QWLFLSDWHG$(VDUHFRPSOLFDWLRQVWKDWDUHNQRZQWREHDVVRFLDWHGZLWKSDWLHQWVXQGHUJRLQJ
HQGRYDVFXODU3$$UHSDLU6HH6HFWLRQ5LVN$VVHVVPHQW$GGLWLRQDO$(VPD\LQFOXGH
FOLQLFDOVHTXHODHDVVRFLDWHGZLWKDPSXWDWLRQDQHXU\VPHQODUJHPHQWHGHPDGHKLVFHQFH
YDVFXODUVSDVPYDVFXODUWUDXPDFRDJXORSDWK\FODXGLFDWLRQFOLQLFDOVHTXHODHDVVRFLDWHG
ZLWKGHYLFHIUDFWXUHVWURNHQRQLPSURYLQJZRXQGDOOHUJLFUHDFWLRQWRWKHGHYLFHRURWKHU
FRPSRQHQWVRUSHUIRUDWLRQRIWKHYHVVHO

$GYHUVH(YHQW5HODWLRQVKLS
(DFKUHSRUWHG$(ZLOOEHDVVHVVHGE\WKH,QYHVWLJDWRUIRULWVSULPDU\VXVSHFWHG
UHODWLRQVKLSWRWKHGHYLFHRUSURFHGXUH
2QO\RQHSULPDU\UHODWLRQVKLSZLOOEHDVVLJQHGWRHDFKUHSRUWHG$(7KHUHODWLRQVKLSV
LQFOXGH6WXG\'HYLFH5HODWHG6WXG\3URFHGXUH5HODWHG1RW5HODWHGRUDQ8QNQRZQ
5HODWLRQVKLS5HODWLRQVKLSGHVFULSWLRQVDUHSURYLGHGEHORZ
x
6WXG\'HYLFH5HODWHG7KHIXQFWLRQLQJRUFKDUDFWHULVWLFVRIWKHVWXG\
GHYLFHFDXVHGRUFRQWULEXWHGWRWKH$(
x
6WXG\3URFHGXUH5HODWHG7KHLQLWLDOVWXG\SURFHGXUHDQGQRWWKHGHYLFH
FDXVHGRUVLJQLILFDQWO\FRQWULEXWHGWRWKH$(
x
1RW5HODWHG$Q$(ZKLFKFDQQRWEHDWWULEXWHGWRWKHVWXG\GHYLFHRULQLWLDO
VWXG\SURFHGXUH
x
8QNQRZQ5HODWLRQVKLS7KHUHODWLRQVKLSRIWKH$(WRWKHGHYLFHRU
SURFHGXUHFDQQRWEHGHWHUPLQHG

$GYHUVH(YHQW&ODVVLILFDWLRQ
(DFK$(ZLOOEHDVVHVVHGE\WKH,QYHVWLJDWRUWRGHWHUPLQHLILWLVVHULRXVRUQRQ
VHULRXV
6HULRXV$GYHUVH(YHQW,62'HILQLWLRQ>@
$6$(LVDQ$(WKDW
x
OHGWRGHDWK
x
OHGWRVHULRXVGHWHULRUDWLRQLQWKHKHDOWKRIWKHVXEMHFWWKDWHLWKHUUHVXOWHGLQ
R DOLIHWKUHDWHQLQJLOOQHVVRULQMXU\RU
R DSHUPDQHQWLPSDLUPHQWRIDERG\VWUXFWXUHRUERG\IXQFWLRQRU
R LQSDWLHQWRUSURORQJHGKRVSLWDOL]DWLRQRU

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1 
Doc Type: GC 
 
22 of 30 
o medical or surgical intervention to prevent life threatening illness or 
injury or permanent impairment to a body structure or a body function 
• 
led to fetal distress, fetal death or a congenital abnormality or birth defect.  
 
SAEs include device deficiencies that might have led to a SAE if suitable action had 
not been taken or if an intervention had not been made or if circumstances had been 
less fortunate. Any planned hospitalization for pre-existing conditions, without serious 
deterioration in health, is not considered a SAE. 
9.1.3. 
Adverse Event Reporting and Coding 
AEs will be reported on the appropriate 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 Investigator shall supply the 
Sponsor with any additional requested information. 
Timely and complete reporting of safety information assists the Sponsor in identifying 
any untoward medical occurrence, thereby allowing: (1) protection of safety of study 
patients; (2) a greater understanding of the overall safety profile of the GORE® 
VIABAHN® Endoprosthesis; (3) appropriate modification of study protocols; and (4) 
adherence to worldwide regulatory requirements. 
The following information should be collected for each reported AE: 
• 
AE Name 
• 
AE Onset Date 
• 
Relationship 
• 
Classification (serious / non-serious) 
• 
Treatment 
• 
Outcome 
• 
Resolution Date 
 
All reported AEs will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA). 
In reporting AEs the following submission guidelines should be followed: 
• 
AE reporting begins once the subject has received a GORE® VIABAHN® 
Endoprosthesis and continues until study completion / discontinuation.   
o NOTE: Any AE that occurs while the subject is in the operating room / 
catheterization laboratory should not be recorded as an AE, unless it is 
unresolved when the subject leaves the operating room / catheterization 
laboratory. 
o NOTE: Any AE occurring after the final study visit will not be recorded in this 
study. 
• 
AEs with an outcome status of “Ongoing” should be assessed at each follow-up 
evaluation to determine if the event has resolved. AEs ongoing at study 
completion / discontinuation should be left as “Ongoing” on the AE CRF.   

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1 
Doc Type: GC 
 
23 of 30 
• 
Clinical sequelae present at baseline should be recorded on the Medical History 
CRF. If the clinical sequela increases in severity or frequency from baseline then 
it should be reported as an AE. 
• 
If known, the diagnosis of the underlying illness or disorder should be recorded, 
rather than its individual symptoms. If unable to provide a diagnosis, report the 
symptoms as separate events. AEs should be reported using the full name 
without abbreviations or narratives. 
• 
If an event increases in severity (goes from a non-serious to a serious adverse 
event) then a stop date for the non-serious event should be provided and a new 
event with increased severity should be recorded. 
• 
Subject death is not considered an AE. (See Section 9.1.4) 
• 
A device fracture is not an AE but the clinical sequelae associated with the 
fracture should be recorded as an AE. 
• 
PAA enlargement is an AE if it grows by more than 10 mm from the baseline 
measurement. 
• 
Endoleaks 
o For type I, II and III endoleaks the possible relationship to the procedure or 
device will be based on the Investigators assessment as described in Section 
9.1.1. 
o Type IV endoleaks should be considered related to the study device 
regardless of when the endoleak occurs.   
o Type V endoleaks should be classified as an unknown relationship. 
All endoleaks should be reported as Adverse Events and the respective CRF pages 
need to be completed. 
9.1.4. 
Subject Death 
Death is not an AE but instead an outcome of an AE. In rare cases the known cause 
of death or one specific AE responsible for death may not be able to be declared as 
the major contributor to death. When possible, death should be an outcome and the 
underlying cause of the death recorded as an AE (e.g. cardiac arrest).   
Any ongoing AE at the time of death will be indicated as ongoing on the CRF unless it 
is the single event that resulted in death of the subject. 
9.2. Unanticipated Adverse Device Effects (UADE)  
An 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.”[59]  
The Sponsor is required to notify FDA and French Health Authorities (Agence Nationale de 
Sécurité du Médicament et des Produits de Santé (ANSM)) of any UADE. Therefore, 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 subject, 
the Site should immediately notify the Sponsor. 

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1 
Doc Type: GC 
 
25 of 30 
Data from all study Sites will be pooled on a clinical basis, i.e., the study Sites will 
follow a common protocol, the study will be monitored to assure compliance with the 
protocol and applicable government regulations, and the data collection and handling 
procedures will be the same at all study Sites.   
10.3.4. Primary Endpoints 
Performance will be evaluated by primary patency at 12 months of the GORE® 
VIABAHN® Endoprosthesis in the treatment of Popliteal Artery Aneurysms. A point 
estimate will be calculated requiring primary patency at the one year visit to be 
declared a success. Having loss of primary patency at day 365 will be tabulated as a 
failure. Primary patency is defined in section 3.3.1.  
Safety of the GORE® VIABAHN® Endoprosthesis will be assessed through 12 
months by evaluation of serious adverse events (SAEs) and adverse events related 
to the study procedure or the study device. Counts will be tabulated at 12 months. 
10.3.5. Secondary Endpoint(s) 
Primary patency, which is defined as blood flow maintained through the device 
without an intervention. Blood flow should be determined at the follow-up visits, by 
either angiography or color-coded duplex sonography.  In the event that duplex 
sonography is not obtained, blood flow will be assessed by clinician exam.  Primary 
patency at 12, 24, & 36 months after implant will be estimated through time-to-event 
analysis.  
Serious adverse events and adverse events relative to the study device and 
procedure will be obtained through 36 months for assessment of the device safety.  
Counts will be tabled at 24, & 36 months.  
Length of hospital stay will be measured in calendar days. Length of hospital stay 
will be calculated omitting all patients with unknown endpoint status. 
Length of procedure will be measured in minutes. Length of procedure will be 
calculated omitting all patients with unknown endpoint status.  
Primary assisted patency at 12, 24, & 36 months after implant will be estimated 
through time-to-event analysis. Blood flow should be determined by angiography or 
color-coded duplex sonography. In the event that duplex sonography is not obtained, 
blood flow will be assessed by clinician exam. 
Freedom from limb loss of the study limb at 12, 24, & 36 months after implant will 
be estimated through time-to-event analysis. 
Freedom from repeat intervention at 12, 24, & 36 months after implant will be 
estimated through time-to-event analysis. 
Secondary patency at 12, 24, & 36 months after implant will be estimated through 
time-to-event analysis. Blood flow should be determined by angiography or color-
coded duplex sonography. In the event that duplex sonography is not obtained, blood 
flow will be assessed by clinician exam.  
Technical Success 
Technical success is defined as successful aneurysmal exclusion using the GORE® 
VIABAHN® Endoprosthesis at time of the procedure without Type I and III endoleaks 
that require post-procedure intervention within 30 days. All subjects without known 
status for this endpoint will be omitted in calculating this statistic.  

*25(9,$%$+1(QGRSURVWKHVLV 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 


CONFIDENTIAL INFORMATION                         
0'3URWRFRO7HPSODWH
5HYLVLRQ
'RF7\SH*&

RI
$GGLWLRQDOOLVWLQJV
,QDGGLWLRQOLVWLQJVRIWKHIROORZLQJHYHQWVZLOOEHSURYLGHGHQGROHDNPLJUDWLRQ
IUDFWXUHDQGDPSXWDWLRQ
&RQWURORI%LDV
%LDVZLOOEHFRQWUROOHGE\VWULFWDGKHUHQFHWRSDWLHQWHOLJLELOLW\FULWHULDDQGWRWKHVWXG\SURWRFRO
6LWHVZLOOEHPRQLWRUHGIRUFRPSOLDQFHZLWKVWXG\SURWRFROLQFOXGLQJVXEMHFWHOLJLELOLW\FULWHULD
DQGZLOOEHDXGLWHGIRUERWKFRPSOLDQFHZLWKWKHSURWRFRODQGIRUGDWDTXDOLW\
'DWD$QDO\VLV
$QDO\VLVZLOOEHSHUIRUPHGDIWHUDOORIWKHGDWDKDVEHHQREWDLQHGHQWHUHGFOHDQHGDQG
ORFNHGIRUWKHLQWHULPDVZHOODVWKHILQDODQDO\VHV
 (WKLFDODQG5HJXODWRU\&RQVLGHUDWLRQV
6WDWHPHQWRI&RPSOLDQFH
7KHVWXG\ZLOOEHFRQGXFWHGLQFRPSOLDQFHZLWKWKLVSURWRFRO,QWHUQDWLRQDO&RQIHUHQFHRQ,62
DQGDSSOLFDEOHUHJXODWRU\UHTXLUHPHQWVVHH7DEOHEHORZ

7DEOH$SSOLFDEOH5HJXODWLRQVIRUWKLV&OLQLFDO6WXG\
,&+*&3(
,QWHUQDWLRQDO&RQIHUHQFHRQ
+DUPRQLVDWLRQ5HJXODWLRQV
*XLGHOLQH)RU*RRG&OLQLFDO
3UDFWLFH
,62
&OLQLFDOLQYHVWLJDWLRQRIPHGLFDO
GHYLFHVIRUKXPDQSDWLHQWV±*RRG
FOLQLFDOSUDFWLFH
0HGLFDO'HYLFH'LUHFWLYH
((&
$UWLFOH$QQH[;
&RXQFLO'LUHFWLYH((&RI
-XQH
$PHQGPHQWWRWKH0''
(&
$UWLFOH$QQH[;
'LUHFWLYH(&RIWKH
(XURSHDQ3DUOLDPHQWDQGRIWKH
&RXQFLORI6HSWHPEHU

&RPSOLDQFH5HVSRQVLELOLWLHV
7KH6SRQVRUZLOOFRQGXFWWKHFOLQLFDOVWXG\LQDFFRUGDQFHZLWKDOODSSOLFDEOHUHJXODWLRQVDQG
ODZV7KH6SRQVRUZLOOEHUHVSRQVLEOHIRUGRFXPHQWLQJWKDW,QYHVWLJDWRUVKDYHWKHQHFHVVDU\
VNLOOVWUDLQLQJDQGLQIRUPDWLRQWRSURSHUO\FRQGXFWWKHFOLQLFDOVWXG\7KH6SRQVRUZLOOHQVXUH
SURSHUPRQLWRULQJRIWKHFOLQLFDOVWXG\DQGHQVXUHDSSURSULDWHDSSURYDOVZHUHREWDLQHGSULRUWR
HQUROOPHQW7KH6SRQVRUZLOOSURYLGHLQIRUPDWLRQWRWKH,QYHVWLJDWRUVFRQFHUQLQJWKHSURJUHVV
RIWKHFOLQLFDOVWXG\DQGDQ\QHZPDWHULDOLQIRUPDWLRQDERXWWKHFOLQLFDOVWXG\
7KH,QYHVWLJDWRUZLOOFRQGXFWWKHFOLQLFDOVWXG\LQDFFRUGDQFHZLWKDOODSSOLFDEOHUHJXODWLRQV
DQGODZVDQ\UHOHYDQWDJUHHPHQWVWKHVWXG\SURWRFRODQGDOODSSURYDOFRQGLWLRQVRIWKH
UHYLHZLQJ&RPPLWWHHV7KH,QYHVWLJDWRULVUHVSRQVLEOHIRUSURWHFWLQJWKHULJKWVVDIHW\DQG
ZHOIDUHRISDWLHQWVXQGHUKLVKHUFDUH
,QIRUPHG&RQVHQW

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1 
Doc Type: GC 
 
27 of 30 
It is the responsibility of the Investigator to give each patient prior to inclusion in the 
investigation, full and adequate verbal and written information about the objectives of the 
study. The patients must be informed about their right to withdraw from the investigation at any 
time and for any reason without sanction, penalty or loss of benefits to which they are 
otherwise entitled and that withdrawal from the investigation will not jeopardize their future 
medical care. Written Patient Information should be given to each patient before enrolment.   
In compliance with national regulatory requirements, the Patient Information Sheet and 
Informed Consent Form will be submitted to the CCTIRS and to CNIL to be compliant with 
their requirements. The Investigator will provide the original copy of the signed and dated 
informed consent to the subject and a copy will be maintained in the subject’s medical record. 
In addition, the signed and dated informed consent will be reviewed by the clinical monitor 
during the monitoring visit to ensure that it is properly executed in compliance with regulation. 
The Investigator, or his / her designee, must document in the subject’s medical record that 
informed consent was obtained prior to study participation. 
If applicable the Informed Consent will be updated or amended whenever new information 
becomes available that may be relevant to the patient and the patient advised of this 
information and re-consented. All modifications to the Informed Consent template must be 
approved by Gore prior to any submission and use.   
11.4. Conflict of Interest 
All Investigators will follow their Site’s conflict of interest policies.   
11.5. Confidentiality 
This research is subject to the law of January 6, 1978 relating to Data Protection, as amended 
and will be submitted to the French Advisory Committee on Information Processing in Material 
Research in the Field of Health (CCTIRS), and then the French Data Protection Agency 
(CNIL) before its actual commencement. 
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 other regulatory bodies. 
The Investigator will inform the patients that their records may be reviewed. 
11.6. Study Discontinuation or Suspension  
Gore reserves the right to terminate the investigation but intends only to exercise this right for 
valid scientific or administrative reasons and reasons related to protection of patients.  
Investigators will be notified in writing in the event of termination.  
In addition, Gore will consider terminating or suspending the participation of the investigative 
Site if monitoring identifies serious or repeated deviations related to this investigation. 
If the Sponsor prematurely discontinues the study, all enrolled patients will be informed and 
followed as standard of care at each institution.    

*25(9,$%$+1(QGRSURVWKHVLV 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 


CONFIDENTIAL INFORMATION                         
0'3URWRFRO7HPSODWH
5HYLVLRQ
'RF7\SH*&

RI
 5HIHUHQFHV
 /RZHOO5HWDO3RSOLWHDO$UWHU\$QHXU\VPV7KH5LVNRI1RQRSHUDWLYH0DQDJHPHQW$QQDOV
RI9DVFXODU6XUJHU\S
 %ODQFR(HWDO2SHUDWLYH5HSDLURI3RSOLWHDO$QHXU\VPV(IIHFWRI)DFWRUV5HODWHGWRWKH
%\SDVV3URFHGXUHRQ2XWFRPH$QQDOVRI9DVFXODU6XUJHU\S
 :DLQ5$DQG*+LQHV$&RQWHPSRUDU\5HYLHZRI3RSOLWHDO$UWHU\$QHXU\VPV&DUGLRORJ\
LQ5HYLHZS
 0LG\'HWDO$5HWURVSHFULYH0XOWLFHQWHU6WXG\RI(QGRYDVFXODU7UHDWPHQWRI3RSOLWHDO
$UWHU\$QHXU\VP-RXUQDORI9DVFXODU6XUJHU\S
 YDQ%RFNHO+DQG-+DPPLQJ9DVFXODU6XUJHU\LQ/RZHU([WUHPLW\$QHXU\VPV5
5XWKHUIRUG(GLWRU(OVHYLHU6DXQGHUV'HQYHU&RORUDGRS
 &LQD&(QGRYDVFXODU5HSDLURI3RSOLWHDO$QHXU\VPV-RXUQDORI9DVFXODU6XUJHU\
S
 'HQW7HWDO0XOWLSOH$UWHULRVFOHURWLF$UWHULDO$QHXU\VPV$UFKLYHVRI6XUJHU\
S
 /DZUHQFH36/RUHQ]R5LYHURDQG-/\RQ7KH,QFLGHQFHRI,OLDF)HPRUDODQG3RSOLWHDO
$UWHU\$QHXU\VPVLQ+RVSLWDOL]HG3DWLHQWV-RXUQDORI9DVFXODU6XUJHU\S
 6]LODJ\L(56FKZDUW]DQG'5HGG\3RSOLWHDO$UWHULDO$QHXU\VPV$UFKLYHVRI6XUJHU\
S
*DOODQG5%DQG750DJHH0DQDJHPHQWRI3RSOLWHDO$QHXU\VP%ULWLVK-RXUQDORI
6XUJHU\S
7LHOOLX,)-HWDO7UHDWPHQWRI3RSOLWHDO$UWHU\$QHXU\VPV:LWKWKH+HPREDKQ6WHQW*UDIW
-RXUQDORI(QGRYDVFXODU7KHUDS\S
$XOLYROD%HWDO3RSOLWHDO$UWHU\$QHXU\VPV$FRPSDULVRQRI2XWFRPHVLQ(OHFWLYH9HUVXV
(PHUJHQW5HSDLU-RXUQDORI9DVFXODU6XUJHU\S
:KLWHKRXVH:HWDO/LPE7KUHDWHQLQJ3RWHQWLDORI$UWHULRVFOHURWLF3RSOLWHDO$UWHU\
$QHXU\VPV6XUJHU\S
6DUFLQD$HWDO6XUJLFDO7UHDWPHQWRI3RSOLWHDO$UWHU\$QHXU\VP-RXUQDORI&DUGLRYDVFXODU
6XUJHU\S
'DZVRQ,5%6LHDQG-+YDQ%RFNHO$WKHURVFOHURWLF3RSOLWHDO$QHXU\VP%ULWLVK-RXUQDO
RI6XUJHU\S
+XDQJ<HWDO(DUO\&RPSOLFDWLRQVDQG/RQJ7HUP2XWFRPH$IWHU2SHQ6XUJLFDO
7UHDWPHQWRI3RSOLWHDO$UWHU\$QHXU\VPV,V([FOXVLRQZLWK6DSKHQRXV9HLQ%\SDVV6WLOOWKH
*ROG6WDQGDUG"-RXUQDORI9DVFXODU6XUJHU\S
7LHOOLX,HWDO(QGRYDVFXODU7UHDWPHQWRISRSOLWHDO$UWHU\$QHXU\VPV5HVXOWVRID
3URVSHFWLYH&RKRUW6WXG\-RXUQDORI9DVFXODU6XUJHU\S
0RKDQ,9HWDO(QGRYDVFXODU3RSOLWHDO$QHXU\VP5HSDLU$UHWKH5HVXOWV&RPSDUDEOHWR
2SHQ6XUJHU\(XURSHDQ-RXUQDORI9DVFXODUDQG(QGRYDVFXODU6XUJHU\S
'DZVRQ,HWDO$V\PSWRPDWLF3RSOLWHDO$QHXU\VP(OHFWLYH2SHUDWLRQ9HUVXV&RQVHUYDWLYH
)ROORZXS%ULWLVK-RXUQDORI6XUJHU\S
'DZVRQ,HWDO3RSOLWHDO$UWHU\$QHUX\VPV/RQJWHUP)ROORZXSRI$QHXU\VPDO'LVHDVH
DQG5HVXOWVRI6XUJLFDO7UHDWPHQW-RXUQDORI9DVFXODU6XUJHU\S
%DUU\0&HWDO(QGROXPLQDO*UDIW6WHQWLQJRI3HULSHUDO$QHXU\VPV4XHVWLRQDEOH5HVXOWV
&RPSDUHG:LWK&RQYHQWLRQDO6XUJHU\7KH5R\DO&ROOHJHRI6XUJHRQV(GLQEXUJK
S
&XUL0$HWDO0LGWHUPRXWFRPHVRIHQGRYDVFXODUSRSOLWHDODUWHU\DQHXU\VPUHSDLU
-RXUQDORI9DVFXODU6XUJHU\S

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1 
Doc Type: GC 
 
29 of 30 
23. Pittathankal, A.A., et al., Expansion Rates of Asymptomatic Popliteal Artery Aneurysms. 
European Journal of Vascular and Endovascular Surgery, 2004. 27: p. 382-4. 
24. Geraghty, P.J., Endovascular Treatment of Lower Extremity Aneurysms. Seminars in  
Vascular Surgery, 2008. 21: p. 195-9. 
25. Mahmood, A., et al., Surgery of Popliteal Artery Aneurysms: A 12-year Experience. Journal of 
Vascular Surgery, 2003. 37(3): p. 586-93. 
26. Nelson, P.R. and W. Anthony Lee, Endovascular Treatment Of Popliteal Artery Aneurysms. 
Vascular, 2006. 14(5): p. 297-304. 
27. Jones, T., et al., Graft Patency Is Not the Only Clinical Predictor of Success After Exclusion 
and Bypass of Popliteal Artery Aneurysms. Journal of Vascular Surgery, 2003. 37(2): p. 392-
8. 
28. Mehta, M., et al., Outcome of Popliteal Artery Aneurysms After Exclusion and Bypass: 
Significance of Residual Patent Branches Mimicking Type II Endoleaks. Journal of Vascular 
Surgery, 2004. 40(5): p. 886-90. 
29. Laxdal, E., et al., Surgical Treatment of Popliteal Artery Aneurysms. Scandinavian Journal of 
Surgery, 2004. 93: p. 57-60. 
30. Pulli, R., et al., Surgical Management of Popliteal Artery Aneurysms: Which Factors Affect 
Outcomes? Journal of Vascular Surgery, 2006. 43: p. 481-7. 
31. Borowicz, M.R.R., J.G., et al., Occlusive Disease Associated with Popliteal Aneurysms: 
Impact on Long Term Graft Patancy. Journal of Cardiovascular Surgery, 1998. 39(2): p. 137-
40. 
32. Huang, Y. and P. Gloviczki, Popliteal Artery Aneurysms: Rationale, Technique, and Results of 
Endovascular Treatment. Perspectives in Vascular Surgery and Endovascular Therapy, 2008. 
20(2): p. 201-213. 
33. Antonello, M., et al., Endovascular Treatment of Asympotmatic Popliteal Aneurysms: 8-year 
Concurrent Comparison with Open Repair. Journal of Cardiovascular Surgery, 2007. 48(3): p. 
267-74. 
34. Henry, M., et al., Percutaneous Endovascular Treatment of Peripheral Aneurysms. Journal of 
Cardiovascular Surgery, 2000. 41(6): p. 871-83. 
35. Tielliu, I.F.J., et al., Stent fractures in the Hemobahn/Viabahn stent graft after endovascular 
popliteal aneurysm repair. Journal of Vascular Surgery, 2010. 51(6): p. 1413-1418. 
36. Howell, M., et al., Wallgraft Endoprosthesis for the Percutaneous Treatment of Femoral and 
Popliteal Artery Aneurysms. Journal of Endovascular Surgery, 2002. 9(1): p. 76-81. 
37. Rajasinghe, H.A., et al., Endovascular Exclusion of Popliteal Artery Aneurysms With 
Expanded Polytetrafluoroethylene Stent-Grafts: Early Results. Vascular and Endovascular 
Surgery, 2007. 40(6): p. 460-466. 
38. Antonello, M., et al., Open repair versus endovascular treatment for asymptomatic popliteal 
artery aneurysm: Results of a prospective randomized study. Journal of Vascular Surgery, 
2005. 42(2): p. 185-193. 
39. Kim, B., et al., Comparison of Endovascular and Open Popliteal Artery Aneurysm Repair. 
Journal of Vascular Surgery, 2010. 6(Supplement 1): p. 60S-61S. 
40. 40. Marin, M., et al., Transfemoral Endoluminal Stented Graft Repair of a Popliteal Artery 
Aneurysm. Journal of Vascular Surgery, 1994. 19(4): p. 754-7. 
41. Lagana, D., et al., Endovascular Treatment of Femoropopliteal Aneurysms: A Five-Year 
Experience. Cardiovascular and Interventional Radiology, 2006. 29(5): p. 819-25. 
42. van Sambeek, M., et al., Endovascular Stent-Grafts for Aneurysms of the Femoral and 
Popliteal Arteries. Annals of Vascular Surgery, 1999. 13(3): p. 247-253. 

GORE® VIABAHN® Endoprosthesis 
MD134619 FPR 14-03 PROT Revision#: 2 Doc Type: SP 
 
 
CONFIDENTIAL INFORMATION                         
MD133246 Protocol Template 
Revision#: 1 
Doc Type: GC 
 
30 of 30 
43. Marcade, J.P., Stent Graft for Popliteal Aneurysms.  Six Cases with Cragg Endo-Pro System 
1 MintecTM. Journal of Cardiovascular Surgery, 1996. 37(Supplement 1 to No.3): p. 41-4. 
44. Shames, M., et al., Treatment of Embolizing Arterial Lesions with Endoluminally Placed Stent 
Grafts. Annals of Vascular Surgery, 2002. 16(5): p. 608-12. 
Ghotbi, R., et al., Stent-Graft Placement in Popliteal Artery Aneurysms: Midterm Results. 
Vascular Disease Management, 2007. 4(4): p. 123-127. 
45. Jung, E., et al., Long-Term Outcome of Endovascular Popliteal Artery Aneurysm Repair. 
Annals of Vascular Surgery, 2010. 24(7): p. 871-875. 
46. Thomazinho, F., et al., Endovascular Treatment of Popliteal Artery Aneurysm. Journal 
Vascular Brasileiro, 2008. 7(1): p. 38-43. 
47. Tielliu, I., et al., Endovascular Treatment of Popliteal Artery Aneurysms: Is the Technique a 
Valid Alternative to Open Surgery? Journal of Cardiovascular Surgery, 2007. 48(3): p. 275-9. 
48. Begovac, P.C., et al., Improvements in GORE-TEX(R) Vascular Graft Performance by 
Carmeda (R) BioActive Surface Heparin Immobilization. European Journal of Vascular and 
Endovascular Surgery, 2003. 25(5): p. 432-7. 
49. Maru, S., et al., Mid-Term Results of Endovascular Repair of Popliteal Artery Aneurysms with 
Covered Stents: The Significance of Run-Off Score On Primary Patency, in 2008 Society for 
Vascular Surgery Annual Meeting. 2008: San Diego, CA. 
50. Idelchik, G., et al., Endovascular Exclusion of Popliteal Artery Aneurysms with Stent-Grafts: A 
Prospective Single-Center Experience. Journal of Endovascular Therapy, 2009. 16: p. 215-
223. 
51. Ascher, E., et al., Duplex-Guided Endovascular Repair of Popliteal Artery Aneurysms (PAAs): 
A New Approach to Avert the Use of Contrast Material and Radiation Exposure. European 
Journal of Vascular and Endovascular Surgery, 2010. 39: p. 769-773. 
52. Etezadi, V., et al., Endovascular Treatment of Popliteal Artery Aneurysms: A Single-center 
Experience. Journal of Vascular and Interventional Radiology, 2010. 21(6): p. 817-823. 
53. Le, H.C., et al., Endovascular Repair of Popliteal Artery Aneurysms with GORE VIABAHN 
Stent-Graft: Early Results, in Society of Interventional Radiology (SIR) 35th Annual Scientific 
Meeting. 2010, Journal of Vascular and Interventional Radiology: Tampa, FL. p. S81-S82. 
54. Rutherford, R., et al., Recommended Standards for Reports Dealing with Lower Extremity 
Ischemia: Revised Version. Journal of Vascular Surgery, 1997. 26: p. 517-38. 
55. ISO 14155. 2011. Clinical investigation of medical devices for human subjects 
56. White, G., et al., Type III and Type IV Endoleak: Toward a Complete Definition of Blood Flow 
in the Sac After Endoluminal AAA Repair. Journal of Endovascular Surgery, 1998. 5: p. 305-
9. 
57.  Huang, Y., et al., Early complications and long-term outcome after open surgical treatment of 
popliteal artery aneurysms: is exclusion with saphenous vein bypass still the gold standard? J 
Vasc Surg, 2007. 45(4): p. 706-713; discussion 713-5 
58.  Ravn, H., A. Wanhainen, and M. Bjorck, Surgical technique and long-term results after 
popliteal artery aneurysm repair: Results from 717 legs. J Vasc Surg, 2007. 46(2): p. 236-43. 
59. Code of Federal Regulations Title 21 Section 56.109, D.o.H.a.H. Services, Editor. 2011. 
60. Code of Federal Regulations Title 21 Section 812.3, D.o.H.a.H. Services, Editor. 2011. 
61.  Pulli R, Dorigo W, Castelli P, et al. A multicentric experience with open surgical repair and 
endovascular exclusion of popliteal artery aneurysms. European Journal of Vascular & 
Endovascular Surgery 2013;45(4):357-363. 
62. Garg K, Rockman CB, Kim BJ, et al. Outcome of endovascular repair of popliteal artery 
aneurysm using the Viabahn endoprosthesis. Journal of Vascular Surgery 2012;55(6):1647-
1653.