GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
Conditions: Peripheral Arterial Disease
Sponsor: W.L.Gore & Associates

7 June 2016 (Revision #2) 
 
 
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Nothing herein is to be disclosed in any way without the prior express permission of 
W. L. Gore & Associates, Inc. 
 
 
 
 
 
 
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study 
-Treatment of patients with symptomatic peripheral arterial disease in superficial 
femoral arteries- 
 
 
 
Protocol Number: JPS 16-03 
 
 
Protocol Date: June 7, 2016 
 
 
NCT Number: NCT04706273 
 
 
 
 
W. L. Gore & Associates, Inc. 
Medical Products Division

7 June 2016 (Revision #2) 
 
 
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Execution Plan for Post-Marketing Surveillance Study 
 
 
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study  
-Treatment of patients with symptomatic peripheral arterial disease in superficial femoral 
arteries- 
 
1. Study Device 
Category 
Instrument and Apparatus(07)Visceral 
Function Substitute Device 
Generic Name 
Stent graft with heparin for blood vessel 
Commercial Name 
GORE® VIABAHN® Endoprosthesis 
 
2. Purpose of surveillance study 
To confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® 
Endoprosthesis (hereafter “VB device”) for the treatment of symptomatic peripheral arterial disease in the 
superficial femoral arteries.  
 
3. Planned number of subjects and its rationale 
Planned number of subjects: A minimum of 250 cases (Enrollment will be continued until 250 patients 
with lesion length greater than or equal to 15 cm will be enrolled) 
 
Rationale: 
The number of subjects are planned so that the stent fracture and also the effect for the device efficacy 
and safety due to the stent fracture can be evaluated.   
 
4. Patients to be subjected to this surveillance study  
Patients with symptomatic peripheral arterial disease in superficial femoral artery lesions 10cm or more in 
length with reference vessel diameters ranging from 4.0 to 7.5mm (hereafter, “study target patient”) and 
also other patients had treatments with VB device during the enrollment period in addition to the study 
target patient. The patients who have the treatment of traumatic or iatrogenic vessel injury in thoracic, 
abdominal, and pelvic arteries (except the aorta, coronary, brachiocephalic, carotid, vertebral and 
pulmonary arteries) with VB device are not included into this study. 
 
5. Planned number of institutions by department  
The planned number of institutions: About 60 institutions which conclude a contract that adheres to GPSP 
ordinances after the study initiation, or use the GORE® VIABAHN® Endoprosthesis before conclusion 
of a contract that adheres to GPSP ordinances and NHG knows that information. This institutions includes 
the study sites for VJH-11-01 study. 
 
The number of institutions of VHJ-11-01 Pre-Market Study: 15 sites 3 departments (Vascular surgery 
department: 6 sites, Cardiovascular internal medicine department: 6 sites, Radiology department: 3 sites) 
 
6. Method of Surveillance Study 
1) To make a written agreement between the participating institutions, NHG, and NHG’s outsourcing 
contractor on the surveillance study. 
2) This survey will continuously enroll all patients treated for symptomatic peripheral arterial disease 
with this device in each of the participating institutions, except the patients who have the treatment of 
traumatic or iatrogenic vessel injury in thoracic, abdominal, and pelvic arteries (except the aorta, 
coronary, brachiocephalic, carotid, vertebral and pulmonary arteries) with VB device. The patients 
who have a treatment with VB device before conclusion of a contract will be enrolled to this study 
retrospectively.  
3) The surveillance of the PAD patients who have a treatment with VB device is conducted in accordance 
with this protocol.  
4) The surveillance of the patients who had a treatment with VB device for the disease except PAD is also 

7 June 2016 (Revision #2) 
 
 
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conducted in accordance with the contents stipulated in Attachment 1 of this protocol.  
5) After one month from the procedure and on annually afterwards, the study doctor needs to submit the 
case report form with inputting the data to Electric Data Capture system that NHG indicates. 
6) After one month from the procedure and on annually afterwards, representatives of NHG or the 
outsourcing contractor are to collect case report forms for the post-marketing surveillance study on 
which necessary items are filled out.  
7) If any deficiencies of VIABAHN are recognized, the physicians responsible for the case or 
representatives of the outsourcing contractor will immediately report them to representatives of NHG 
and the GVP section of NHG will handle them appropriately. 
8) From the approval date, an annual report will be made, reviewed, and approved by the Post-Marketing 
Surveillance Study team and the GVP section of NHG, and then submitted to PMDA. 
 
7. Planned surveillance period 
Total surveillance period: Six years and ten months  
Sales preparation period: About five month 
Enrollment period: About five months (until the 250 cases treated with 15cm of lesion lengths will be 
enrolled) 
Follow-up period: For five years from procedure 
CRF collection period, Analysis period and Data Fixation period: twelve months 
 
8. Items to be investigated 
8.1 Items to be investigated  
The following items are investigated in each time window  
8.1.1 On the procedure day 
• Patient background, pre-operative patient information, etc 
• Device usage information  
• Presence / absence of concurrent treatments and their detail if there was any 
• Rutherford classification 
• ABI 
• Information on antiplatelet drug administration  
• Adverse events and/or device deficiencies and their details (Thrombosis, TLR (Revascularization for 
restenosis or occlusion of the treatment lesion) , Stent graft occlusion, Stent graft stricture etc) 
 
8.1.2 At 1 month Follow-up visits 
• Date of discharge 
• Rutherford classification 
• ABI (or TBI) (Presence / absence of patent of the treatment site) 
• Information on antiplatelet drug administration 
• Adverse events and/or deficiencies and details (Thrombosis, TLR, Stent graft occlusion, Stent graft 
stricture etc) 
 
8.1.3 At 12, 24months Follow-up visits 
• Rutherford classification 
• ABI (or TBI) (Presence / absence of patent of the treatment site) 
• CDUS (Presence / absence of patent of the treatment site) 
• Plain X-ray (Presence / absence of Stent fracture) 
• Information on antiplatelet drug administration  
• Adverse events and/or deficiencies and details (Thrombosis, TLR, Stent graft occlusion and Stent 
graft stricture etc) 
 
8.1.4 At 36, 48 and 60months Follow-up visit 
• Rutherford classification 
• ABI (or TBI) (Presence / absence of patent of the treatment site) 

7 June 2016 (Revision #2) 
 
 
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• CDUS (Presence / absence of patent of the treatment site) 
• Plain X-ray (Presence / absence of Stent fracture) 
• Adverse events and/or deficiencies and details (Thrombosis, TLR, Stent graft occlusion and Stent 
graft stricture etc) 
 
Table 1: Examination schedule 
Diagnostic Test 
Procedure 
1 month 
12 months 
24 months 
36 months 
48 months 
60 months 
Patient background 
and pre-operative 
patient information 
X 
 
 
 
 
 
 
Date of discharge 
 
X 
 
 
 
 
 
Device usage 
information 
X 
 
 
 
 
 
 
Presence / absence of 
concurrent treatments 
and their detail if there 
was any 
X 
 
 
 
 
 
 
Information on 
antiplatelet, 
anticoagulant drug 
administration 
X 
X 
X 
X 
 
 
 
Rutherford 
classification 
X 
X 
X 
X 
X 
X 
X 
ABI (or TBI) 
X 
X 
X 
X 
X 
X 
X 
CDUS 
 
 
X 
X 
X 
X 
X 
Plain X-ray 
 
 
X 
X 
X 
X 
X 
Adverse events and/or 
deficiencies and details 
X 
X 
X 
X 
X 
X 
X 
 
8.2 Focused survey items and concrete survey methods of the items  
Focused survey item: Stent Fracture 
Rationale: The risk of stent placement in the superficial femoral arteries include stent fracture. Since 
VIABAHN has stent wire, it was judged the assessment of long-term safety is important. 
Concrete survey methods of the items: The stent fracture will be confirmed by X-ray at 12, 24, 36, 48 and 
60 months after procedure. 
 
9.  Items and methods of analysis 
Following endpoints for efficacy and safety and focused survey items will be aggregated 
 
9.1 Efficacy: 
9.1.1 Primary assisted patency at 12 and 24 months 
Primary assisted patency defined as hemodynamic evidence of flow through a device that had not 
required a TLR to restore flow after total occlusion. This will be calculated using Kaplan-Meier 
analysis and will be estimated at 12 and 24month.  
9.1.2 Freedom from TLR at 1, 12 and 24months 
Freedom from TLR will be calculated using Kaplan-Meier analysis and will be estimated at 1, 12 and 
24months.  
 
9.2 Safety: 
9.2.1 Occurrence of device- or procedure-related serious adverse events and deficiencies 
Among the valid subjects at procedure, 1, 12, 24, 36, 48 and 60months, the proportion of the subjects 
for whom the occurrence of serious adverse events were reported. 
 

7 June 2016 (Revision #2) 
 
 
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Serious Adverse events / SAE, regardless of their causal relationship with the device are the events 
fall under the below categories among the adverse events/ device deficiencies caused by the device. A 
SAE is classified by the physician who is responsible for the case.   
1) Death 
2) A case in which the event is suspected to cause a life-threatening condition.  
3) A case that requires hospitalization in a hospital or a clinic or an extension of a hospital stay.  
4) Disability  
5) A case in which the event could have resulted in disability.   
6) A case that is serious according to the cases in the above 1) to 5). 
7) A congenital disease or abnormality from which a later generation of a patient will suffer. 
 
Hospitalization without the onset of a new adverse event or aggravation of a pre-procedure 
complication, such as the reasons for hospitalization listed below, will not be handled as a serious 
adverse event. 
• Hospitalization due to treatment that had previously been scheduled before the procedure by 
VIABAHN(hospitalization due to surgery for a pre-procedure complication that can be 
conducted after improvement of the target lesion) 
• Administrative hospitalization (e.g. hospitalization for a regular medical checkup, examination, 
or training) 
• Hospitalization at a rehabilitation facility 
 
9.2.2 Stent fracture 
Stent fracture rate will be calculated using Kaplan-Meier analysis and will be estimated at 12, 24, 36, 
48 and 60months. When an occurrence of fracture was suspected at sites, the image should be sent to 
Core lab for the assessment. 
 
9.3 Assessment period 
Assessment windows are as below; 
 
Table 2: Assessment period 
Follow-up visit 
Ideal allowance of follow-up window 
Analysis window 
Procedure 
0 
0 
1 month 
23~44 
15~59 
12 months 
275~455 
243~546 
24 months 
640~820 
547~911 
36 months 
1005~1185 
912~1275 
48 months 
1370~1550 
1276~1640 
60 months 
1735~1855 
1641~2006 
 
10. Organization for Operation of Post-Marketing Surveillance Study 
The same as that written in Master Plan of Post-Marketing Surveillance Study  
 
11. Name, address, and scope of service of outsourcing contractor when outsourcing a part of the 
surveillance study 
 
Name of outsourcing contractor: SRD  
Address of outsourcing contractor: Hacchohbori3-4-8, Chuoh-ku, Tokyo, Japan 
Range of Services delegated to the contractor: Support of EDC, procedure of IRB, procedure of contract 
and Data Management 
 
12. Others  
There is no other information to describe.