Long Segment Lesion Peripheral Artery Revascularization Feasibility Study
Phase: NA
Conditions: Peripheral Arterial Disease
Sponsor: Endologix



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STP 185-B6 Version Date:  02 May 2017                                                                                                   Page 2 of 85 
 
 
TABLE OF CONTENTS 
2.0 INTRODUCTION 
15 
2.1 
Peripheral Artery Disease Background 
15 
2.2 
Current Treatment Options 
15 
2.3 
Previous Clinical Experience 
20 
3.0 DEVICE / TECHNOLOGY DESCRIPTION 
37 
3.1     Introduction 
37 
3.2     Device Characteristics 
37 
3.3 
Stent Graft 
37 
3.4 
Delivery Catheter 
40 
3.5 
Mechanism of Action 
41 
3.6 
Device Materials 
41 
3.7 
Principles of Operation 
42 
3.8  
User Interface 
42 
4.0 PROPOSED INTENDED USE 
43 
5.0 STUDY DESIGN 
44 
5.1 
Study Design 
44 
5.2 
Study Endpoints 
44 
5.3 
Study Duration 
45 
5.4 
Number of Subjects and Sites 
45 
5.5 
Inclusion Criteria 
45 
5.6 
Exclusion Criteria 
46 
6.0 SUBJECT ENROLLMENT INFORMATION 
48 
6.1 
Written Informed Consent 
48 
6.2 
Enrollment 
48 
6.3 
Duration of Subject Participation 
48 
6.4 
Withdrawal of Subjects 
48 
6.5 
Lost to Follow-Up 
48 
6.6 
Subject Confidentiality 
48 
7.0 RISK-BENEFIT ASSESSMENT 
50 
7.1 
Risks 
50 
7.2 
Risks Minimization 
50 
7.3 
Benefits 
51 
8.0 STUDY PROCEDURE 
53 
8.1 
Vascular Access and Guidewire Delivery 
53 
8.2 
Stent Graft Placement 
53 
8.3 
Follow-Up 
53 
9.0 MATERIALS AND METHODS 
54 
9.1 
Initial Eligibility 
54 
9.2 
Baseline Evaluation 
54 
9.3 
Procedural Evaluation 
54 
9.4 
Discharge Evaluation 
54 
9.5 
Follow-Up Evaluation 
54 
10.0 INVESTIGATIONAL DEVICE DISTRIBUTION AND ACCOUNTABILITY 
55 
10.1 
Device Accountability 
55 
10.2 
Return of Devices 
55 
11.0 ENDPOINTS AND STATISTICAL ANALYSIS PLAN 
56 
11.1 
Endpoints Analyses and Reporting of Results 
56 
11.2 
Primary Safety Endpoint Reporting 
60 
11.3 
Primary Performance Endpoint Reporting: 
60 

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STP 185-B6 Version Date:  02 May 2017                                                                                                   Page 3 of 85 
 
11.4 
Secondary Endpoint Analysis: 
60 
11.5 
Demographic, procedural and safety data: 
60 
11.6 
Imputation for Missing Data 
60 
12.0 ADVERSE EVENTS 
61 
12.1     Adverse Event (AE) 
61 
12.2 
Serious Adverse Event (SAE) 
62 
12.3 
Unanticipated Adverse Device Effect (UADE) 
62 
12.4 
Reporting of Adverse Events 
62 
12.5 
Reporting of Device Failures and Malfunctions 
63 
12.6 
Documentation, evaluation and notification of Serious Adverse Events 
63 
13.0 MONITORING 
64 
13.1  
Selection and Qualification of Monitors (ISO 14155) 
64 
13.2 
Assessment of the Investigation Site (ISO 14155) 
64 
13.3 
Site Initiation (ISO 14155) 
64 
13.4 
Interim Monitoring Visit (ISO 14155) 
64 
13.5 
Close-Out Visit (ISO 14155) 
65 
13.6 
Monitoring Reports (ISO 14155) 
66 
14.0 STUDY ADMINISTRATION 
67 
14.1 
Source Documentation 
67 
14.2 
Clinical Data Management 
67 
14.3 
Criteria for Terminating Study 
68 
14.3 
Criteria for Suspending/Terminating a Study Center 
68 
14.4 
Data Safety Monitoring Board (DSMB) 
69 
15.0 PROTOCOL DEVIATIONS 
70 
16.0 REGULATORY CONSIDERATIONS 
71 
16.1      Maintaining Records 
71 
16.2      Data Storage and Confidentiality 
71 
16.3      Site Record Retention Policy 
71 
16.4      Ethics Committee (EC) and Competent Authority (CA) Approval 
71 
17.0 INVESTIGATOR RESPONSIBILITIES, RECORDS AND REPORTS 
73 
17.1  
Investigator Responsibilities 
73 
17.2 
Investigator Records 
73 
17.3 
Investigator Report 
73 
18.0  PUBLICATIONS 
74 
19.0 DEFINITIONS 
75 
20.0 REFERENCES 
79 
APPENDIX I: SAMPLE INFORMED CONSENT (ENGLISH VERSION) 
82 
APPENDIX II: INSTRUCTIONS FOR USE 
83 
APPENDIX III: SERIOUS ADVERSE EVENT REPORTING PROCEDURES 
84 
 
 
 

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STP 185-B6 Version Date:  02 May 2017                                                                                                   Page 4 of 85 
 
 
LIST OF FIGURES 
Figure 1: Trends in endovascular interventions, major amputation ............................................. 16 
Figure 2: Primary Patency of SFA PTA and/or Stenting (letters indicate TASC ................................ 17 
Figure 3: Primary Patency of SFA Stent Grafting ............................................................................... 18 
Figure 4: Gore Viabahn Evolution ...................................................................................................... 19 
Figure 5: PQ Bypass Stent Graft Encapsulated in ePTFE ............................................................ 38 
Figure 6: NiTi Wire Frame (pictured on a process mandrel) ........................................................ 38 
Figure 7: PQ Bypass Stent Graft Delivery System ......................................................................... 40 
Figure 8: Reported Patency Rates Across TASC II Class A-D .............................................................. 57 
Figure 9: SFA and Popliteal Endovascular Therapies ................................................................... 57 
 
 
 

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STP 185-B6 Version Date:  02 May 2017                                                                                                   Page 6 of 85 
 
 
Protocol Summary 
 
 
PROTOCOL SUMMARY 
Title 
Long Segment Lesion Peripheral Artery Revascularization Study 
Protocol Number 
185 
Device 
PQ Bypass™ Stent Graft System 
Intended Use 
The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter 
in the treatment of patients with symptomatic de novo or restenotic native 
lesions or occlusions of the superficial femoral artery (SFA) and/or proximal 
popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion 
lengths up to 180 mm. 
Regulatory Status 
Investigational Device.  
Number of Centers 
A maximum of 15 international sites (non  U.S.). 
Subject Population 
Up to 65 subjects may be enrolled.  A total of 60 evaluable subjects with a 
documented, atherosclerotic lesion of the native superficial femoral artery 
(SFA) or the superficial femoral and proximal popliteal arteries, suitable for 
treatment with PQ Bypass™ Stent Graft System.  
Study Design 
Prospective, single-arm, multi-center, international, non-randomized, pre-
market, safety and effectiveness clinical investigation.  
Study Objectives 
The primary objective of the feasibility study is to evaluate the safety and 
effectiveness of the PQ Bypass Stent Graft System in the treatment of 
atherosclerotic lesions of the native superficial femoral artery (SFA) or the 
superficial femoral and proximal popliteal arteries.   
 

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STP 185-B6 Version Date:  02 May 2017                                                                                                   Page 7 of 85 
 
Primary Safety Endpoint 
 
The primary safety endpoint for this study is freedom from a major adverse 
event (MAE) at 30 days post-procedure.  An MAE is defined as TLR, 
amputation of the treated limb or death.  
Primary Effectiveness Endpoint 
The primary effectiveness endpoint is defined as stent patency as evidenced 
by a peak systolic velocity ratio (PSVR) < 2.5 from DUS obtained within the 12-
month visit window with no clinically-driven re-intervention within the 
stented segment.  
Secondary Safety 
Endpoints 
Secondary safety endpoints will be evaluated and include:  
1. The combined rate of death at 30 days, target lesion 
revascularization (TLR), index limb amputation, and an increase in 
Rutherford-Becker Classification by 2 classes (comparing pre- to 
post-procedural assessments) at 12 months.  
2. Major adverse vascular event (MAVE) at 30 days, 6 months and 12 
months defined as stent thrombosis, target limb amputation, 
clinically apparent distal embolization, defined as causing end-organ 
damage (e.g. lower extremity ulceration, tissue necrosis, or 
gangrene), procedure related arterial rupture, acute limb ischemia 
or bleeding event requiring transfusion.  
3. The combined rate of serious procedural adverse events, including 
death, myocardial infarction, index limb amputation, and access site 
and treatment site complications requiring surgery, blood 
transfusion (>2 units of PRBC), or prolonged hospital stay within 30 
days of the index procedure. 
Secondary Effectiveness 
Endpoints 
Secondary effectiveness endpoints include: 
1. Acute technical (lesion) success, procedural success and device 
success   
2. Ankle-Brachial Index (ABI) and Toe-Brachial Index (TBI) at 1, 6 and 12 
months   
3. Target vessel revascularization (TVR) at 6 and 12 months   
4.  Limb ischemia by Rutherford-Becker Classification at Baseline, 1, 6, 
and 12 months.  
5. Number of any type of index limb amputations at 6 and 12 months   
6. Absolute Claudication Distance as measured by the Exercise 
Tolerance Test (TASCII) assessed in subjects at baseline, 1, 6, and 12 
months.  
7. Target lesion revascularization (TLR) at 1, 6 and 12 months. 
8. The rate of primary assisted patency through follow-up defined as: 
revascularization of non-occlusive (<99%) stenosis within the stent 
graft or immediately above or below the treated arterial segment 
with less than 50% residual stenosis. 
9. The rate of secondary patency through follow-up defined as: 
revascularization of occlusion (100%) within the stent graft or 
immediately above or below the treated arterial segment with less 
than 50% residual stenosis. 
Additional Endpoints 
The following additional endpoints will also be reported: 
1. A combined rate of death at 30 days, or TLR, index limb amputation, 
and an increase in Rutherford-Becker Classification by 2 classes 
(comparing pre- to post-procedural assessments) measured at 24 
months.  

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STP 185-B6 Version Date:  02 May 2017                                                                                                   Page 8 of 85 
 
2. Target vessel revascularization (TVR) at 24-month post-procedure.  
3. Limb ischemia improvement by Rutherford-Becker (improvement in 
scale by ≥ 1) at 24 months.  
4. Major Adverse Vascular Event (MAVE) by 24 months, defined as: 
Stent thrombosis, target limb amputation, or clinically apparent 
distal embolization, defined as causing end-organ damage (e.g. 
lower extremity ulceration, tissue necrosis, or gangrene).   
5. Procedure related arterial rupture, acute limb ischemia, or bleeding 
event requiring transfusion. Number of any type of index limb 
amputations at 24-month follow-up.  Target lesion revascularization 
(TLR) at 24 months post-procedure. 
Inclusion Criteria 
The subject must meet all of the following criteria at the time of eligibility: 
1. Age ≥ 18 years and of age of legal consent.  
2. Women of child bearing potential must have a negative pregnancy 
test within 7 days prior to the index procedure.  
3. Subject has lifestyle limiting claudication or rest pain (Rutherford 
Becker scale 2-4)* with a resting ABI < 0.9.  Resting TBI is utilized only 
if unable to reliably assess ABI. TBI must be <0.7.  These assessments 
are required for the target limb, but both limbs are preferred.  
4. A superficial femoral artery lesion with >50% stenosis or occlusion 
which requires treatment.   
5. Stenotic lesion(s) or occluded length within the same vessel (one long 
or multiple serial lesions) ≥ 80mm to ≤180mm.  
6. Reference vessel diameter (RVD) ≥ 5.0mm and ≤ 6.7 mm, 
angiographically/CTA/MRA defined. 
7. Patent popliteal artery 3 cm proximal to tibial plateau  
8. At least 1 patent tibial artery to the foot (<50% stenosis) 
9. The target lesion(s) can be successfully crossed with a guide wire and 
dilated.  
10. Adequate aortoiliac or common femoral “inflow” is defined as <30% 
stenosis after either PTA or stenting of the inflow lesion.  After 
treatment of the inflow lesion, the residual pressure gradient across 
the target lesion will be obtained and if the peak to peak pressure 
gradient is < 20mmHg, the subject will be included in the study.  
Subjects enrolled with aortoiliac or common femoral artery lesions 
resulting in poor inflow, must be treated prior to receiving the study 
treatment. (Same Day or earlier) 
11. If a subject has bilateral obstructive SFA disease, only 1 leg may be 
treated with the investigational device in the study.  
a. 
If the study leg is treated first, the contra-lateral procedure 
should not be performed until at least 30 days after the 
index procedure (staged); and should only be performed 
with an approved (CE Marked) device. 
b. If the contra-lateral leg is treated with an approved (CE 
Marked) device prior to treatment of the study leg, 
treatment of the contra-lateral leg should be performed at 
least 15 days prior to the treatment of the study leg. 
12. The subject is eligible for standard surgical repair, if necessary.  
13.  A subject who requires a coronary intervention should have it 
performed at least 30 days prior or 30 days post the treatment of the 
target lesion.  

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STP 185-B6 Version Date:  02 May 2017                                                                                                   Page 9 of 85 
 
14. Subject must provide written informed consent.  
15. Subject must be willing to comply with the specified follow-up 
evaluation schedule. 
*Note – Patients with stage 2 Rutherford classification can be included when 
conservative physical and drug therapy have been unsuccessful. 
Exclusion Criteria 
The following must NOT be present at the time of subject eligibility:  
1. Age greater than 90 
2. Thrombophlebitis, within the previous 30 days.  
3. Receiving dialysis or immunosuppressant therapy within the previous 
30 days.  
4. Thrombolysis of the target vessel within 72 hours prior to the index 
procedure, where complete resolution of the thrombus was not 
achieved.  
5. Stroke within the previous 90 days.  
6. Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal 
artery. 
7. Required stent placement via a popliteal approach.  
8. Procedures which are pre-determined to require stent-in-stent 
placement to obtain patency, such as in-stent restenosis.  
9. Significant vessel tortuosity or other parameters prohibiting access to 
the lesion or 90° tortuosity which would prevent delivery of the stent 
device.  
10. Required stent placement within 1 cm of a previously deployed stent.   
11. Known allergies to any of the following: aspirin and clopidogrel 
bisulfate (Plavix®), ticlopidine (Ticlid ®), and prasugrel (Effient®); 
heparin; Nitinol (nickel titanium); or contrast agent, that cannot be 
medically managed.  
12. Presence of thrombus prior to crossing the lesion.  
13. Known or suspected active infection at the time of the procedure.  
14. Use of cryoplasty, laser, or atherectomy devices in the target vessel 
at the time of index procedure.  
15. Restenotic lesion that had previously been treated by atherectomy, 
laser or cryoplasty within 3 months of the index procedure.  
16. History of neutropenia, coagulopathy, or thrombocytopenia that was 
unexplained or is considered to be at risk for reoccurrence.  
17. Known bleeding or hypercoagulability disorder or significant anemia 
(Hb<8.0) that cannot be corrected.  
18. Subject has the following laboratory values: a. platelet count less 
than 80,000/μL, b. international normalized ratio (INR) greater than 
1.5, c. serum creatinine level greater than 2.0 mg/dL.  
19. Subject requires general anesthesia for the procedure.  
20. Major distal amputation (above the transmetatarsal) in the study or 
non-study limb. 
21. Patient has had a revascularization procedure on the target limb 
within 30 days of the planned index procedure  
22. Patient has a planned amputation of the target limb 
23. Previous bypass surgery on the target limb 
24. Subject is pregnant or plans to become pregnant during the study.  

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STP 185-B6 Version Date:  02 May 2017                                                                                                   Page 10 of 85 
 
25. Subject has a co-morbid illness that may result in a life expectancy of 
less than 1 year.  
26. Subject is participating in an investigational study of a new drug, 
biologic or device at the time of study screening.  
Estimated Enrollment Period 
Twelve (12) months 
Study Duration for Each Subject 
Two (2) years 
Proposed Study Duration  
Approximately three (3) years or longer 
(1 year for subject recruitment and 2 years follow-up) 
Sponsor 
 
PQ Bypass Medical, Inc.  
269 N. Mathilda Avenue 
Sunnyvale, CA 94086 
USA 
Contact : Ziad Rouag 
Tel : +1 (415) 531-4647 
Email: zrouag@pqbypass.com 
Data Management 
Data Management will be conducted by an independent data management 
organization. 
Core Imaging Laboratory 
An independent duplex ultrasound and angiographic core laboratory will 
review and analyze key study variables.   
Clinical Events Committee  
An independent Clinical Events Committee (CEC) or Independent Medical 
Reviewer will be used to review and adjudicate primary and secondary safety 
endpoints (including major adverse events), serious adverse events and 
device related adverse events. 
DSMB 
An independent Data Safety Monitoring Board (DSMB) will be used to review 
study data on an ongoing basis and identify any potential safety trends.   
Monitoring 
The study will be monitored by independent contract monitors.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STP 185-B6 Version Date:  02 May 2017                                                                                                   Page 12 of 85 
 
1 Use of retrospect ve assessments, pr or to s gn ng of nformed consent, were used f they were performed as rout ne standard of care  
2 Br ef phys ca  exam at base ne s targeted to assess mb schem a and concurrent med ca  cond t ons to assess sub ect e g b ty for study part c pat on   Hea th status assessment s performed at d scharge and subsequent 
c n c v s ts to assess for mb schem a and other changes n med ca  cond t ons that are reportab e as adverse events  
3 CK at d scharge t me po nt s obta ned on y f sub ect shows s gns or symptoms of card ac schem a   CK MB s requ red f CK s e evated (≥ 2X the aboratory upper m t of norma )   f CK and CK MB s e evated, and acute 
myocard a  nfarct on s d agnosed, the sub ect w  be treated accord ng to hosp ta  procedures  
4 30 day ECG s performed f sub ect exper ences any schem c symptoms s nce d scharge  
5 Ang ography pe formed both pre procedure and post procedure to record data needed for percent d ameter stenos s and other measures   Add t ona  ang ography may be performed at nvest gator d scret on or to 
assess events  
6 Dup ex U trasound s to be comp eted at each v s t  
7 At base ne C n ca  Category Sca e, dur ng fo ow up, both C n ca  Catego y and C n ca  mprovement Rutherford Becker Sca es  
8 Pe form Toe Brach a  ndex (TB ) on y f unab e to re ab y assess AB  read ng   Tests are performed n rest ng state   Post procedure fo ow up assessments depend on wh ch test was performed pre procedure  
9 P av x s recommended for one year post procedure; ASA s recommended for a  sub ects ndef n te y  
 

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STP 185-B6 Version Date:  02 May 2017                                                                                                   Page 14 of 85 
 
 
 
Change History 
 
 
 
Revision 
Letter 
Change Description 
A 
Initial Release 
A1 
Amendments per Austrian EC requests  
B 
• 
Lesion length adjustment 
• 
Clinical outcome data update 
• 
Device description update 
• 
Statistical Plan update from 30 to 60 evaluable patients 
• 
Risk benefit update 
• 
Addition of x-ray at 12 month follow-up 
• 
Minor editorial updates  
B1 
Added “Section 18 PUBLICATIONS” as requested by Latvian Authorities 
B2 
 Updated statistical plan rationale per Italian EC request using superiority hypothesis instead    of a 
non-inferiority  
B3 
• 
Updated EU Rep  
• 
Updated X-Ray Language   
• 
Updated Reporting SAE (Changed to 7 Days)  
• 
Corrected typographical error-No Radiopaque Marker on the graft 
• 
Corrected Page numbering (General) 
• 
Clarified IC-10 
B4 
• 
Updated secondary safety endpoints 
• 
Updated Schedule of Assessments 
• 
Updated Section 13.0 Monitoring 
• 
Added Appendix III – Serious Adverse Event Reporting 
B5 
• 
Inclusion criterion #11 modified to reflect that if subject has 2 limbs eligible for the study, 
only one can be treated in the study. 
• 
Exclusion criterion #26 – updated to reflect that subject participating in another study 
should be excluded. 
• 
Section 2.3 – Previous Clinical Experience – Added results from STP 115 to report, 
including table which compares STP 185 to STP 115 as well as baseline demographics, 
lesion characteristics, technical success and safety and patency outcomes for the first 60 
subjects through 6 months and for n=35 at 12 months.  Comparison tables for safety and 
patency also added.  
• 
Section 11 – Statistical Plan – Modified to address BFARM questions with regards to 
hypothesis testing.  
• 
Section 14 - Database Management section updated to address BFARM questions with 
regards to data management process. 
B6 
• 
Section 11 – Statistical Plan – Modified to address BFARM question with regards to 
statistical tests used  

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STP 185-B6 Version Date:  02 May 2017                                                                                                   Page 15 of 85 
 
 
2.0 
INTRODUCTION 
2.1 
Peripheral Artery Disease Background 
Atherosclerosis is a systemic disease process of plaque build up within arterial vessels.1    
This plaque consists of fat deposits, cholesterol, calcium and other substances, and when 
plaque continues to accumulate, the vessel can become hardened, narrowed and/or 
completely occluded.  The subsequent manifestation of narrowed arteries is a reduction of 
oxygen rich blood flow to organs and other parts of the body.2 In peripheral arterial disease 
(PAD), the accumulation of plaque blocks or reduces the flow of oxygen rich blood to the 
arms, legs and pelvis, which can lead to numbness, pain and dangerous infections.2 Removal 
of these narrowings or obstructions is critical to restoring adequate blood flow, maintaining 
healthy vessels, tissues and organs. 
 
The most common risk factors for developing PAD are diabetes mellitus, cigarette smoking, 
advanced age, hyperlipidemia and hypertension.3  In 2003, it was estimated that more 
than 27 million people in North America and Europe were affected by PAD,4 and in 2007, it 
was estimated that PAD affects more than one in five people over the age of 70.5   Despite 
the risk factors, less than 50 percent of patients with PAD know that they have the 
condition.5 Patients suffering from PAD may also have symptomatic or asymptomatic 
coronary and/or carotid arterial disease and are three to six times more likely to experience 
a heart attack or stroke than patients without PAD.5 
 
2.2 
Current Treatment Options 
The gold standard for treating lesions in the infrainguinal segment is surgical bypass using an 
autologous vein. Unfortunately, adequate vein is often unavailable and the long term 
results of surgical bypasses using synthetic material are less satisfactory.6 Over the past 
three decades, advances in endovascular technology, which is less invasive than surgery, 
have led to increasing use of endovascular tools in lieu of surgical options. Today, treatments 
are recommended based on specific lesion characteristics. The Trans Atlantic Inter Society 
Consensus (TASC) group recommends treatment using their Type A D classification system, 
which incorporates lesion length and lesion type (stenosis vs. occlusion, denovo vs. re  
stenosis, etc.). In 2000, the first TASC meeting recommended that TASC A lesions be treated 
endovascularly, TASC D lesions be treated surgically and had no recommendation for TASC 
B and C lesions due to lack of evidence.7 In 2007, updated recommendations were 
published that both modified the classifications and recommended endovascular therapy 
for TASC B lesions and surgery for TASC C lesions in “good risk” patients.8  Many in the 
community felt the TASC II recommendations were not representative of the latest data on 
novel endovascular methods, prompting critiques in favor of an “endovascular first” 
approach  for  all  femoropopliteal  lesion  types.9, 10,11        These critiques  were 
consistent with the market, which increased use of endovascular therapies by 3x while 
reducing surgical and amputation rates from 1996 2006.12 (Figure 1). 
 
 

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STP 185-B6 Version Date:  02 May 2017                                                                                                   Page 16 of 85 
 
Figure 1: Trends in endovascular interventions, major amputation  
and lower extremity bypass surgery 
 
 
 
The increasing trend of the “endovascular first” approach is supported by current research 
on endovascular and surgical outcomes. Which endovascular method to use for which lesion 
type, however, continues to be a research topic of interest. Percutaneous transluminal 
angioplasty (PTA) appears most effective in treating relatively short (<5 cm) femoropopliteal 
lesions with an average 12 month primary patency of 74% (61 84%).13,14, 15, 16, 17, 18, 19   
With lesions longer than 5 cm, however, PTA primary patency drops to 35% (13  56%).20, 21, 
22, 23, 24, 25, 26, 27, 28 Stenting after PTA improves primary patency in lesions longer than 
5 cm (mean 72%, 54 87%), but PTA and stenting for lesions >10 cm long is less effective 
(mean 43%, 22 55%).13,16, 18 ,20,24,29, 30, 31, 32, 33 In terms of TASC categories, PTA 
and/or stenting have outcomes equal to or better than surgery for TASC A and B lesions, but 
fail to match surgery’s patency rates in TASC C or D lesions (Figure 2).34 
 
 

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STP 185-B6 Version Date:  02 May 2017                                                                                                   Page 20 of 85 
 
 
Once CE Marked and FDA approved, the PQ Bypass Stent Graft would constitute a second 
SFA indicated stent graft.  The PQ Bypass stent graft present however several distinct 
design differences over the Gore Viabahn including: 
• A higher radial force designed to reduce kinking and fracture  
• Exposed nitinol proximal end edge designed to reduce risk of edge stenosis 
• Tapered distal end radial force designed to allow the stent graft to tapper 
naturally with the vessel diameter    
• Nitinol stent encapsulated in ePTFE designed to limit nitinol exposure in the 
vessel  
It is believed that these design differences will result in distinct clinical advantages over 
the Gore Viabahn 
2.3 
Previous Clinical Experience 
 
STP - 185 
To date only 12 patients have been enrolled in STP 185 study and results are still pending. 
First Patient for STP 185 was treated in Riga, Latvia on 02 March 2016. Table 2 summarizes 
the Clinical Sites currently (conditionally) approved for the STP 185 study.  
 
 
 
 
 
 
 
 
 

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STP 185-B6 Version Date:  02 May 2017                                                                                                   Page 21 of 85 
 
Table 2: Clinical Sites in STP-185 
Number 
Clinical Site 
Country 
Enrolled 
01 
Stradins University Hospital, Riga, Latvia 
Latvia 
9 
02 
Universidad Católica de Chile, Santiago, Chile 
Chile 
0 
03 
Poznan University of Medical Sciences, Poznań, Poland 
Poland 
0 
04 
Institute of Hematology Medicine, Warsaw, Poland 
Poland 
0 
05 
Gdańsk Medical University, Gdańsk, Poland 
Poland 
0 
06  
University Leipzig Medical Centre, Leipzig, Germany 
Germany 
0 
08 
San Raffaele Scientific Institute Hospital, Ospedale San Raffaele, 
Milano, Italy 
Italy 
0 
09 
Arcispedale Santa Maria Nuova, Reggio Emilia, Italy 
Italy 
0 
10 
Mirano Hospital, Mirano, Italy 
Italy 
0 
12 
Medical University of Graz, Austria 
Austria 
1 
13 
Hanusch Krankenhaus, Vienna, Austria 
Austria 
0 
 
Table 3 summarizes basic demographic information for the first 10 patients (available data). As the 
study has just started outcomes will be reported as these become available in the future.  
Table 3 : Demographics of First 10 Patients 
Demographics 
Subjects (N = 10) 
Age, (years) Mean 
(Range), N 
62.5 
(53 - 72), 10 
Male Gender, (%, m/N) 
90% (9/10) 
SFA Lesion Length, (cm) Mean  
(Range), N 
13.8 
(7.9 - 19.0), 10 
  Chronic Total Occlusion, (%, m/N) 
75% (6/8) 
 TASC II Lesion Type, (%, m/N) 
    B 
    C 
 
30% (3/10) 
70% (7/10) 
Calcification, (%, m/N) 
    Mild 
    Moderate 
 
29%(2/7) 
71%(5/7) 
Number of Run-Off Vessels, (%, m/N) 
   1 
   2 
   3 
 
10% (1/10) 
30% (3/10) 
60% (6/10) 
 
 
 
 

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Table 5: STP 115 Protocol Summary 
 
 
PROTOCOL SUMMARY 
Title: 
PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II) 
Protocol Number 
STP 115 Rev D 
Study Design: 
Prospective, single-arm, multi-center, international, non-randomized, pre-market, safety and 
effectiveness clinical investigation evaluating the PQ Bypass Systems to access, deliver 
guidewires and implant stent grafts for a percutaneous femoropopliteal (fem- pop) 
bypass. 
Study Objective: 
To assess the safety and performance of the PQ Bypass System to access, deliver 
guidewires and implant stent grafts for a percutaneous fem-pop bypass. 
Enrollment: 
Up to 60 subjects will undergo a percutaneous fem-pop bypass, including up to 30 subjects 
in Germany. 
Number of Sites 
Up to 17 international sites (non U.S. sites).   
Study Enrollment 
12-month enrollment period: 
• 
Initial enrollment: Proposed Q4, 2014 
• 
Last enrollment:  Proposed Q3, 2015 
Study Duration 
36 months (12-month enrollment and 24-month follow-up) 
Primary Safety 
Endpoint: 
Major Adverse Clinical Events (MACE) at 6 months.   MACE is a composite endpoint 
defined as: 
1. 
Death 
2. 
Target limb amputation 
3. 
Target vessel revascularization (TVR) 
4. 
Major bleeding (transfusion of >2 units PRBC) 
5. 
Deep vein thrombosis on ipsilateral limb 
Primary 
Performance 
Endpoint: 
The rate of primary patency at 6 months. 
Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the 
stent graft or immediately above or below the treated arterial segment based on duplex 
ultrasound (systolic velocity ratio of >2.5). 
The primary effectiveness endpoint will be assessed by an independent Core Lab. 
Secondary Safety 
Endpoints: 
Major Adverse Clinical Events (MACE) will be evaluated at: 
1. 
Discharge 
2. 
12 months 
3. 
18 months 
4. 
24 months 
Secondary 
Effectiveness 
Endpoints: 
• 
Technical Success defined as:  successful delivery, access and placement of the 
investigational devices and successful removal of delivery system. 
• 
Procedural Success defined as: successful delivery, access and placement of the 
investigational devices in the absence of in-hospital MACE. 
• 
Clinical Success defined as improvement of at least one category using the 
Rutherford Clinical Severity Scale through follow-up. 
• 
The rate of primary assisted patency through follow-up defined as: revascularization 
of non-occlusive (<99%) stenosis within the stent graft or immediately above or 

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below the treated arterial segment with less than 50% residual stenosis. 
• 
The rate of secondary patency through follow-up defined as: revascularization of 
occlusion (100%) within the stent graft or immediately above or below the treated 
arterial segment with less than 50% residual stenosis. 
DSMB 
A Data Safety Monitoring Board (DSMB) consisting of non-Investigator experts, will review 
safety data from the study and establish stopping rules for early termination of the trial. The 
DSMB will make recommendations based upon the safety analysis of adverse events, 
protocol deviations, and device failures.  The DSMB will function in accordance with SOPs 
and applicable regulatory guidelines.  
CEC 
A Clinical Events Committee will review and adjudicate primary and secondary safety 
endpoints (including major adverse events), serious adverse events and device related 
adverse events. 
Inclusion Criteria: 
• 
Willing and able to provide informed consent 
• 
Age 18 or older 
• 
Rutherford Classification of 3-5 
• 
Patent iliac and femoral arteries/veins and access vessels, of sufficient size and 
morphology (including tortuosity), to allow endovascular access with 8 Fr. introducer 
sheath 
• 
Femoro-popliteal lesions ≥10 cm in length considered to be: 
o 
Chronic total occlusion (100% stenosis) 
o 
Diffuse stenosis (>50% stenosis) with moderate to heavy calcification 
o 
In-stent restenosis (>50% stenosis) 
• 
Proximal and distal target vessels are 5.4-7.0 mm in diameter 
• 
Orifice and proximal 1 cm of SFA is patent 
• 
Patent popliteal artery 3 cm proximal to tibial plateau 
• 
At least 1 patent tibial artery to the foot 
• 
Patent femoral vein ≥ 10 mm in diameter or duplicate femoral vein 
• 
Subject has > one-year life expectancy 
Exclusion Criteria: 
• 
Age greater than 90  
• 
Bypass length required > 30 cm 
• 
History of deep vein thrombosis 
• 
Has known hypersensitivities, allergies or contraindications to: nitinol, PTFE; aspirin, 
heparin, antiplatelet, anticoagulant or thrombolytic therapy; or anticoagulation or 
contrast media  
• 
Has a known history of intracranial bleeding or aneurysm, myocardial infarction or 
stroke within the last 3 months 
• 
Pregnant or nursing 
• 
Untreated flow-limiting aortoiliac occlusive disease 
• 
Has renal failure (eGFR < 30mL/min) 
• 
Major distal amputation (above the transmetatarsal) in the study or non-study limb 
• 
Patient has had a revascularization procedure on the target limb within 30 days of the   
planned index procedure  
• 
Patient has a planned amputation of the target limb 
• 
Previous bypass surgery on the target limb 
• 
Patient is participating in another clinical study for which follow-up is currently on 
going 

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• 
Patient has a condition that in the view of the investigator precludes participation in 
this study 
Follow-Up: 
• 
Discharge 
• 
30 days ± 7 days (optional, per physician practice) 
• 
3 months ± 14 days 
• 
6 months ± 30 days 
• 
12 months ± 45 days 
• 
18 months ± 45 days 
• 
24 months ± 60 days 
 
The CE Mark study commenced in January 2015, in Riga, Latvia (Site 01), where the first 
two patients were enrolled.  As of May 2016, 60 subjects have been treated at 7 sites and 
have been followed through 6 months.  Of the first 60 subjects treated, 35 have completed 
follow up through 12 months. Enrollment and follow up through 24 months is ongoing.   
 
Baseline demographics and lesion characteristics for the first 60 subjects treated in STP 115 
are provided below in Table 6.  As noted in the inclusion exclusion criteria, the population 
being treated involves TASC C/D long lesions (avg. = 28.6 cm, 93.3% TASC D) including a large 
proportion (96.7%) of CTOs.   
 
 
 

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primary patency outcomes in TASC D lesions as reported in the literature.  As 97% of the PQ 
Bypass study subjects had TASC II D lesions, only published literature which reported 
outcomes of TASC D lesions were included.  
 
As presented below in Table 15 the weighted average 12 month primary patency rate of TASC 
D lesions treated with the Viabahn Endoprosthesis, as reported in the literature, was 69.1%.  
As a reminder, the 12 month primary patency rate in the PQ Bypass study in 35 lesions is 
82.7% (29/35). 
 
Table 15:  Primary Patency at 12 Months in TASC D Lesions Treated with the Viabahn 
Endoprosthesis as Reported in the Literature  
Lead Author - Year 
Number of 
TASC D 
Lesions 
Viabahn 12 Month  
Primary Patency  
TASC D Lesions 
(%) 
Schneider_20111 
20 
68.0% 
Lensvelt_20127 
33 
69.7% 
12M N 
53 
69.1% 
(Weighted Average)  
 
PQ Bypass 12 month primary patency results were then compared to outcomes of surgical 
bypass with a synthetic graft as reported in the literature.  As the PQ Bypass study treated 
long TASC D lesions (mean 28.7 cm with 97% TASC D), only published literature which 
reported outcomes of either a) lesions with a mean lesion length > 18 cm or b) a substantial 
(>50%) proportion of TASC D lesions, were included.  
 
As presented below in Table 16, 12 month primary patency rates in long lesions treated with 
synthetic stent grafts, as reported in the literature, ranged from 76% to 88.0%.  As a reminder, 
the 12 month primary patency rate in the PQ Bypass study in 35 lesions is 82.7% (29/35), 
which is in line with the patency results of bypass surgery with synthetic grafts. 
 
It should be noted that none of the articles report outcomes for TASC II D lesions separately.  
Primary patency results for exclusively TASC D lesions are expected to be lower than in 
articles which combine TASC II A, B, C and D lesions (McQuade et al5) or TASC II C and D lesions 
(Linnakoski et al8 and Dosluoglu et a 9).  Therefore, the patency rates presented below are 
assumed to be an overestimation of primary patency rates in exclusively TASC II D lesions.  
 
                                                            
7 Lensve t MM(1), Fr tschy WM, van Oostayen JA, Ho ew jn S, Zeebregts CJ, Re jnen MM.  Resu ts of hepar n bonded ePTFE covered 
stents for chron c occ us ve superf c a  femora  artery d sease.  J Vasc Surg. 2012 Ju ;56(1):118 25. 
8 L nnakosk  H, Uurto I, Suom nen V, Vakh tov D, Sa en us J.  Compar son of above-the-knee prosthet c femoro-pop tea  bypass versus 
percutaneous trans um na  ang op asty and stent ng for treatment of occ us ve superf c a  femora  artery d sease.  Scand J Surg. 
2013;102(4):227-33. 
9 Dos uog u HH, Cherr GS, La  P, Harr s LM, Dryjsk  ML.    Stent ng vs above knee po ytetraf uoroethy ene bypass for TransAt ant c 
Inter-Soc ety Consensus-II C and D superf c a  femora  artery d sease.  J Vasc Surg. 2008 Nov;48(5):1166-74. 

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Table 16:  Synthetic Surgical Bypass Vascular Graft Lit Search – Effectiveness Outcomes 
Lead Author - Year 
Synthetic Surgical Bypass 
12 Month  
Primary Patency  
(%) 
Dosluoglu_20089 
81.0% 
McQuade_2010 
76.0% 
Linnakoski_2013 
88.0%  
1 Estimated from Kaplan-Meier (or Life-Table) curves. 
 
Summary 
In summary, MAE rates at 30 days and 12 months for subjects treated in the PQB 4 FP II Study 
compare favorably to MAE rates for the Viabahn stent graft in long and/or TASC D lesions as 
reported in published literature (Table 17 below).  Thirty day and 12 month MAE rates for 
initial subject in the PQ Bypass Study of 3.4% and 14.3% while MAE rates for the Viabahn 
Endoprosthesis range from 0.0% to 11.1% at 30 days and 32.5% to 50% at 12 months.  
 
Table 17: PQ Bypass 30 Day and 12 Month MAE Rates as Compared to Viabahn  
as Reported in the Literature 
Lead Author - Year 
30 Day  
MAE Rate1 
(%) 
12-Month  
MAE Rate1  
(%) 
Schneider_2011 
11.1% 
N/A 
Saxon_2013 
0.8% 
N/A 
Lammer_2013 
1.3% 
N/A 
Zeller_2014 
0.0% 
N/A 
McQuade_2010 
N/A 
32.5% 
Johnston_2012 
N/A 
50.0% 
PQ Bypass Study 
0.0%  
(0/35) 
14.3%  
(5/35) 
1 Total MAE is a sum of the individual events and therefore may slightly overestimate the actual MAE rate, as 
individual patients may have had multiple MAE. 
N/A = Not applicable. 
 
The 12 month primary patency rate for subjects treated in the PQB 4 FP II Study as compared to 
long and/or TASC D lesions treated with stents, stent grafts (Viabahn) and bypass surgery with 
synthetic grafts as reported in either SSEDs or in published literature are presented in  

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Table 18Table 18 below.   
 
The 12 month primary patency rate in the PQB 4 FP II Study of 82.9% compares favorably to 
primary patency rates of: a) stent and stent grafts as reported in SSEDs in long (>15 cm) 
lesions (52.7% weighted average), b) the Viabahn stent graft in TASC D lesions as reported in 
the literature (69.1% weighted average), and c) synthetic surgical bypass grafts in TASC D 
lesions as reported in the literature (range from 76% to 88%).  The 12 month primary patency 
rate in the PQB 4 FP II Study of 82.9% was achieved in lesions that were, on average, longer 
than the average lesion length reported in both SSED and the literature, and included a much 
higher proportion of TASC D lesions (97%) than reported in both SSEDs and the literature.  
Hence, favorable 12 month patency rates were achieved in complex femoropopliteal lesions. 
 
Also, improved patency rates are expected as operators gain experience with the device. 
 
 
 

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Figure 5: PQ Bypass Stent Graft Encapsulated in ePTFE 
 
  
The SG frame is a nitinol (NiTi) wire formed structure. It is made from a single 0.008” 
diameter NiTi wire that is shape set and electropolished. The NiTi frame is wrapped in a 
helical, sinusoidal pattern with seven (7) crowns per revolution. To maintain flexibility when 
covered, the frame has a compression gap between adjacent helical wraps to achieve the 
required flexibility. Each crown has a radius with varying crown length based on the 
diameter of the stent graft. 
 
Figure 6: NiTi Wire Frame (pictured on a process mandrel) 
 
The NiTi wire frame is encapsulated by the ePTFE material. Due to the frame design, the 
cover could be applied to both the inner and outer lumen and still maintain flexibility and 
compressibility. The inner and outer lays of the Cover are thermally laminated together.  
 
ePTFE is a commonly used stent graft material and is considered the ‘material of choice’ for 
grafts.   It is currently used in the Gore Viabahn endovascular stent graft as well as a number 
of AAA stent grafts: 
• Endologix  Powerlink/ AFX 
• Trivascular – Ovation 
• Gore – Excluder 
The PQ Bypass supplier of ePTFE is Zeus Industrial Products, Inc. the same supplier as for the 
Endologix AAA stent grafts.  The Stent Graft is available in lengths of 100, 150 and 200 mm 
(Table 19 and Table 20).  
 
 
 

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4.0 
PROPOSED INTENDED USE 
 
The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment 
of patients with symptomatic de novo or restenotic native lesions or occlusions of the 
superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel 
diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm. 
 
 

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5.0 
STUDY DESIGN 
5.1 
Study Design 
Prospective, single arm, multi center, international, non randomized, pre market, safety 
and effectiveness clinical investigation.    
 
5.2 
Study Endpoints 
Primary Safety Endpoint: 
The primary safety endpoint for this study is freedom from a major adverse event (MAE) at 
30 days post procedure.  An MAE is defined as TLR, amputation of the treated limb, or 
death.  
 
Primary Effectiveness Endpoint: 
The primary effectiveness endpoint is defined as stent patency as evidenced by a peak 
systolic velocity ratio (PSVR) < 2.5 from DUS obtained within the 12 month visit window 
with no clinically driven re intervention within the stented segment.   
 
Secondary Safety Endpoints: 
Secondary safety endpoints will be evaluated and include:  
1. The combined rate of death at 30 (±7) days, target lesion revascularization (TLR), 
index limb amputation, and an increase in Rutherford Becker Classification by 2 
classes (comparing pre  to post procedural assessments) at 12 months.  
2. Major adverse vascular event (MAVE) at 30 days, 6 months (180 ± 14 days) and 12 
months (360 ± 30 days) defined as stent thrombosis, target limb amputation, clinically 
apparent distal embolization, defined as causing end organ damage (e.g. lower 
extremity ulceration, tissue necrosis, or gangrene), procedure related arterial 
rupture, acute limb ischemia, or bleeding event requiring transfusion. 
3. The combined rate of serious procedural adverse events, including death, myocardial 
infarction, index limb amputation, and access site and treatment site complications 
requiring surgery, blood transfusion (>2 units of PRBC), or prolonged hospital stay 
within 30 days of the index procedure. 
Secondary Effectiveness Endpoints: 
1. Acute technical (lesion) success, procedural success and device success.   
2. Ankle Brachial Index (ABI) and Toe Brachial Index (TBI) at 1, 6 and 12 months.   
3. Target vessel revascularization (TVR) at 6 and 12 months.   
4. Limb ischemia by Rutherford Becker Classification at Baseline, 1, 6, and 12 months.  
5. Number of any type of index limb amputations at 6 and 12 months.   
6. Absolute Claudication Distance as measured by the Exercise Tolerance Test (TASCII) 
assessed in 100 subjects at baseline, 1, 6, and 12 months.  
7. Target lesion revascularization (TLR) at 1, 6 and 12 months. 

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8. The rate of primary assisted patency through follow up defined as: revascularization 
of non occlusive (<99%) stenosis within the stent graft or immediately above or below 
the treated arterial segment with less than 50% residual stenosis. 
9. The rate of secondary patency through follow up defined as: revascularization of 
occlusion (100%) within the stent graft or immediately above or below the treated 
arterial segment with less than 50% residual stenosis. 
 
Additional Secondary Endpoints: 
The following additional endpoints will also be reported: 
1. A combined rate of death at 30 days, or TLR, index limb amputation, and an increase in 
Rutherford Becker Classification by 2 classes (comparing pre  to post procedural 
assessments) measured at 24 months.  
2. Target vessel revascularization (TVR) at 24 months post procedure.  
3. Limb ischemia improvement by Rutherford Becker (improvement in scale by ≥ 1) at 24 
months.  
4. Major Adverse Vascular Event (MAVE) by 24 months, defined as: Stent thrombosis, target 
limb amputation, or clinically apparent distal embolization, defined as causing end organ 
damage (e.g. lower extremity ulceration, tissue necrosis, or gangrene).   
5. Procedure related arterial rupture, acute limb ischemia, or bleeding event requiring 
transfusion. Number of any type of index limb amputations at 24 month follow up.  
Target lesion revascularization (TLR) at 24 months post procedure. 
 
5.3 
Study Duration 
This study is expected to commence enrollment in the first quarter of 2016. Enrollment 
of all subjects is expected to be completed in the second quarter of 2016.  
 
5.4 
Number of Subjects and Sites 
 
 Up to 65subjects may be enrolled.  A total of 60 evaluable subjects with a documented 
untreated, atherosclerotic lesions of the native superficial femoral artery (SFA) or the 
superficial femoral and proximal popliteal arteries, suitable for treatment with PQ 
Bypass™ Stent Graft System.  
 
5.5 
Inclusion Criteria 
The subject must meet all of the following criteria at the time of eligibility: 
1. Age ≥ 18 years and of age of legal consent.  
2. Women of child bearing potential must have a negative pregnancy test within 7 days 
prior to the index procedure.  
3. Subject has lifestyle limiting claudication or rest pain (Rutherford Becker scale 2 4*) 
with a resting ABI < 0.9.  Resting TBI is utilized only if unable to reliably assess ABI. TBI 
must be <0.7.  These assessments are required for the target limb, but both limbs are 
preferred.  
4. A superficial femoral artery lesion with >50% stenosis or occlusion which requires 
treatment.   

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5. Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial 
lesions) ≥ 80mm to ≤ 180mm.  
6. Reference vessel diameter (RVD) ≥ 5.0mm and ≤ 6.7 mm, angiographically/CTA/MRA 
defined. 
7. Patent popliteal artery 3 cm proximal to tibial plateau  
8. At least 1 patent tibial artery to the foot (<50% stenosis) 
9. The target lesion(s) can be successfully crossed with a guide wire and dilated.  
10. Adequate aortoiliac or common femoral “inflow” is defined as <30% stenosis after 
either PTA or stenting of the inflow lesion.  After treatment of the inflow lesion, the 
residual pressure gradient across the target lesion will be obtained and if the peak to 
peak pressure gradient is < 20mmHg, the subject will be included in the study.  Subjects 
enrolled with aortoiliac or common femoral artery lesions resulting in poor inflow, 
must be treated prior to receiving the study treatment. (Same Day or earlier) 
11. If a subject has bilateral obstructive SFA disease, only 1 leg may be treated with the 
investigational device in the study.  
a. 
If the study leg is treated first, the contra lateral procedure should not be 
performed until at least 30 days after the index procedure (staged); and should 
only be performed with an approved (CE Marked) device. 
b. 
If the contra lateral leg is treated with an approved (CE Marked) device prior to 
treatment of the study leg, treatment of the contra lateral leg should be 
performed at least 15 days prior to the treatment of the study leg.  
12. The subject is eligible for standard surgical repair, if necessary.  
13. A subject who requires a coronary intervention should have it performed at least 30 
days prior or 30 days post the treatment of the target lesion.  
14. Subject must provide written informed consent.  
15. Subject must be willing to comply with the specified follow up evaluation schedule. 
 
*Note – Patients with stage 2 Rutherford classification can be included when conservative 
physical and drug therapy have been unsuccessful and documented. 
 
5.6 
Exclusion Criteria 
 
The following must NOT be present at the time of subject eligibility:  
1. Age greater than 90 
2. Thrombophlebitis, within the previous 30 days.  
3. Receiving dialysis or immunosuppressant therapy within the previous 30 days.  
4. Thrombolysis of the target vessel within 72 hours prior to the index procedure, 
where complete resolution of the thrombus was not achieved.  
5. Stroke within the previous 90 days.  
6. Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery. 
7. Required stent placement via a popliteal approach.  
8. Procedures which are pre determined to require stent in stent placement to obtain 
patency, such as in stent restenosis.  
9. Significant vessel tortuosity or other parameters prohibiting access to the lesion or 
90° tortuosity which would prevent delivery of the stent device.  
10. Required stent placement within 1 cm of a previously deployed stent.   
11. Known allergies to any of the following: aspirin and clopidogrel bisulfate (Plavix®), 

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ticlopidine (Ticlid ®), and prasugrel (Effient®); heparin; Nitinol (nickel titanium); or 
contrast agent, that cannot be medically managed.  
12. Presence of thrombus prior to crossing the lesion.  
13. Known or suspected active infection at the time of the procedure.  
14. Use of cryoplasty, laser, or atherectomy devices in the target vessel at the time of 
index procedure.  
15. Restenotic lesion that had previously been treated by atherectomy, laser or 
cryoplasty within 3 months of the index procedure.  
16. History of neutropenia, coagulopathy, or thrombocytopenia that was unexplained 
or is considered to be at risk for reoccurrence.  
17. Known bleeding or hypercoagulability disorder or significant anemia (Hb<8.0) that 
cannot be corrected.  
18. Subject has the following laboratory values: a. platelet count less than 80,000/μL, b. 
international normalized ratio (INR) greater than 1.5, c. serum creatinine level 
greater than 2.0 mg/dL.  
19. Subject requires general anesthesia for the procedure.  
20. Major distal amputation (above the transmetatarsal) in the study or non study limb. 
21. Patient has had a revascularization procedure on the target limb within 30 days of 
the planned index procedure  
22. Patient has a planned amputation of the target limb 
23. Previous bypass surgery on the target limb 
24. Subject is pregnant or plans to become pregnant during the study.  
25. Subject has a co morbid illness that may result in a life expectancy of less than 1 
year.  
26. Subject is participating in an investigational study of a new drug, biologic or device 
at the time of study screening.   
 
 
 

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6.0 
SUBJECT ENROLLMENT INFORMATION 
6.1 
Written Informed Consent 
 
Subjects who meet general entry criteria will be asked to sign the study specific Ethics 
Committee (EC) approved Informed Consent form before any study specific tests or 
procedures are performed. Study personnel should explain that even if a subject agrees to 
participate in the study and signs an Informed Consent Form, the subject may not be eligible 
to participate if he/she fails screening criteria. 
 
A Screening/Enrollment Log will be maintained to document select information about 
candidates who fail to meet the entry criteria. 
 
6.2 
Enrollment 
Subjects will be considered enrolled into the study once informed consent has been signed 
and all eligibility criteria confirmed. Investigators will access the target artery using standard 
percutaneous techniques and devices. Patient eligibility will be confirmed prior to insertion 
of the study device, based on procedural angiogram, sheath placement and wire placement 
across lesion followed by dilatation. 
 
6.3 
Duration of Subject Participation 
 
Subjects enrolled in the trial will participate for approximately 24 months. 
 
6.4 
Withdrawal of Subjects 
 
Each subject may voluntarily withdraw his/her participation from the study at any time. 
Investigators may discontinue a subject’s participation in the study as deemed appropriate 
per safety measures and/or if the subject’s medical condition contraindicates further study 
participation. All enrolled subjects will undergo the complete study follow up for safety 
evaluation. 
 
6.5 
Lost to Follow-Up 
A subject will be considered lost to follow up and terminated from the study when all of the 
following criteria have been met: 
•Documentation of three unsuccessful attempts on three different days over a period 
of three (3) months by the Investigator or his/her designee to contact the subject or 
next of kin, one of which should be by certified mail with signature confirmation. 
•Prior agreement of the Sponsor to remove the subject from the clinical investigation 
 
6.6 
Subject Confidentiality 
All information concerning subjects in this trial will be considered confidential. Only 
authorized PQ Bypass personnel and designated consultants and regulatory agencies will 

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have access to these confidential files. Enrolled subjects will be assigned a unique 
identifier that will be used to maintain confidentiality of each subject’s medical 
information. Subject names and other protected health information will not be captured 
on the case report forms. In addition, angiographic and ultrasonic images submitted from 
the participating site to the Sponsor or angiographic reviewers for analysis should be 
redacted. 
 
 
 

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7.0 
RISK-BENEFIT ASSESSMENT 
7.1 
Risks 
There are standard risks associated with any interventional procedure or stent graft 
placement as well as risks specific to the PQ Bypass devices and procedure. Risks associated 
with any interventional procedure include access site hemorrhage or hematoma, access site 
pain, acute vessel closure, infection, renal insufficiency/failure due to excessive contrast 
load, and death.  
 
Possible risks related to the PQ Bypass Stent Graft System include, but are not limited 
to, the following: thrombosis, stenosis or occlusion, aneurysm or pseudoaneurysm 
formation, vessel dissection, perforation or wall trauma, embolism, edema or phlebitis), 
arteriovenous fistula formation, bleeding infection or side branch occlusion. Adverse events 
are enumerated noted in Section 12 below. 
 
Additionally, subjects will be exposed to risks associated with conscious sedation, use of 
radiographic contrast and procedural medications. Subjects will be asked to take anti
platelet medication for this study, such as aspirin, Plavix (clopidogrel)). These medications 
have been approved to reduce the risk of cardiovascular events. An Investigator will discuss 
with each subject the standard risks associated with these medications. 
 
7.2 
Risks Minimization 
Risk Management of the PQ Bypass Stent Graft System follows a systematic approach to 
failure analysis, which includes both identification and mitigation of failure modes per ISO 
14971 Medical Devices — Application of Risk Management to Medical Devices. Potential risk 
or failure mode identification will be assessed through the following tools, all of which are 
part of design history file: 
 
• Device Characteristics Survey 
• Hazard Analysis 
• Design Failure Mode Effect Analysis (dFMEA) 
• Process Failure Mode Effect Analysis (pFMEA) 
• Risk Management Plan/Report 
 
As part of each assessment, risks based on severity and probability are calculated for each 
potential failure mode. Potential failure modes having risks above a specified limit are 
mitigated and verified as a result of design changes, continued analyses, testing, and/or 
monitoring. For the risks that remain, protection appropriate to each risk is provided to 
minimize the hazard from potential device failures. Any possible adverse effect of the device 
constitutes an acceptable risk when weighed against the benefits to the subject and the risk 
is compatible with a high level of protection of health and safety. Results of the risk analysis 
demonstrate that use of the device as intended does not adversely affect the health or safety 
of the subject, user, or other person(s). 
 

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Additional efforts to minimize risk include the following: 
• Clearly defining the subject inclusion/exclusion criteria. 
• Selecting only qualified, experienced Investigators trained in the 
endovascular treatment of vascular disease who have participated in an 
extensive training program to assure thorough proper technique. 
• Careful review of the dimensional specifications of each subject’s anatomy 
and surrounding vasculature, including the peripheral vasculature to ensure 
that the subject’s is anatomically appropriate for treatment with the PQ 
Bypass Stent Graft and that access can be achieved through the peripheral 
vasculature. 
• Attending to proper vascular access technique to minimize the trauma to 
vascular structures. 
• Ensuring that treatment and follow up of subjects is consistent with 
standard and current medical practice. 
• If the Investigator determines that an adverse event is sufficiently severe to 
remove the subject from the study, a termination assessment will be 
performed and PQ Bypass will be notified. The subject will then be given 
appropriate treatment under medical supervision. 
 
Risk will be mitigated by working with Investigators who are experienced and skilled in 
endovascular techniques including use of re entry tools and stent graft placement. 
Additionally, each Investigator will be thoroughly trained on proper device operation prior 
to device use. Risks will also be minimized in this study by adhering to the 
inclusion/exclusion criteria. For example, subjects with known allergies or contraindications 
to study medications (contrast, anti platelet) will be excluded. Risks associated with device 
malfunctions or failures will be minimized through bench and in vivo animal verification and 
validation testing prior to use in this study. 
 
7.3 
Benefits 
Endovascular treatment of peripheral arterial disease (PAD) obviates the need for peripheral 
surgery and associated complications by using the stent/stent graft as a means of intra
arterial revascularization of TASC A C lesions. Endovascular treatment can be performed 
safely resulting in lower morbidity and lower mortality rates than those of open surgical 
repair. Benefits include, but are not limited to: 
 
• Absence of surgical incision/cut down 
•  Faster recovery, shorter hospital stay 
• No requirement for general anesthesia in some cases 
• Less post procedure pain 
• Fewer complications 
 
Subjects included in this study have lesions (TASC B and C) that are commonly treated with 
conventional endovascular means, including stent grafts. Based on previous treatments 
using commercially available devices, bench and animal testing and reported outcomes in 
the ongoing more challenging Bypass approach CE mark study (STP 115), it is expected that 
the participants in this study will have their lesions successfully treated without the need for 

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surgery or additional risk relative to other endovascular procedures. 
The PQ Bypass Stent Graft System may allow physicians to treat challenging lesions in the 
femoral artery percutaneously, thereby avoiding the risks and morbidity of more invasive 
procedures such as surgical bypass or amputation. 
 
 

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8.0 
STUDY PROCEDURE 
8.1 
Vascular Access and Guidewire Delivery 
Investigators will access the target lesion using standard percutaneous techniques and 
devices. Patient eligibility will be confirmed prior to insertion of the study device, based on 
procedural imaging, sheath placement and wire crossing the lesion.  
 
8.2 
Stent Graft Placement 
Stent Grafts (SGs) of appropriate dimension are selected based on the instructions provided 
in the Stent Graft System IFU (Appendix II). After placement, the Investigator uses a 
standard balloon dilation catheter to complete stent deployment, ensuring that the balloon 
is only inflated within the SGs’ lumen. 
 
8.3 
Follow-Up 
 
Subjects will return to the study center at 1 month, 6 months, 12 months, and 24 months 
following the procedure for a follow up evaluation.  The subject will undergo lower
extremity arterial ultrasounds, and examined for any post procedural complications or 
adverse events.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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9.0 
MATERIALS AND METHODS 
Safety and performance evaluations will be conducted throughout the study.  Such 
evaluations will be conducted on the case report forms. 
 
9.1 
Initial Eligibility 
After subjects have signed an informed consent form and before the scheduled 
interventional procedure, subjects will undergo an initial eligibility evaluation. This 
evaluation may be conducted from an office visit within the previous 90 days. The evaluation 
is described in the schedule of events table.  
 
9.2 
Baseline Evaluation 
After subjects have signed an informed consent form and before the scheduled 
interventional procedure, subjects will undergo a baseline evaluation. This evaluation may 
be conducted from an office visit within the previous 30 days. The evaluation is described in 
the schedule of events table.  
9.3 
Procedural Evaluation 
Final eligibility will be determined based on imaging study and sheath placement. 
Information on the lesion being treated and the specific vasculature used in its treatment 
will be collected. The evaluation is described in the schedule of events table.  
 
9.4 
Discharge Evaluation 
The discharge evaluation is described in the schedule of events table. CK at discharge is to 
be obtained only if subject shows signs or symptoms of cardiac ischemia.  CK MB is required 
if CK is elevated (≥ 2X the laboratory upper limit of normal). 
 
9.5 
Follow-Up Evaluation 
A follow up evaluation will be conducted at 30 day, 6 months, 12 months and 24 months 
following the procedure or when a subject withdraws prematurely.  The evaluation is 
described in the schedule of events table.  
 
Patients will be exited from the study after the last trial visit and will undergo further follow
up at the discretion of their treating physician per the standard of care.  It is however 
recommended that a doppler ultrasound be performed at least annually post study exit 
through 5 years (additional 3 years post follow up) for monitoring purposes. A further 
recommendation is to maintain dual antiplatelet therapy (Aspirin and Plavix) indefinitely. An 
information sheet will be provided to the patient upon study exit that contains these 
recommendations for the treating physicians.  
 
Patients will be provided an implant card at the time of hospital discharge that contains the 
patient´s name, device name, device model number, serial number of the implant, 

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manufacturer’s information, date of implantation, and facility at which the implantation was 
carried out. 
10.0 
INVESTIGATIONAL DEVICE DISTRIBUTION AND ACCOUNTABILITY 
10.1 
Device Accountability 
The Investigator shall maintain adequate records of the receipt and disposition of all 
investigational devices. The Investigator is responsible for ensuring that the investigational 
devices are used only under the Investigator’s supervision and are only used according to 
this protocol and any approved amendments. The Investigator will not supply an 
investigational device to any person not authorized to participate in the study. The 
Investigator shall document in CRFs the lot numbers of the devices used during a case. In 
addition, the Investigator shall keep complete and accurate records of all devices used or 
unused that have been turned to PQ Bypass in a Device Accountability Log provided by PQ 
Bypass. 
 
10.2 
Return of Devices 
All unused investigational devices will be returned to the study Sponsor upon completion 
of the clinical study. All used investigational devices will be properly disposed of, per 
institutional procedures. Any investigational device that fails to perform correctly will be 
returned to the study Sponsor for analysis. The Investigator or his/her designated 
representative is responsible for device accountability and disposition of all used and 
unused devices. The study Sponsor or its designated representative will conduct device 
reconciliation at the completion of subject enrollment or at the conclusion of the study. 
 
 

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11.0 
ENDPOINTS AND STATISTICAL ANALYSIS PLAN 
11.1 
Endpoints Analyses and Reporting of Results 
The study objective is to assess the safety and performance of the PQ Bypass Stent Graft 
System to access, deliver guidewires and implant stent grafts.  The statistical methods for 
the primary endpoints are pre specified in this analysis plan and cannot be changed at the 
time of analysis. 
 
 
All subjects will be followed on an intent to treat basis.  The device performance will be 
assessed based on a per protocol analysis of the primary safety and effectiveness endpoints.  
An Intent to treat analysis, along with other secondary analyses, will also be completed and 
reported. Demographic, baseline clinical and disease characteristics, procedural results and 
primary, secondary and all additional endpoints will be summarized using descriptive 
statistics.  All statistical analyses will be performed using SAS for Windows version 9.1 or 
higher. 
 
As noted above, up to 65 subjects with a documented untreated, atherosclerotic lesions of 
the native superficial femoral artery (SFA) or the superficial femoral and proximal popliteal 
arteries, suitable for treatment with PQ Bypass Stent Graft may be enrolled in the study to 
ensure an appropriate sample size of 60 evaluable subjects post treatment.  
 
§ Safety assessment will be achieved by recording and measuring Major 
Complication rates/Serious Adverse Event rates associated with the PQ Bypass 
stent grafts. The primary safety endpoint (MAE) and MAVE will be presented 
using descriptive statistics at various time intervals. Using the Wilson Method, 
the one sided upper 95% confidence bound will be calculated and presented. 
§ The primary performance hypothesis will be tested by calculating the one sided 
95% lower confidence limit for the rate of successful performance using the 
Wilson Method.  If the lower limit exceeds the performance goal rate of 70% 
the null hypothesis will be rejected and the endpoint will be met. In addition to 
hypothesis testing, descriptive statistics of the primary performance endpoint 
will include the total number and percentage of  patent PQB grafts. 
§ Descriptive statistics of the primary performance endpoint which includes total 
number of patent PQ Bypass grafts, percentage of patent PQ Bypass grafts, and 
the one sided 95% CI of the percentage using the Score approximation will be 
presented.  The lower bound of the one sided 95% CI will be will be calculated 
and presented. 
 
§ The secondary endpoint of primary assisted and secondary patency will be 
summarized using Kaplan Meier survival analysis. Life tables will be created and 
a Kaplan Meier survival curve will be presented.  
 
§ Other secondary endpoints will be summarized by providing point estimates, 

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Table 23 : Superiority with PQ Bypass Performance of 85% 
 
 
 
 
 
 
 
 
However, due to noise in the literature, the fact that the true performance of the PQ Bypass 
Stent Graft is unknown at this time, and potential loss to follow up, a larger sample size is 
required for the Study in order to ensure 50 evaluable subjects taking into account the above 
assumptions. The lower the true performance rate of the PQ Bypass Stent Graft, the greater 
the sample size needed to reject the null hypothesis and maintain 80% power.  Therefore, 
up to 65 subjects may be enrolled. 
 
 
 
PG 
PQ Bypass 
80% 
85% 
90% 
95% 
70% 
119 
50 
26 
15 
75% 
441 
103 
42 
21 
80% 
- 
368 
83 
32 
85% 
- 
- 
283 
60 

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11.2 
Primary Safety Endpoint Reporting 
The primary safety endpoint is the rate of Major Adverse Events (MAEs) at 30 days.  The 
number and percent of subjects that experience at least one MAE through 30 days post
procedure will be reported along with the upper one sided 95% confidence limit.   In 
addition the number and percentage of subjects reporting MAEs and MAVEs will be 
presented using descriptive statistics at various time intervals, combined and by type of 
event. The confidence intervals will be calculated using the Wilson method. 
 
11.3 
Primary Performance Endpoint Reporting: 
The primary performance hypothesis will be tested by calculating the one sided 95% lower 
confidence limit for the rate of successful performance using the Wilson Method.  If the 
lower limit exceeds the performance goal rate of 70% the null hypothesis will be rejected 
and the endpoint will be met. In addition to hypothesis testing, descriptive statistics of the 
primary performance endpoint will include the total number and percentage of  patent 
PQB grafts.  
 
11.4 
Secondary Endpoint Analysis: 
The secondary endpoint of primary assisted and secondary patency will be summarized 
using Kaplan Meier survival analysis. Life tables will be created and a Kaplan Meier survival 
curve will be presented. 
 
The secondary endpoints inclusive of Procedural Success, Clinical Success and Technical 
Success will be summarized by providing point estimates, number of subjects, and 95% 
confidence bounds calculated using the Score approximation. 
 
11.5 
Demographic, procedural and safety data: 
 
Demographic and baseline clinical and disease characteristics will be summarized in tables. 
For continuous variables the summary will include number, mean, and standard deviation 
and 95% confidence intervals. Summaries for categorical variables will include the number 
and percent of subjects in each category. 
11.6 
Imputation for Missing Data 
Imputations for missing data in (e.g. withdrawn subjects, loss to follow up, missing data) will 
not be performed.  Analyses will be performed with all available data only. 
 
 
 

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12.0 
ADVERSE EVENTS 
The occurrence of Adverse Events will be monitored during this study. All Adverse Events 
will be recorded on the Adverse Event Form at onset and at each follow up visit until 
resolved. To meet the objectives of this study, the following definitions will apply. 
(Definitions reference ISO 14155:2011 01). Potential adverse events associated with use 
of the SGS include, but are not limited to the following:  
 
• 
Access site hemorrhage or 
hematoma  
• 
Access site pain/infection  
• 
Acute vessel closure 
• 
Aneurysm or pseudoaneurysm 
formation 
• 
Arteriovenous (AV) fistula  
• 
Death 
• 
Device failure 
• 
Embolism 
• 
Fever/pain in absence of infection 
• 
Infection  
 
• 
Inflammation 
• 
Malposition 
• 
Myocardial infarction 
• 
Radiation injury 
• 
Renal insufficiency/failure due to 
excessive contrast load  
• 
Sepsis 
• 
Shock 
• 
Side branch occlusion 
• 
Stenosis or Occlusion 
• 
Thrombosis 
• 
Vessel dissection, perforation or wall 
trauma 
 
12.1     Adverse Event (AE) 
Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury or 
any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or 
other persons whether or not related to the medical device. This includes events related to 
the device or events related to the procedures involved. 
 
Adverse Device Effect: An adverse event related to the use of a medical device, including 
adverse events resulting from insufficient or inadequate Instructions for Use, deployment, 
implantation, installation or operation, or any malfunction of the medical device or any event 
resulting from user error or intentional misuse of the medical device. 
The Investigator is responsible for assessing the severity of the AE, the causal relationship 
between any events and the clinical study procedure, activities or device. Additionally, the 
Investigator is responsible for providing appropriate treatment for the event and for 
adequately following the event until resolution. The following categories of adverse event 
severity are to be used: 
 
• Mild: Awareness of a sign or symptom that does not interfere with the 
subject’s usual activity or is transient, resolved without treatment and with 
no clinical sequelae. 
• Moderate: Interferes with the subject’s usual activity 
• Serious: Any fatal or immediately life threatening clinical experience that 
requires a subject to be hospitalized, or hospitalization is unduly prolonged 
because of potential disability or danger to life or because an intervention 

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has been necessitated. This includes any permanently disabling event 
 
12.2 
Serious Adverse Event (SAE) 
Serious Adverse Event (SAE): A serious adverse event is any problem or unwanted event 
encountered in a clinical trial or a performance evaluation that has led, could have led, or 
could lead directly or indirectly to death or to a serious deterioration in the health of a 
subject or user or any other person, without regard to whether the event was caused by 
a medical product. (§ 2 no. 5 MPSV). The following events (including laboratory results and 
outcome events) will be considered to be SAEs and must immediately (within 24 hours) be 
reported to the study Sponsor by telephone, fax and/or email. These events must be 
reported whether or not the Investigator believes they are related to study procedures, 
activities or device: 
 
• Death 
• Serious deterioration in the health of the subject, that either resulted in 
a life threatening illness or injury, or a permanent impairment of a body 
structure or a body function, or in patient or prolonged hospitalization, 
medical or surgical intervention to prevent life threatening illness or 
injury or permanent impairment to a body structure or a body function. 
• Malignant Tumor (Austrian Medical Device Act, § 3 Abs.16 MPG as 
amended) 
 
Serious Adverse Device Effect: An adverse device effect that has resulted in any of the 
consequences of a Serious Adverse Event. 
 
Note: Planned hospitalization for a pre existing condition, a condition unrelated to the 
treatment or a procedure required by this study, that is without serious deterioration in 
health, is not considered a serious adverse event. 
 
 
12.3 
Unanticipated Adverse Device Effect (UADE) 
Unanticipated Serious Adverse Device Effect (USADE): Serious adverse device effect which, 
by its nature, incidence, severity or outcome has not been identified in the risk analysis 
report. 
 
Anticipated Serious Adverse Device Effect (ASADE): An effect, which by its nature, incidence, 
severity or outcome has been identified in the risk analysis report. UADEs must be reported 
to the study Sponsor by telephone, fax and/or email within 24 hours. 
 
12.4 
Reporting of Adverse Events 
 
All incidents will be captured as a part of this clinical study. At each contact with the subject, 
the investigator will seek information on adverse device effects by specific questioning 
and, as appropriate, by examination. Information on all adverse device effects will be 
recorded immediately in the source document, and also in the appropriate adverse effect 
case report form (CRF). All clearly related signs, symptoms, and abnormal diagnostic 
procedures results should be recorded in the source document. All SAEs, UADEs and 

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possible device and/or procedure  related adverse events must be recorded on the Adverse 
Event CRF by the Investigator (or his/her designee) and reported to the Sponsor within 24 
hours. The report should include: severity, duration, action taken, treatment outcome and 
relationship to the adverse event to the study device, procedure, concomitant medications, 
pre existing condition, etc. (i.e., unrelated, relation or relationship unknown). 
 
In the case of serious adverse events (SAE), procedure and/or device failures and 
malfunctions, medical record documentation (e.g., procedure notes, operative notes, 
discharge summary, relevant progress notes, imaging or lab studies) must be provided to 
PQ Bypass or its designee, if requested. All SAEs shall be recorded in the CRF and this 
information shall be faxed to the Study Monitor/PQ Bypass. If appropriate, PQ Bypass shall 
inform the Competent Authority and the relevant Ethics Committee about the event within 
the appropriate timelines. 
 
In accordance with MEDDEV 2.7 / 3 rev.3 (May 2015), the sponsor must report: 
 
• 
all reportable events as described in section 4 which indicate an imminent 
risk of death, serious injury, or serious illness and that requires prompt 
remedial action for other patients/subjects, users or other persons or a new 
finding to it, 
• 
to the National Competent Authorities where the clinical investigation has 
commenced, 
• 
Immediately, but not later than 2 calendar days after awareness by sponsor 
of a new reportable event or of new information in relation with an already 
reported event. 
 
12.5 
Reporting of Device Failures and Malfunctions 
All reported device malfunctions or failures of the PQ Bypass Systems are required to be 
documented in the CRF and must be immediately reported to the study sponsor by 
telephone, fax and/or within 24 hours. Device failures and malfunctions should also be 
documented in the subject’s medical record. Instructions for returning the investigational 
device will be provided. 
 
NOTE: Device failures or malfunctions are NOT to be reported as adverse events. However, 
if there is an adverse event that results from a device failure or malfunction, that specific 
event would be recorded in the usual way. 
 
12.6 
Documentation, evaluation and notification of Serious Adverse Events 
The Investigator shall report all serious adverse events (anticipated or unanticipated) to 
Sponsor or Sponsor’s representative within 24 hours upon becoming aware of events.  The 
Sponsor will ensure compliance with all country specific reporting requirements to the 
appropriate Ethical Committees and Competent Authorities. SAEs should be reported 
immediately and no later than 7 days from the Sponsor’s first knowledge of the event. 
 
 

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13.0 
MONITORING 
13.1  
Selection and Qualification of Monitors (ISO 14155) 
Monitors will be appointed by the sponsor. Monitors will be trained with scientific and/or 
clinical knowledge and the sponsor will document his/her qualifications. The Monitor will 
be familiar with the investigational product, protocol, consent form and any other written 
information given to the participant, sponsor’s SOPs, and GCP and the relevant regulatory 
requirements. 
13.2 
Assessment of the Investigation Site (ISO 14155)  
The monitor shall assess each investigation site to verify that the principal investigator has:  
a) adequate qualifications;  
b) adequate resources, including facilities, laboratories, equipment and a qualified 
investigation site team;  
c) access to an adequate number of subjects.  
13.3 
Site Initiation (ISO 14155) 
The monitor shall initiate each investigation site to ensure that the principal 
investigator and investigation site team: 
a) have received and understood the requirements and contents of  
1) CIP,  
2) IB,  
3) the informed consent form,  
4) CRFs,  
5) the instructions for use,  
6) any written clinical investigation agreements, as appropriate,  
b) have access to an adequate number of investigational devices,  
c) have been trained in the use of the investigational device, and  
d) are familiar with the responsibilities of the principal investigator 
13.4 
Interim Monitoring Visit (ISO 14155) 
The monitor shall perform routine on site monitoring visits to verify that  
a) compliance with the CIP, any subsequent amendment(s), this International 
Standard and regulatory requirements is maintained; deviations shall be discussed 
with the principal investigator(s) or authorized designee, documented and reported 
to the sponsor,  
b) only authorized individuals are participating in the clinical investigation,  
c) the investigational device is being used according to the CIP or instructions for use 
and that, where modifications are required to the device, its method of use or the 
CIP,  
 

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these are reported to the sponsor,  
d) investigation site resources, including laboratories, equipment and the 
investigation site team, remain adequate throughout the duration of the clinical 
investigation,  
e) the principal investigator continues to have access to an adequate number of 
subjects and investigational devices,  
f) signed and dated informed consent forms have been obtained from each subject at 
the point of enrolment or before any clinical investigation related procedures are  
undertaken,  
g) source documents and other clinical investigation records are accurate, complete, 
up to date, stored and maintained appropriately,  
h) CRFs and queries are complete, recorded in a timely manner, and consistent with 
source documents,  
i) appropriate corrections, additions or deletions are made to the CRFs , dated, 
explained if necessary and initialed by the principal investigator or by his/her 
authorized designee; the monitor shall not make corrections, additions or deletions 
to the CRFs,  
j) all adverse events and device deficiencies are reported to the sponsor, and all 
serious adverse events and device deficiencies that could have led to a serious 
adverse device effect are reported to the sponsor without unjustified delay,  
k) all serious adverse events and deviations are reported to the EC, if required,  
l) the storage and investigational device accountability are correct and the traceability 
process is being followed,  
m) all other required reports, notifications, applications, submissions and 
correspondence are maintained in the investigator's files and are accurate, complete, 
timely, legible, dated and identify the clinical investigation,  
n) maintenance and calibration of the equipment relevant to the assessment of the 
clinical investigation is appropriately performed and documented, where applicable,  
o) current laboratory normal values, laboratory certifications, accreditations, or other 
validations are present in the investigator's file, if required,  
p) subject withdrawal has been documented; the monitor shall discuss this with the 
principal investigator or his/her authorized designee,  
q) subject non compliance with the requirements stated in the informed consent has 
been documented; the monitor shall discuss this with the principal investigator or 
his/her authorized designee,  
r) the principal investigator and investigation site team are informed and 
knowledgeable of all relevant document updates concerning the clinical investigation, 
and  
s) any corrective and preventive actions, as needed, have been implemented and are 
effective.  
13.5 
Close-Out Visit (ISO 14155) 
A close out visit will be conducted to ensure that the principal investigator’s records are 
complete, all documents needed for the sponsor’s files are retrieved, remaining clinical 
investigation materials are disposed of, previously identified issues have been resolved and 
all parties are notified.  The visit will occur after the last subject’s case report forms have been 

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completed, study has been closed with reviewing IRB/IEC and all regulatory issues have been 
addressed.  
13.6 
Monitoring Reports (ISO 14155) 
All monitoring activities shall be documented in a written report to the sponsor and shall 
include:  
a) the date, investigation site identification, name of the monitor and name of the 
principal investigator or other individuals contacted, and  
b) a summary of what the monitor reviewed and his/her observation(s) with regard 
to the completion of previous action items, significant findings, facts, deviations, 
conclusions, and recommended actions to be taken to secure compliance.   
A copy of the monitoring report or a summary of key findings shall be shared with the 
principal investigator in writing.  
 
 

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14.0 
STUDY ADMINISTRATION 
PQ Bypass will make necessary efforts to ensure that this study is conducted in compliance 
with Good Clinical Practices (GCPs) and all applicable regulatory requirements. 
 
14.1 
Source Documentation 
 
The Investigator must maintain detailed source documents on all trial subjects who are 
enrolled in the trial or who undergo screening. Source documents include subject medical 
records, hospital charts, clinic charts, Investigator’s subject trial files, as well as the results 
of diagnostic tests (e.g., laboratory tests). 
 
The following minimum information should be recorded in the subject’s medical records: 
 
• The date the subject entered the trial and the subject number 
• The trial protocol number and the name of the Sponsor 
• The date that informed consent was obtained 
• Evidence that the subject meets trial eligibility requirements (e.g., medical 
history, trial procedures and/or evaluations) 
• The dates of all trial related subject visits 
• Evidence that required procedures and/or evaluations were completed 
• Use of any concurrent medications 
• Documentation of specific device used, if any 
• Occurrence and status of any Adverse Events 
• The date the subject exited the trial, and a notation as to whether the 
subject completed the trial or was discontinued, including the reason for 
discontinuation 
 
14.2 
Clinical Data Management 
 
Software 
This study will utilize electronic data capture (EDC), allowing the data to be entired directly 
into the computerized system by the clinical site personnel.  The Medrio electronic data 
capture software will be used.  This software was developed and validated by Medrio 
Incorporated.   The specific study set up within the software will be the subject of user 
acceptance testing and is not released for use in the study until it has successfully passed 
this testing.   
 
Security 
Hosting is provided by Medrio Inc. and the data entered on the electronic case report forms 
(eCRFs) along with applicable metadata is transmitted using 128 bit SSL and 1024 bit RSA 
public keys. The server on which the data will be stored resides within a secure data center 
with security guards, electronic access controls and digital video monitoring as well as cisco 
firewalls and advanced intrusion detection/prevention systems.  Access to the study EDC 
system will be limited to authorized users with permission levels granted based on the 
user’s role in the study.  Each user is given a unique user ID and generate their own private 

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password. 
 
Query Management 
Queries are generated and managed within the EDC system. Data checks, including those 
that detect missing or inconsistency entries, will be programmed into the system and will 
automatically be generated upon data entry.  Manual queries may also be generated by the 
monitors, CRAs or data management personnel as necessary.  Sites can respond to an 
automatic system generated query by making an update to the data and/or providing a 
textual response to the query.  Query responses are reviewed and closed out by the 
monitor, CRA or data management personnel. 
 
Database Closure and Export for Analysis 
The primary clinical study report will be generated once all necessary patients have reached 
the primary efficacy follow up of 12 months.  A database snapshot will be taken at this time 
for analysis.  Data will be reviewed per the data snapshot checklist that will list the data 
cleaning activities required.  All data is exported into SAS format for analysis by the study 
statistician and to be archived.  Once all follow up has been completed and the database 
closure checklist completed, the EDC system study data and metadata will be exported and 
archived.  All CRF data will be exported into SAS format for analysis and archive. 
 
14.3 
Criteria for Terminating Study 
PQ Bypass reserves the right to terminate the study at any time, but intends only to exercise 
this right for valid scientific or administrative reasons related to protection of subjects. 
Investigators and associated EC and CA will be notified in writing in the event of termination. 
 
Possible reasons for study termination include: 
 
• The discovery of an unexpected, significant, or unacceptable risk to the 
subjects enrolled in the study 
• A decision on the part of PQ Bypass to suspend or discontinue development 
of the device 
 
14.3 
Criteria for Suspending/Terminating a Study Center 
PQ Bypass reserves the right to stop the screening of subjects at a study center at any time 
after the study initiation visit if no subjects have been enrolled or if the center has multiple 
or severe protocol violations without justification or fails to follow remedial actions. 
 
Possible reasons for suspending/terminating a study center include, but are not limited to: 
 
• Repeated failure to complete case report forms prior to scheduled 
monitoring visits 
• Failure to obtain written Informed Consent 
• Failure to report SAEs/UADEs to PQ Bypass within 24 hours of knowledge 
• Loss of (or unaccounted for) investigational product inventory 
 

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14.4 
Data Safety Monitoring Board (DSMB) 
A Data Safety Monitoring Board (DSMB) consisting of non Investigator experts, will review 
safety data from the study and establish stopping rules for early termination of the trial.  The 
composition of the DSMB will include at least one statistician and at least two clinicians with 
expertise in the treatment interventional peripheral disease.  Names of the actual members 
will not be announced.  The frequency of the DSMB meetings will be determined in 
conjunction with the Sponsor.  However, the DSMB may call a meeting at any time if there 
is reason to suspect safety is an issue.   
The DSMB will make recommendations based upon the safety analysis of adverse events, 
protocol deviations, and device failures.  The DSMB will function in accordance with SOPs 
and applicable regulatory guidelines. 
The DSMB chairperson will notify PQ Bypass by confidential memo, of any safety or 
compliance issues. They will also provide confidential recommendations, when necessary, 
of study termination based upon the safety stopping rules determined at study onset, or 
because a clinically significant result was identified in safety analyses of the data.  All DSMB 
reports will remain strictly confidential, but will be made available to regulatory authorities 
upon request. 
 
 

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15.0 
PROTOCOL DEVIATIONS 
A protocol deviation is defined as an event where the Investigator or site personnel did not 
conduct the study according to the protocol. 
 
Investigators shall be required to obtain prior approval from PQ Bypass Clinical Director 
before knowingly deviating from the protocol, except where necessary to protect the life or 
physical well being of a subject in an emergency. Such approval shall be documented in 
writing and maintained in clinical study management and Investigator files. Prior approval is 
generally not expected in situations where unforeseen circumstances are beyond the 
Investigator’s control, (e.g., subject was not available for scheduled follow up office visit, 
blood sample lost by laboratory, etc.); however, the event is still considered a deviation and 
will be reported via the appropriate CRF. 
 
Deviations must be reported to PQ Bypass regardless of whether medically justifiable, pre  
approved by PQ Bypass or taken to protect the subject in an emergency. Subject specific 
deviations will be reported on the Protocol Deviation case report form. Non subject specific 
deviations, (e.g., unauthorized use of an investigational device outside the study, 
unauthorized use of an investigational device by a physician who has not signed an 
Investigator agreement or not been trained in the use of the device, etc.), will be reported to 
PQ Bypass.  Investigators will also adhere to procedures for reporting study deviations to 
their EC and CA, where required, in accordance with their specific reporting policies and 
procedures. 
 
Regulations require that Investigators maintain accurate, complete and current records, 
including documents showing the dates of and reasons for each deviation from the 
protocol. 
 
 
 

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16.0 
REGULATORY CONSIDERATIONS 
16.1      
Maintaining Records 
The Sponsor will maintain copies of correspondence, data, shipment of devices, serious 
adverse device effects and other records related to the clinical trial. 
16.2      
Data Storage and Confidentiality 
Study information will be kept in HIPAA compliant files or in secure databases with access 
protected by password.  Neither subject names or other identifying information will be 
released from the site, nor will any identifying information be used in any published reports 
that are developed as a result of this study.  De identified copies of relevant source 
documents for each study visit with privacy protected copies of electronic image files for X
rays, DUS and CTA will be stored in secured files at PQ Bypass or at a validated data 
warehousing vendor.   
 16.3      
Site Record Retention Policy 
The Sponsor and clinical sites will maintain all records pertaining to this study for a period of 
seven years following the date on which the investigation is terminated or completed, or 
the date that the records are no longer required for purposes of supporting a regulatory 
submission. If the reviewing Ethics Committee or Competent Authority retention policy is 
longer than seven years, record retention will be mandated under those respective policies.  
Record retention dates will be provided to all concerned by the Sponsor. 
 
16.4      
Ethics Committee (EC) and Competent Authority (CA) Approval 
The trial will only be started in a center after written approval of the protocol and Patient 
Informed Consent has been obtained from the appropriate Ethics Committee.  Any 
amendment to the final protocol and informed consent should be submitted to the Ethics 
Committee.  
 
Regulatory approvals must be obtained prior to enrolment of the first patient. The Sponsor 
will arrange EC and CA approvals for the study. The Sponsor or its designated CRO 
(HealthLink) will require a copy of any EC and CA correspondence, as well as the final 
approval letter from the EC and CA, where applicable. 
No changes in the Clinical Investigation procedures will be effected without mutual 
agreement of the Principal Investigator and the Sponsor. The agreement of the changes 
must be documented by signing the corresponding Clinical Investigation Plan amendments. 
All changes require notification to the EC/IRB and the CA (when appropriate), or approval 
where requested by local regulations. Substantial changes may require approval from the 
EC/IRB and the CA prior to implementation. 
Substantial changes are changes which could: 
• have an effect on the safety of the clinical investigation participants, 

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• influence the interpretation of the documents on which the conduct of the clinical 
investigation is based, or 
• influence the other requirements assessed by the ethics committee. 
 
 

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17.0 
INVESTIGATOR RESPONSIBILITIES, RECORDS AND REPORTS 
17.1  
Investigator Responsibilities 
The Investigator is responsible for ensuring that this trial is conducted according to this 
protocol and that signed Informed Consent is obtained from each subject prior to his or her 
inclusion in this trial. 
 
It is the Investigator’s responsibility to ensure that all staff assisting with this trial have the 
appropriate qualifications and are fully instructed on the trial procedures and respect subject 
confidentiality, as specified in the Investigator Agreement with the Sponsor. 
 
The Investigator is responsible for ensuring that the conduct of the trial conforms to the EC 
and CA requirements and provides all necessary communication with the EC and CA 
including, but not limited to, annual trial reports and required adverse event notifications. 
 
17.2 
Investigator Records 
Case Report Forms 
 
The standardized Case Report Forms (CRFs) will be used to collect complete and accurate 
records of the clinical data from the trial according to the International Conference on 
Harmonization (ICH)/WHO Good Clinical Practice (GCP) standards. The Investigator is 
responsible for collecting and accurately recording the data generated for this trial. 
 
Screening Log 
 
Investigators will maintain a screening log that will record the date of informed consent, 
the date of screening, the enrollment status (enrolled/excluded) and the reason for 
exclusion for all screen failures. 
 
17.3 
Investigator Report 
The final clinical report will be prepared and provided to each Principal Investigator for 
submission to their respective IEC after conclusion of the trial. 
 
 

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18.0 
 PUBLICATIONS    
The PQ Bypass publications policy for this Study is as follows. Following the earliest of  a) 
publication of the multi center Study results, b) receipt of a notice from PQ Bypass stating 
that the multi center Study has been terminated or, c) twenty four (24) months after 
completion or termination of the Study at all Investigative sites, Investigators shall have the 
right to publish, in appropriate scientific journals or other professional publications, 
information and data collected or produced as a result of their participation in the Study, 
provided that drafts of the publications have been delivered to PQ Bypass for purposes of 
review and comment at least sixty (60) days prior to the first submission for publication or 
public release, to which Investigating Parties shall give due consideration.  PQ Bypass shall 
return comments to the Investigator within forty five (45) days receipt of the draft. In 
addition, the Investigator shall delay any proposed publication/presentation in the event PQ 
Bypass so requests to enable PQ Bypass to secure patent or other proprietary protection.  In 
all such publications, credit shall be given to PQ Bypass its sponsorship of the Study.  
Similarly, in publications by PQ Bypass regarding the Study, appropriate recognition will be 
given of the contribution made by the Institution and Principal Investigator, as applicable.  
PQ Bypass may use, refer to, and disseminate reprints of scientific, medical, and other 
published articles relating to the Study, including such reprints that disclose the name of 
Investigators and/or Institution.   
 
 
 
 

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19.0 
DEFINITIONS 
Acute Technical Success 
See Technical Success  
Adverse Device Effect 
An adverse event related to the use of an investigational medical device. This definition 
includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device. This definition also includes any event resulting from use error 
or from intentional misuse of the investigational medical device.  
Adverse Event (AE)  
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the investigational medical device or index procedure.  Adverse events are 
captured throughout the course of the study. 
Allergic Reaction to contrast, polyester, nickel compound of the device and/or anesthesia 
An overreaction of the body’s immune system to a component of an investigational device 
(e.g., nitinol metal, polyester, plastics), contrast agents and/or anesthesia medication given 
to the subject for completion of a study related procedure (e.g., MSCT, angiogram, 
investigational device), which requires medical intervention to treat the allergic reaction.  
Anesthesia Type 
Type of anesthesia administered.  Categorized as either general, local, or epidural/spinal.   
Anticipated Adverse Device Effect (AADE)  
 
An expected effect associated with endovascular treatment of the SFA and may occur during 
the procedure or during the course of the study. These anticipated effects have been 
previously identified in the risk analysis report. 
Blood Loss  
• 
Blood loss ≥ 1000 mL – Defined as any blood loss ≥ 1000 mL.  
• 
Estimated Procedural Blood Loss - Defined as the total estimated blood loss (mL) during 
the index procedure.  Includes blood loss resulting from adjunctive procedures 
performed during the index procedure.  
Contrast Volume 
 
Total volume of contrast (mL) administered during the index procedure.  Includes contrast 
administered for adjunctive procedures performed during the index procedure.  
Death 
Death is divided into two categories and will be reported anytime in a subject’s study 
participation. 
• Device or procedure related death - Death related to the Study Device or to any 
procedure (index or subsequent) intended to treat the target vessel.   

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• Non-device or procedure related death – Death NOT related to any procedure (index 
or subsequent) intended to treat the target vessel or death not related to the Study 
Device.   
Device Deficiency 
 
Inadequacy of the Study Device with respect to its identity, quality, durability, reliability, 
safety or performance. Device deficiencies include malfunctions, use errors, and inadequate 
labeling. 
Device Time 
 
Number of minutes from initial Study Device insertion to final Study Device removal.  It does 
not include time needed to perform adjunctive procedures.   
Explant 
 
Removal of the Study Device implant for any reason. 
Estimated Procedural Blood Loss 
 
See Blood Loss 
Fluoroscopy Time 
 
Total fluoroscopy time (minutes) used during the index procedure and includes time utilized 
for adjunctive procedures performed during the index procedure.  
Intensive Care Unit Time 
 
See post procedure ICU time 
Life Expectancy > 1 Year 
 
The duration of time the test subject is expected survive post procedure. Subjects must not 
have a concurrent medical condition that would cause expected survival to be less than one 
year. 
Longer-Term Technical Success (1-year) 
 
See Technical Success 
Major Adverse Event (MAE)  
 
Composite endpoint of the following:  defined as all death, TLR or any amputation of the 
index limb to 30 days (±7 days).  See individual events for detailed definitions.  
Myocardial Infarction (MI) 
10 
 
Typical chest pain and either a Q wave or non Q wave MI as described below.   
• Q-Wave Myocardial Infarction – Development of new, pathological Q waves in two or more 
contiguous leads V1 V3 or Q Wave ≥ 3 ms in width in leads I, II, aVL, AVF, V4, V5 or V6 and ≥ 
1 mm in depth on at least two serial ECGs.  
• Non-Q-Wave Myocardial Infarction – (1) Non procedural (pre procedural or > 30 days post
index procedure, endovascular or surgical intervention)  – CK MB elevation ≥ 2 times the 
                                                            
10 Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American 
College of Cardiology Committee for the redefinition of myocardial infarction. Eur Heart J. 2000 Sep;21(18):1502-13. 
Review.  

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upper limit of normal in the absence of new pathological Q waves, (2) post index procedure 
or endovascular re intervention (≤ 30 days) – CK MB elevation ≥ 3 times the upper limit of 
normal in the absence of new pathological Q waves, or (3) post Surgical intervention (< 30 
days) – CK MB elevation ≥ 5 times the upper limit of normal in the absence of new 
pathological Q waves. 
Post-Procedure ICU Time 
Number of hours a patient is in an intensive care unit prior to discharge or moving to a step 
down or standard care unit.   
Primary Assisted Patency 
Patency following endovascular re intervention at the target vessel site in case of 
symptomatic restenosis.  
Primary Patency 
No significant reduction of flow detectable by Duplex ultrasound (DUS) through the index 
lesion. Significant reduction of flow was determined as binary restenosis, defined as a peak 
systolic velocity ratio (PSVR) ≥2.5 as measured by DUS. 
Post-Procedure Length of Hospital Stay 
Number of days from the end of the procedure until the patient is discharged from the 
hospital. This does not include time spent in a skilled care facility.  
Procedure Time 
Number of minutes needed to perform the index procedure from time of initial vessel cut 
down time to time of final guidewire removal. Also referred to as skin to skin time. 
Renal Failure 
Need for dialysis or a laboratory finding of serum creatinine > 3.5 mg/dL.   
Respiratory Failure 
The need for mechanical ventilation beyond the first 24 hours post index procedure (and/or 
re intervention) or the need for re intubation or ventilator support after the first 24 hours 
(unless the subject was ventilator dependent pre procedure).   
Secondary intervention 
Any visit to the operating room or catheterization laboratory subsequent to the PQ Bypass 
Stent Graft implant procedure to treat an adverse event related to the disease, the index 
procedure or the study device.  
Secondary Patency 
Patency of the target lesion after treatment of a (re)occlusion of the index lesion. 
Serious Adverse Event (SAE)  
Any undesirable event occurring which led, could have led or might lead either directly or 
indirectly to the death or serious deterioration in the health of a subject, user or another 
person, regardless of whether the event was caused by the medical device. 
Stroke or Transient Ischemic Attack (TIA)  

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• 
Stroke - A new neurological deficit lasting more than 24 hours, or lasting 24 hours or 
less with a brain imaging study showing infarction.   
• 
TIA - A neurological deficit lasting less than 24 hours and, if an imaging study is 
performed, shows no evidence of infarction. These events may occur anytime throughout 
a subject’s study participation and may or may not require intervention. 
Stent Graft Occlusion 
Complete blockage of blood flow through the Stent Graft as determined by traditional 
imaging (e.g. DUS, CTA, MRA or Angiography).  
Stent Graft Placement Accuracy 
Estimated distance (mm) from the operator’s intended target as compared to the actual 
position placed as assessed via angiography during the index procedure.  
Target Lesion Revascularization (TLR) 
A re intervention of the index lesion site. 
Target Vessel Revascularization (TVR) 
Treatment of another lesion at the target vessel site but no the index lesion itself. 
Technical Success, Acute 
Successful delivery of PQ Bypass Stent Graft System to the identified area and successful 
removal of delivery system.   
Unanticipated Adverse Device Effect (UADE)  
An adverse device effect which by its nature, incidence, severity or outcome has not been 
identified in the risk analysis report. 
Vascular Access Type 
Method of entry into the vascular system.  Categorized as either surgical cut down or 
percutaneous.   
 
 
 
 
 

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20.0 
REFERENCES 
 
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2 National Institutes of Health. National Heart, Lung, and Blood Institute. Diseases and Conditions Index. What is 
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42 Bray PJ, Robson WJ and Bray AE. Percutaneous treatment of Long Superficial Femoral Artery Occlusive Disease: 
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43 Fischer M, Schwabe C, and Schulte KL. Value of the Hemobahn/Viabahn Endoprosthesis in the Treatment of Long 
Chronic Lesions of the Superficial Femoral Artery: 6 Years of Experience. J Endovasc Ther. 2006;13:281-290. 

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44 Saxon RR, Coffman JM, Gooding JM, et al. Long-term Patency and Clinical Outcome of the Viabahn Stent-Graft for 
Femoropopliteal Artery Obstructions. J Vasc Interv Radiol. 2007;18:1341-1350. 
45 Kedora J, Hohmann S, Garrett W, et al. Randomized comparison of percutaneous viabahan stent grafts vs 
prosthetic femoral-popliteal bypass in the treatment of superficial femoral arterial occlusive disease. J Vasc Surg. 
2007;45:10-16. 
46 Saxon RR, Chervu A, Jones PA, et al. Heparin-bonded, Expanded po ytetraf uoroethy ene- ned stent graft in the 
treatment of femoropopliteal artery disease: 1-year results of the VIPER Trial. J Vasc Interv Radiol. 2013;24:165-173. 
47 McQuade K, Gable D, Pearl G, et al. Four-year randomized prospective comparison of percutaneous ePTFE/Nitinol 
self-expanding stent graft versus prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery 
occlusive disease. J vasc Surg. 2010;52:584-91. 
48 Geraghty PJ, Mewissen MW, Jaff MR, et al. Three-year results of the VIBRANT trial of VIABAHN endoprosthesis vs 
bare Nitinol stent implantation for complex superficial femoral artery occlusive disease. J Vasc Surg. 2013:1-10. 
49 Abbott WM, Green RM, Matsumoto T, et al. Prosthetic above-knee femoropopliteal bypass grafting: Results of a 
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50 Johnson WC and Lee KK. A Comparative Evaluation of polytetrafluroethylene, umbilical vein and saphenous vein 
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Veterans Affairs Cooperative study. J Vasc Surg. 2000;32:268-77. 
51 Jackson MR, Belott TP, Dickason T, et al. The consequences of a failed femoropopliteal bypass grafting: 
comparison of saphenous vein and PTFE grafts. J Vasc Surg. 2000;32:498-505. 
52 Green RM, Abbott WM, Matsumoto T, et al. Prosthetic above-knee femoropopliteal bypass grafting: Five-year 
results of a randomized trial. J Vasc Surg. 2000;31:417-425. 
53 Solakovic E, Totic D and Solakovic S. Femoro-popliteal bypass above knee with saphenous vein vs Synthetic Graft. 
Bosn Jour Bas Med Sci. 2008;8(4):367-372. 
54 Lindholt JS, Gottschalksen B, Johannsen N, et al. The Scandinavian Propaten Trial – 1-Year Patency of PTFE 
Vascular Prostheses with Heparin-Bonded Luminal Surfaces Compared to Ordinary Pure PTFE Vascular Prostheses – 
A randomized controlled multi-centre trial. Eur J Vasc Endovasc Surg. 2011;41:668-673. 
55 Walluscheck KP, Bierkandt S, Brandt M, et al. Infrainguinal ePTFE vascular graft with bioactive surface heparin 
bonding. First clinical results. J Cardiovasc Surg. 2005;46(4):425-430. 
56 Johnston, PC, Vartanian, SM, Runge, SJ et al. Risk factors for clinical failure after stent graft treatment for 
femoropopliteal occlusive disease. J Vasv Surg. 2012;56:998-1007. 
57 http://www.nlm.nih.gov/medlineplus/ency/patientinstructions/000234.htm 
58 Rutherford RB, Padberg FT Jr, Comerota AJ, et al. Venous Severity Scoring: An Adjunct To Venous Outcome 
Assessment. J Vasc Surg. 2000;31(6):1307-1312. 
59 Villalta S, Bagatella P, Piccioli A, Lensing AWA, Prins MH, Prandoni P. (1994) Assessment of validity and 
reproducibility of a clinical scale for the postthrombotic syndrome. Haemostasis. 24:158a. 
60 Wiesinger B, Beregi JP, Olivia VL, et al. PTFE-Covered Self-Expanding Nitinol Stents for the Treatment of Severe 
Iliac and Femoral Artery Stenoses and Occlusions: Final Results From a Prospective Study. J Endovasc Ther. 
2005;12:240-246. 
61 Ahmadi R, Schillinger M, Maca T and Minar E. Femoropopliteal Arteries: Immediate and Long-term Results with a 
Dacron-covered Stent-Graft. Radiol. 2002;223(2):345-350. 
 
 
 
 
 

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May not be reproduced without written permission from PQ Bypass, Inc. 
 
STP 185-B6 Version Date: 02 May 2017                                                                                                   Page 82 of 85 
 
APPENDIX I: SAMPLE INFORMED CONSENT (ENGLISH VERSION) 
 
 
(Attached as separate document) 

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May not be reproduced without written permission from PQ Bypass, Inc. 
 
STP 185-B6 Version Date: 02 May 2017                                                                                                   Page 83 of 85 
 
 
APPENDIX II: INSTRUCTIONS FOR USE 
 
 
 
(Attached as separate documents) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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May not be reproduced without written permission from PQ Bypass, Inc. 
 
STP 185-B6 Version Date: 02 May 2017                                                                                                   Page 84 of 85 
 
 
APPENDIX III: SERIOUS ADVERSE EVENT REPORTING PROCEDURES 
 
The correct reporting procedures of SAEs to the BfArM can be found at the following website: 
http://www.bfarm.de/EN/MedicalDevices/clinTrials/ node.html 
The Ordinance on the Recording, Evaluation, and Prevention of Risks Associated with Medical Devices 
(Ordinance on Medical Devices Vigilance, "Medizinprodukte Sicherheitsplanverordnung", MPSV) of 
24 June 2002 (Federal Law Gazette (BGBl. I 2002), p. 2131 no. 40), was amended by Article 4 of the 
Ordinance on the Making Available of Medical Devices and amending the Regulations governing 
Medical Devices of 25 July 2014 (Federal Law Gazette (BGBl. I 2014), p. 1227, no. 35).  The following 
notification obligations for SAE reporting have applied since 29 July 2014: Investigators have to report 
all SAEs to the sponsor immediately. The sponsor of a clinical trial of a medical device that is 
conducted in Germany (and other countries) has to report SAEs to BfArM immediately or quarterly, 
depending on the following conditions. 
Condition for reporting to BfArM 
Country of 
occurence 
Timeline for 
reporting to 
BfArM 
Form 
A causal relationship between the SAE and the 
investigational medical device, a comparator 
device, diagnostic or therapeutic procedures 
performed as part of the clinical trial or other 
conditions of the trial conduct cannot be 
excluded 
Germany 
Immediately 
Single report 
 
German SAE Report Form 
 
All other 
countries where 
the clinical trial is 
performed 
Immediately 
Summary table 
 
MEDDEV 2.7/3 SAE report table 
 
All SAEs shall be documented 
using the same Excel file, in a 
cumulative manner, using the 
same Excel sheet. 
 
 
 
A causal relationship between the SAE and the 
investigational medical device, a comparator 
device, diagnostic or therapeutic procedures 
performed as part of the clinical trial or other 
conditions of the trial conduct can be excluded 
 
All 
Quarterly 
Summary table 
 
MEDDEV 2.7/3 SAE report table 
 
Please complete the MEDDEV 
Excel sheet as outlined above. 
 
 
 
All SAEs 
All 
Quarterly 
SAE summary evaluation 
 
Evaluation 
Annex 3.1 complication rate 
 

CONFIDENTIAL 
 
May not be reproduced without written permission from PQ Bypass, Inc. 
 
STP 185-B6 Version Date: 02 May 2017                                                                                                   Page 85 of 85 
 
 
 
 
Please observe our notes on 
completing the SAE summary 
evaluation 
 
Regardless of the criteria mentioned in the table, the sponsor must report all SAEs occurring in 
Germany to the competent authorities of other contractual states of the Agreement on the European 
Economic Area immediately if the clinical trial is also being performed in those countries. 
 
Important information for SAE summary evaluations 
The evaluation should be sent concurrently with the next SAE summary table (MEDDEV 2.7/3 SAE 
report table) and should be updated every 3 months. For further information please observe our 
notes on completing the SAE summary evaluation. 
 
Important information for completing the MEDDEV SAE Report Table 
The MEDDEV table is to be completed consecutively. Please always fill in the complete information 
for each case. New findings / updates to already reported events with relevance for the assessment 
may be added at any time. Please indicate your entry as "modified" in such cases. 
In the columns for dates please only enter pure dates in the "dd/mm/yyyy" format according to the 
MEDDEV specifications. Please avoid empty cells in cases where such information is available (e. g. 
in the column "Description of Event").