PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II)
Phase: NA
Conditions: Peripheral Arterial Disease
Sponsor: Endologix

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          STP115-F-Version Date 23-Feb-2017                                                                                                  Page 1 of 61 
 
 
 
 
 
 
 
 
 
PQ Bypass Systems for Femoropopliteal Bypass II 
 
PQB 4 FP II Protocol 
Signature Page 
 
 
CLINICAL PROTOCOL NUMBER  
STP 115 Rev F 
Issue Date: 23-Feb-17 
 
 
 
 
 
 
 
 
Approved by:  ______________________________________ 
 Ziad Rouag 
Vice-President, Clinical and Regulatory Affairs 
PQ Bypass, Inc. 
 
 
 
 
 
Date:   
 
 
 
 
The trial will be performed in accordance with the relevant parts of Title 21 CFR Parts 812, 
50,54, 56 and ISO 14155:2011:01; the ICH Guidelines for Good Clinical Practices (E6), the 
Declaration of Helsinki, and any regional and/or national regulations. 
 

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          STP115-F-Version Date 23-Feb-2017                                                                                                  Page 2 of 61 
 
 
Table of Contents 
1.0 
PRIMARY CONTACTS ................................................................................................................................ 6 
2.0 
INTRODUCTION ..................................................................................................................................... 13 
2.1 
Peripheral Artery Disease Background .............................................................................................. 13 
2.2 
Current Treatment Options ............................................................................................................... 13 
2.3 
Previous Clinical Experience .............................................................................................................. 17 
2.4 
Ongoing Clinical Experience (CE Mark Study) .................................................................................... 19 
3.0 
DEVICE / TECHNOLOGY DESCRIPTION ................................................................................................... 20 
3.1       Guidewire Delivery System (GWDS) – Percutaneous Anastomotic Device (PAD) .............................. 20 
3.2 
Guidewire Delivery System (GWDS) – Venous Locator (VL) .............................................................. 24 
3.3 
Stent Graft System (SGS) – Stent Graft (SG) ...................................................................................... 26 
3.4 
Stent Graft System (SGS) – Stent Graft Delivery System (SGDS) ....................................................... 27 
3.5 
Balloon Dilator (BD) ........................................................................................................................... 28 
4.0 
PROPOSED INTENDED USE .................................................................................................................... 29 
5.0 
STUDY DESIGN ....................................................................................................................................... 29 
5.1 
Study Design ...................................................................................................................................... 29 
5.2 
Study Endpoints ................................................................................................................................. 29 
5.3 
Study Duration ................................................................................................................................... 30 
5.4 
Number of Subjects and Sites ............................................................................................................ 30 
5.5 
Inclusion Criteria ................................................................................................................................ 30 
5.6 
Exclusion Criteria ............................................................................................................................... 31 
6.0 
SUBJECT ENROLLMENT INFORMATION ................................................................................................. 32 
6.1 
Written Informed Consent ................................................................................................................. 32 
6.2 
Enrollment ......................................................................................................................................... 32 
6.3 
Duration of Subject Participation ...................................................................................................... 32 
6.4 
Withdrawal of Subjects ...................................................................................................................... 32 
6.5 
Loss to Follow-Up .............................................................................................................................. 33 
6.6 
Subject Confidentiality ....................................................................................................................... 33 
7.0 
RISK-BENEFIT ASSESSMENT ................................................................................................................... 33 
7.1 
Risks ................................................................................................................................................... 33 
7.2 
Benefits .............................................................................................................................................. 34 
8.0 
STUDY PROCEDURE ............................................................................................................................... 34 
8.1 
Vascular Access and Guidewire Delivery ........................................................................................... 34 

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          STP115-F-Version Date 23-Feb-2017                                                                                                  Page 3 of 61 
 
8.2 
Stent Graft Placement ....................................................................................................................... 34 
8.3 
Follow-Up .......................................................................................................................................... 35 
9.0 
MATERIALS AND METHODS ................................................................................................................... 35 
9.1 
Initial Eligibility ................................................................................................................................... 35 
9.2 
Baseline Evaluation ............................................................................................................................ 35 
9.3 
Procedural Evaluation ........................................................................................................................ 35 
9.4 
Discharge Evaluation ......................................................................................................................... 36 
9.5 
Follow-Up Evaluation ......................................................................................................................... 36 
10.0 
INVESTIGATIONAL DEVICE DISTRIBUTION AND ACCOUNTABILITY ........................................................ 36 
10.1 
Device Accountability ........................................................................................................................ 36 
10.2 
Return of Devices............................................................................................................................... 36 
11.0 
ENDPOINTS AND STATISTICAL ANALYSIS PLAN...................................................................................... 37 
11.1 
Endpoints Analyses and Reporting of Results .................................................................................... 37 
11.2     Sample Size Justification .................................................................................................................... 38 
12.0 
ADVERSE EVENTS ................................................................................................................................... 42 
12.1     Adverse Event (AE) ............................................................................................................................. 43 
12.2 
Serious Adverse Event (SAE) .............................................................................................................. 44 
12.3 
Adverse Device Effect (UADE) ........................................................................................................... 44 
12.4 
Reporting of Adverse Events .............................................................................................................. 45 
12.5 
Reporting of Device Failures and Malfunctions ................................................................................. 46 
12.6 
Documentation, Evaluation and Notification of Serious Adverse Events .......................................... 46 
13.0 
MONITORING......................................................................................................................................... 47 
14.0 
STUDY ADMINISTRATION ...................................................................................................................... 47 
14.1     Source Documentation ...................................................................................................................... 47 
14.2 
Criteria for Terminating Study ........................................................................................................... 48 
14.3 
Criteria for Suspending/Terminating a Study Center ......................................................................... 48 
14.4 
Data Safety Monitoring Board (DSMB) .............................................................................................. 49 
15.0 
PROTOCOL DEVIATIONS ........................................................................................................................ 49 
16.0 
REGULATORY CONSIDERATIONS............................................................................................................ 50 
16.1     Maintaining Records .......................................................................................................................... 50 
16.2     Site Record Retention Policy .............................................................................................................. 50 
16.3     Ethics Committee (EC) and Competent Authority (CA) Approval ...................................................... 50 
17.0 
INVESTIGATOR RESPONSIBILITIES, RECORDS AND REPORTS ................................................................. 51 

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17.1 
Investigator Responsibilities .............................................................................................................. 51 
17.2 
Investigator Records .......................................................................................................................... 51 
17.3 
Investigator Report ............................................................................................................................ 51 
18.0 
PUBLICATIONS ....................................................................................................................................... 51 
19.0 
DEFINITIONS .......................................................................................................................................... 52 
20.0 
REFERENCES ........................................................................................................................................... 57 
 

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          STP115-F-Version Date 23-Feb-2017                                                                                                  Page 5 of 61 
 
 
LIST OF APPENDICES 
 
Appendix I: Sample Informed Consent (English Version) 
 
Appendix II: Guidewire Delivery System, Stent Graft System and Balloon Dilator Instructions for 
Use (English Version) 
 

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          STP115-F-Version Date 23-Feb-2017                                                                                                  Page 6 of 61 
 
 
 
1.0 
PRIMARY CONTACTS 
 
Sponsor and Data Management 
PQ Bypass, Inc. 
269 N. Mathilda Avenue 
Sunnyvale, CA 94085 
Phone: +1 (408) 940-3520 
Fax: +1 (408) 735-7420 
Ziad Rouag 
Vice- President Clinical and Regulatory Affairs 
PQ Bypass, Inc. 
Phone: +1-415-531-46472 
Email: zrouag@pqbypass.com 
Global Monitor / CRO 
Authorized EU Representative 
Claire van den Nieuwenhof 
Quality Manager 
 
HealthLink Europe BV 
HealthLink International Inc. 
De Tweeling 20-22 
5215 MC ‘S Hertogenbosch 
The Netherlands 
Phone General: +31-(0)13-5479300 
Fax: +31-(0)13-5479300 
E-mail: claire.vandennieuwenhof@healthlinkeurope.com 
Web:www.healthlinkeurope.com 
Legal Representative - Chile 
Bioscience Consulting Inc. 
Ruben Carnero 
Encomenderos 113 - 2do Piso Las 
Condes, Santiago, Chile Phone: +56. 
2.2570.3702 
Email: rcarnero@bioscienceweb.com 
Core Lab 
Vascular Ultrasound Core Lab 
 
Gail Hadley RN, RVT, FSVU, Technical Director 
One Bowdoin Sq. 10th floor | Boston | MA | 02114 
Business Office: 617-726-5552 
Mobile: 941-321-4523 | Fax: 617-726-1977 
gshadley@partners.org  
http://vascore.org 

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          STP115-F-Version Date 23-Feb-2017                                                                                                  Page 7 of 61 
 
 
 
PROTOCOL SUMMARY 
Title: 
PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II) 
Protocol Number 
STP 115 
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 Systemto  access,deliver 
guidewires and implant stent grafts for a percutaneous fem-pop bypass. 
Enrollment: 
Up to 100 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 
24-month enrollment period: 
• 
Initial enrollment: Q1, 2015 
• 
Last enrollment: Q1, 2017 
Study Duration 
60 months (24-month enrollment and 36-month follow-up) 
Primary Safety 
Endpoint: 
Major Adverse Events (MAE) at 1 month.   MAE is a composite endpoint 
defined as: 
• Death 
• Target Vessel revascularization (TVR) 
• Target limb amputation 
Primary 
Performance 
Endpoint: 
The rate of primary patency at 6 months 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), with no clinically-driven 
re-intervention within the stented segment.  The primary performance endpoint will be 
assessed by an independent Core Lab. 
Secondary Safety 
Endpoints: 
• Major Adverse Events (MAE) through follow-up. 
• Major adverse vascular event (MAVE) through follow-up 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. 
• Major Blood Loss defined as transfusion of >2 units packed red blood cells (PRBC)) 
through discharge. 
• The combined rate of death of target vessel revascularization (TVR), index limb 
amputation, and an increase in Rutherford-Becker Classification by 2 classes 
(comparing pre- to post-procedural assessments) through follow-up.  
• Deep Vein Thrombosis (DVT) on ipsilateral limb defined as a symptomatic blood clot 
(thrombus) in the targeted deep vein (e.g. posterior tibial) through follow-up. 
• Venous Clinical Severity Score (VCSS) and Villalta Scale through follow-up. 
• Venous Assessment (Miller Scale) through follow-up. 
• Stent fracture identified via X-ray through follow-up. Optional per standard practice. 
Not applicable if Radiological Safety Committee approval is required (e.g. BFS Germany) 
Secondary 
Performance 
Endpoints: 
• Technical Success defined as successful delivery of the investigational devices to the 
identified area and removal of delivery system.   
• Procedural Success defined as successful delivery of the investigational devices to the 

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identified area and removal of delivery system in the absence of in-hospital MAEs. 
• Clinical Success defined as Limb ischemia improvement by Rutherford-Becker 
(improvement in scale by ≥ 1) through follow-up. 
• Limb ischemia by Rutherford-Becker Classification through follow-up. 
• Primary Patency through follow-up. 
• Primary assisted patency 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 through follow-up. 
• Secondary patency 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 through follow-up. 
• Ankle-Brachial Index (ABI) through follow-up. 
• Target vessel revascularization (TVR) through follow-up. 
• Number of any type of index limb amputations through follow-up.   
• Number of vessel run-offs through follow-up. 
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.  
Inclusion Criteria: 
• Willing and able to provide informed consent. 
• Age 18 or older. 
• Willing to comply with the specified follow-up evaluation schedule. 
• Women of child bearing potential must have a negative pregnancy test within 7 days 
prior to the index procedure. 
• Severe claudication or rest pain or ischemic ulceration not exceeding ulcer of the digits 
of the foot (Rutherford Becker scale 3-5) with a resting ABI < 0.9.  Resting TBI is utilized 
only if unable to reliably assess ABI. TBI must be <0.7.   
• Subject is not morbidly obese (BMI<40). 
• Venous Clinical Severity Score <3. 
• Serum creatinine level < 2.0 mg/dL. 
• BUN ≤20 mg/dL. 
• 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 (TASC C and D) 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) 
• Reference vessel diameter (RVD) ≥ 5.0 mm and ≤ 6.7 mm, as measured via pre-
screening CTA/MRA using 3D RPR reconstruction.  
• Orifice and proximal SFA is patent (approximately 1 cm stump). 
• Patent popliteal artery 3 cm proximal to tibial plateau. 
• At least 1 patent tibial artery to the foot. 
• Patient has the ability to comply with the necessary follow-up examinations and tests 
in accordance with protocol. 
• Patent femoral vein ≥ 10 mm in diameter or duplicate femoral vein. 
• Subject has > 2 year life expectancy. 

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Exclusion Criteria: 
• Age greater than 90.  
• 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 7 days of the   
planned index procedure.  
• Known or suspected active infection at the time of the procedure.  
• Requires a coronary intervention 30 days or less prior to or 30 days post the treatment 
of the target lesion. 
• Thrombophlebitis, within the previous 30 days. 
• Thrombolysis of the target vessel within 72 hours prior to the index procedure, where 
complete resolution of the thrombus was not achieved. 
• Receiving dialysis or immunosuppressant therapy within the previous 30 days. 
• Stroke within the previous 90 days. 
• Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery. 
• Planned amputation of the target limb. 
• Previous bypass surgery on the target limb. 
• Participating in another clinical study for which follow-up may impact the current 
study. 
• Congestive heart failure, COPD (Stage IV, FEV1 <30% normal, or <50% normal with 
chronic respiratory failure present), metastatic malignancy, dementia, or other major 
co-morbidities that would prevent the post-interventional movement.  
• A condition that in the view of the investigator precludes participation in this study. 
Follow-Up: 
• Discharge 
• 1 month ± 7 days  
• 3 months ± 14 days 
• 6 months ± 30 days 
• 12 months ± 45 days 
• 18 months ± 45 days 
• 24 months ± 60 days 
• 30 months ± 60 days 
• 36 months ± 60 days 
 

 
        STP115-F-Version Date 23-Feb-2017                                                                                                  Page 10 of 61 
 
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Schedule of Assessments 
 
 
Activity 
Initial 
Eligibility 
Pre Procedural Baseline 
Screening 
Procedure 
Discharge 
Follow-up 
1M± 7D 
3M ± 14D 
6M ± 30D 
18M ± 45D 
24M ± 60D 
30M ± 60D 
36M ± 60D 
Follow-up 
12M ± 45D 
 
Informed Consent 
X 
Review of Inclusion/Exclusion Criteria 
X 
Pre-Procedural CTA /MRA 
X 
Pre-Procedural Venous Ultrasound 
X 
Medical History/Demographics 
X 
Ankle-Brachial Index 
X 
X 
X 
X 
Rutherford Assessments 
X 
X 
X 
X 
Serum Pregnancy Test 
X 
VCCS and Villalta Scale 
X 
X 
X 
X 
BUN and Creatinine 
X 
Final eligibility Angiogram/Venogram   
X 
Venous Ultrasound 
X 
X 
X 
Arterial Ultrasound 
X 
X 
X 
Stent Graft X-Ray * 
 
 
 
X 
Adverse Event Assessment 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
*Optional per standard practice. Not applicable if Radiological Safety Committee approval is required (e.g. BFS Germany).

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Patient Screening, Enrollment and Follow-Up 
 
 
 
 
 
1: Performed through CTA/MRA (artery) and Doppler ultrasound (vein) 
2: Investigators will access the target lesion and the corresponding ipsilateral vein using standard percutaneous 
techniques and devices. Patient eligibility will be confirmed prior to insertion of the study device, based on procedural 
angiogram and sheath placement.  

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Revision 
Letter 
Change Description 
A 
• 
Initial Release 
B 
• 
Increased sample size and number of sites 
• 
Updated inclusion exclusion criteria 
• 
Clarified schedule of assessment 
• 
Added reference to Core Lab 
• 
Added patient screening enrollment and follow-up flowchart 
• 
Added section for discharge evaluation. 
• 
Removed vital signs as a requirement after baseline evaluation 
• 
Clarified statistical plan 
C 
• 
Added Pre-Procedural Venous Ultrasound to Initial Eligibility 
• 
Updated signature pages 
• 
Clarified venous inclusion/exclusion criteria 
• 
Clarified statistical plan 
C1 
• 
Updated Per BFARM request 
C2 
• 
Updated Per BFARM request 
D 
• 
Updated per BfArM request 
D1 
• 
Updated per Austrian CA Request  
• 
Typographical corrections 
E 
• 
Increased enrollment to 100 patients  
• 
Updated statistical rational to account for surgical comparison 
• 
Updated primary safety endpoint to be in line with other SFA studies  
• 
Added additional secondary endpoints for analysis  
• 
Added Core Lab contact information 
• 
Clarified event reporting requirement, inclusive of Austria 
• 
Add all potential product adverse events per IFUs 
• 
Updated product images 
• 
Updates clinical outcome data to date 
• 
Added x-ray at 12-month follow-up 
• 
Added detailed listing of definitions  
E1 
• 
Minor typographical corrections, and other minor editorial changes/clarifications 
• 
Added Section 18 Publications per Latvian Regulations 
 
F 
• 
12-month X-ray for Stent Graft as Optional per standard practice. Not applicable if 
Radiological Safety Committee approval is required (e.g. BFS Germany) 
• 
Added Definition for Malignant Tumor 
• 
Added Appendix III: Justification for the Safety and Primary Performance Endpoints 
• 
Updated EU Rep 
• 
Updated Reporting SAE (Changed to 7 Days)  
• 
Updated Patient Follow up to include 30month FU Visit and 36 month FU Visit 
• 
Updated CoreLab Information 

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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 

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          STP115-F-Version Date 23-Feb-2017                                                                                               Page 14 of 61 
 
while reducing surgical and amputation rates from 1996-2006.12 (Figure 2-1). 
 
 
 
Figure 2-1: 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 2-2).34 

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          STP115-F-Version Date 23-Feb-2017                                                                                               Page 15 of 61 
 
TASC 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2-2: Primary Patency of SFA PTA and/or Stenting (letters indicate TASC 
lesion types [A-D] and prosthetic bypass surgery [P]) 
 
Despite lower patency in endovascular-treated TASC C/D groups, investigators are 
divided on whether to recommend surgery as the primary treatment for long- 
segment disease.25,27,28,32,33,35, 36 While some cite the superior primary patency of 
surgical grafts as the principle metric for recommendation, others cite the overall 
patient experience with surgical and endovascular means and conclude that 
endovascular methods should be attempted prior to subjecting a patient to the 
risks of open surgical repair. 
 
New evidence using “covered stents”/stent grafts may provide another useful 
variable to consider in treating TASC C/D lesions, or long-segment disease. Like 
bare metal stents, covered stents/stent grafts are preceded by PTA. Unlike 
traditional stents, however, these devices are covered with a synthetic material; 
most commonly polytetrafluoroethylene (PTFE) or Dacron (knitted polyester), the 
same materials used for prosthetic surgical bypass. Much like investigators who 
theorized that a sub-intimal approach to long-segment angioplasty would lead to 
better outcomes by precluding the existing atheroma from the new lumen, covered 
stents eliminate the previously atherosclerotic vessel from direct communication 
with the blood which may eliminate some of the limitations experienced by other 
endovascular therapies in longer lesions.27, 37 Some of the earliest work reported in 
the literature began in the mid-1990’s and found 79% patency at 12 months in 
lesions averaging 13.1cm in length (5-40cm).37 These initial results compare very 
favorably to stents and PTA, both of which fail to reach 50% patency at 12 months 
in lesions longer than 10 cm. Since that time, a number of additional studies using 
stent grafts have been conducted supporting their effectiveness in long lesions; 
average 12- month patency is 73% in lesions between 10-15 cm and 71% in lesions 
between 15- 
26 cm.26, 38,39, 40, 41, 42, 43, 44, 45, 46 In terms of TASC Classification, stent grafts continue 
to demonstrate excellent patency in more complex lesions (Figure 2-3).38 

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          STP115-F-Version Date 23-Feb-2017                                                                                               Page 16 of 61 
 
 
 
 
 
TASC A 
TASC C 
 
 
TASC B 
 
 
 
 
TASC D 
 
 
 
 
 
 
 
Figure 2-3: Primary Patency of SFA Stent Grafting 
 
While TASC D patients continue to have poor prognosis compared to TASC A-C, the 
patency rates for all lesion types are improved relative to stenting and PTA. These 
apparent improvements in patency have also been confirmed in prospective 
comparisons. One study identified 12-month patency of 75% and 28% for stent 
grafts and PTA, respectively, in the treatment of long-segment lesions (>15 cm).26 
Another study found an equally dramatic difference with 12-month patency of 87% 
at 2 years in the stent graft group versus 23% with PTA in relatively short lesions 
(6.9 cm).22     The leading stent graft on the market obtained FDA approval 
demonstrating a more modest difference in 12-month primary patency (stent grafts 
– 62%, PTA – 40%).21 In the same study, the difference was more striking in long 
lesions (>13 cm) where the stent graft group maintained patency at a rate of 
54% where the PTA group fell to 17% at 12 months. Stent grafts also fare well when 
compared to synthetic bypass grafting in femoropopliteal occlusive disease. A 
recently published four-year randomized study found no difference between the 
stent graft and synthetic surgical bypass groups at any follow-up period from 1 to 
4 years in patients with an average lesion length of 25 +/- 15 cm (SD) and TASC 
scores distributed equally among A through D.47 
 
While these findings are very promising, reports do exist that suggest stent grafts 
may not have an advantage over more conventional therapy. In a randomized 
evaluation of stent-grafts and bare metal stents in long-segment femoropopliteal 
disease (18-19 cm), no difference was identified between the two treatment groups 
over three years; primary patency at 3 years was 24.2% and 25.9% for the stent 
graft and bare metal stents, respectively.48 While this report highlights the 
difficulty in treating long lesions with either endovascular method, the collective 
evidence supports using stent grafts in long lesions over traditional PTA and 
stenting. 
 
The PQ Bypass approach to treating long-segment disease builds on the concept of 
stent grafting by implementing the use of a stent graft in a manner similar to 
surgical bypass. Where standard stent grafts are placed across lesions intra- 
arterially, the PQ Bypass stent grafts exit the artery proximal to the lesion and re- 

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          STP115-F-Version Date 23-Feb-2017                                                                                               Page 17 of 61 
 
enter the arterial lumen at the distal reconstitution site, leaving only a small portion 
 
of a stented graft inside of the native artery and bypassing the heavily diseased 
area. Using the same synthetic materials to surgically bypass lesions yields an 
average 12-month primary patency of 80%.39, 45,49, 50, 51, 52,53, 54, 55 
 
The PQ Bypass approach to treating long-segment disease also takes advantage of 
the reduced risk associated with endovascular repair compared with surgery. In 
reviewing the literature on traditional endovascular techniques (e.g., PTA, stents 
and stent grafts), very little information on co-morbidities can be identified. The 
majority of the safety concerns cited are related to the need for re-intervention. In 
fact, one recent study looking at the safety of stent graft use at one study center 
looked specifically for the use of thrombolysis (for occlusions) and the need for 
amputation and bypass surgery as their primary endpoint.56 Restenosis or 
thrombosis of the target lesion/stent/stent graft requires the patient be exposed 
to another interventional procedure which carries some degree of safety concerns. 
These include, but are not limited to: access site hemorrhage or hematoma, access 
site pain, acute vessel closure, embolism, infection, and renal insufficiency/failure 
due to excessive contrast load. 
 
Patients undergoing endovascular repair are often discharged from the hospital the 
next day whereas surgically treated patients may stay in the hospital for up to 7 
days. Endovascularly treated patients can often go back to normal activities within 
the first week following the procedure. Surgically treated patients can take 6 weeks 
or longer to fully recover56,57. These extended recovery times combined with 
increasingly positive patency findings, are the principle reasons behind the 
previously cited decline in surgery and rise of endovascular repairs in recent years. 
 
PQ Bypass seeks to place stent grafts in bypass conduit via a percutaneous method 
to evaluate the bypass concept as it compares to standard stent graft placement. 
 
2.3 
Previous Clinical Experience 
 
Over the past decade, the founders of PQ Bypass have pioneered the percutaneous 
femoro-popliteal bypass approach using off-the-shelf devices. Dr. James Joye was 
referred patients with long-segment femoropopliteal disease that were destined for 
either bypass surgery or below the knee amputation. A retrospective review of 
patients treated by Dr. Joye was conducted in order to collect data and assess the 
safety and performance of this novel technique. This study was called “A Review of 
Patients Undergoing Percutaneous Femoropopliteal Bypass for the Treatment of 
Superficial Femoral Artery Occlusive Disease”. This study is henceforth referred to 
as the El Camino Hospital (ECH) Study. The following are the results of that 
retrospective review. From 2003 to 2012, Dr. Joye treated 25 limbs in 21 patients 
for whom data are currently available. Two patients in this group experienced graft 
failures due to extraneous circumstances. One patient was involved in an 
automobile accident that required a tourniquet on his bypassed limb, leading to an 
occlusion, and the other patient had upstream iliac disease from which an embolus 
originated and caused a downstream graft thrombosis. With these two exclusions, 
there are 23 limbs from 19 patients available for review. Average lesion length was 
32 cm and all but 3 were TASC D lesions (19/22) involving the SFA and popliteal 

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          STP115-F-Version Date 23-Feb-2017                                                                                               Page 18 of 61 
 
arteries. Using a commercially available re-entry tool and stent graft, Dr. Joye 
successfully bypassed each of these patient’s lesions percutaneously. At 6 and 12- 
months, 91% and 82% of the bypass grafts, respectively, remained widely patent 
without the need for re-intervention (Figure 2-4). 
 
 
 
Figure 2-4 – Primary Patency 
 
These results compare favorably with competitive endovascular procedures, all of 
which fail to reach 50% primary patency in this patient cohort. More importantly, 
none of the 23 limbs has been amputated a 100% limb survival rate. 
 
In addition to excellent patency outcomes, as previously stated, all treated limbs 
survived and no venous sequelae have been identified. To further evaluate the use 
of the femoral vein as a conduit for the bypass, all patients that were available for 
follow-up were contacted, and a prospective evaluation of their lower extremity 
veins was conducted. Recently, 16 subjects (20 limbs) treated between 2003 and 
2012 have returned for a duplex ultrasound of each treated limb. There were no 
venous sequelae identified in this patient cohort; all patients exhibited normal reflux 
and no evidence of deep vein thrombosis, thrombophlebitis or chronic edema. Only 
one vein out of the 20 limbs was occluded; however, the patient was not 
experiencing any venous related health concerns as a result. The patient underwent 
the percutaneous femoro-popliteal bypass in August 2011 and had a venous and 
arterial ultrasound performed in July 2013. This patient’s arterial bypass graft 
remains widely patent without the need for re-intervention. 
 
While this initial report is based on “off-the-shelf” devices that were not originally 
designed for this procedure the success rate proves the concept of the percutaneous 
bypass approach and supports the safety of using the femoral vein as a conduit for 
the bypass. PQ Bypass has designed and developed a kit of devices specific for this 
percutaneous procedure and is in the process of generating additional evidence 
supporting this novel therapeutic approach through the current CE Mark study.  
 
 

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          STP115-F-Version Date 23-Feb-2017                                                                                               Page 19 of 61 
 
 
 
2.4 
Ongoing Clinical Experience (CE Mark Study) 
The ongoing 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. Enrollment and follow-up is ongoing. Table 2 below is a summary 
of the protocol. As noted in the inclusion exclusion criteria the population being 
treated involves TASC C/D long lesions (avg. = 28 cm) including CTOs. The results 
from the CE Mark study, showing high patency and low morbidity in TASC D lesions, 
may serve to support the safety profile of the Stent Graft. Core lab adjudicated 
outcomes through 6 months for 30 subjects are provided in Figure 2-5 and Figure 2-
6 below.  With an average lesion length of 28 cm and a primary patency of 90% at 6 
months, results are encouraging. 
 
 
Figure 2-5 –Lesion Characteristics 

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          STP115-F-Version Date 23-Feb-2017                                                                                               Page 20 of 61 
 
 
 
 
Figure 2-6 –Core Lab Assessed Outcomes to Date 
 
3.0 
DEVICE / TECHNOLOGY DESCRIPTION 
 
PQ Bypass designs and manufactures the PQ Bypass Guidewire Delivery System (GWDS) 
and the PQ Bypass Stent Graft System (SGS) and purchases the PQ Bypass Balloon Dilator 
(BD) from an Original Equipment Manufacturer (OEM). The GWDS is comprised of the 
Percutaneous Anastomotic Device (PAD) and the Venous Locator (VL) and is intended to 
support the delivery of guidewires in the peripheral vasculature. The SGS is comprised of 
a Stent Graft and a Stent Graft Delivery System and is intended to place stent grafts in the 
peripheral vasculature to improve blood flow. The BD is a standard percutaneous 
transluminal angioplasty (PTA) balloon used to dilate arterio-venous anastomoses. When 
used together, the GWDS, SGS and BD allow for a percutaneous bypass procedure in the 
peripheral vasculature. 
 
3.1       Guidewire Delivery System (GWDS) – Percutaneous Anastomotic Device (PAD) 
 
The PAD (Figure 3-1) is a spring-loaded dual guidewire delivery tool that utilizes a 
0.025” Nitinol Needle with a 15 mm throw that exits approximately 45° to the PAD 
shaft. The PAD is an 8Fr compatible device with 135 cm working length with dual 
0.014” guidewire (GW) ports; an Rx GW Port and a Needle GW Port. The Rx GW 
Port is a back-loaded, rapid-exchange (Rx) design used for initial device placement. 
The Needle GW Port is the central lumen that exits through the Needle and is used 
to deliver guidewires to the desired location. The PAD also incorporates an intra- 
luminal Stabilizer and a Platinum-Iridium Marker Band used to support and direct 
needle deployment, respectively. The PAD features are controlled using the Outer 
Handle and the Button on the PAD Handle. 

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          STP115-F-Version Date 23-Feb-2017                                                                                               Page 21 of 61 
 
 
Figure 3-1: Percutaneous Anastomotic Device (PAD) 
 
The Outer Handle controls spring loading, Stabilizer deployment and Needle 
activation. The user rotates the Outer Handle counter-clockwise and moves it 
proximal to distal to load the spring, deploy the Stabilizer and activate the Needle 
for deployment in a single motion. The PAD Shaft is keyed to ensure that the 
Needle cannot be deployed without first loading the spring and deploying the 
Stabilizer. Subsequent depression of the Button deploys the Needle in the direction 
indicated by the Marker Band. 
 
The Distal Tip of the PAD is inserted into the Distal Tip of the Venous Locator to 
dock the devices in the vein when creating the distal anastomosis. 
 
Stabilizer 
 
The Stabilizer is intended to stabilize the PAD during Needle deployment in the 
intra-luminal space. The Stabilizer is made of laser-cut Polyimide tubing laminated 
on the outer PAD Shaft. The Stabilizer is 8 mm in diameter in a deployed state 
(Figure 3-2). 
 
Un-deployed 
Deployed 
 
 
 
 
 
 
 
Needle 
Figure 3-2: Stabilizer 
 
The Needle utilizes a lancet-point to access discrete regions of the peripheral 
vasculature and allow guidewire delivery. The Needle is a 0.014” guidewire 
compatible nickel-titanium (NiTi) tube that is heat-set with a 15 mm throw. The 
Needle’s lancet-point design enables penetration of calcified vessels (Figure 3-3). 
 
 
 
Button 
Outer 
Handle 
Needle 
GW Port 
Inner Handle 
Shaft 
Stabilizer 
Needle 
Marker 
Band 
Rx GW 
Port 
Tip 

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Marker Band 
 
Figure 3-3: Needle Tip 
 
The PAD uses a proprietary radiopaque Crown Marker Band System to orient the 
device prior to Needle deployment under fluoroscopy. The Crown Marker Band 
System (Crown System) indicates Needle direction and allows approximate 
adjustments in the Anterior/Posterior plane (Figure 3-4, Figure 3-5 and Figure 3-6). 

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          STP115-F-Version Date 23-Feb-2017                                                                                               Page 23 of 61 
 
 
 
 
Figure 3-4: PAD Distal Tip Assembly 
 
 
 
 
Needle Right 
 
 
 
Needle Anterior 
 
 
 
Needle Posterior 
 
 
 
 
 
Needle Left 
 
 
 
Figure 3-5: Crown Marker Band System Needle Direction (directions are noted from the 
perspective of the device in a supine patient) 
 
 
 
 
5° 
10° 
15° 
 
* 
* 
* 
* 
 
Figure 3-6: Crown Marker Band System: Direction Adjustment (Needle Direction indicated by *) 

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          STP115-F-Version Date 23-Feb-2017                                                                                               Page 24 of 61 
 
 
3.2 
Guidewire Delivery System (GWDS) – Venous Locator (VL) 
 
The VL (Figure 3-7) is an over-the-wire endovascular snare that utilizes dual, 
radiopaque NiTi cages to provide scaffold support to the femoral vein and to snare 
guidewires. The VL is 85 cm in length and is compatible with 7Fr sheaths and 0.014” 
guidewires. The dual NiTi cages deploy to a maximum of 11 mm at the apex and 
can be secured at a fixed diameter at any point during expansion (Figure 3-8). 
 
 
Figure 3-7: Venous Locator (VL) 
 
 
 
 
Proximal Handle 
 
 
Cage Hypotube 
Distal Handle 
 
Inner Sheath 
 
Outer Sheath 
 
NiTi Cages 
 
Guidewire Port 
 
 
 
 
 
 
 
 
Proximal 
RHV 
 
Distal RHV 
Inner 
Sheath Tip 

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Figure 3-8: VL Cages Deployed 
 
The VL is controlled using two rotating hemostasis valves (RHVs) and two 
handles. The Proximal Handle is connected to the Cage Hypotube which 
controls the retraction/deployment of the NiTi Cages. The Distal Handle allows 
the user to apply tension while manipulating the Proximal Handle. The Cage 
Hypotube runs through the Proximal RHV which is loosened to deploy/retract 
the NiTi Cages or tightened to lock the NiTi Cages in the desired position. The 
Distal RHV is connected to the Outer Shaft which slides over the retracted NiTi 
Cages for access, snaring and removal. The Inner Sheath defines the length of 
the device and provides a lumen through which the Cage Hypotube moves to 
allow NiTi Cage manipulation. The Inner Sheath Tip enables docking to the PAD 
when creating the distal anastomosis. The VL also has radiopaque markers at 
the proximal and distal ends of the NiTi Cages, between the NiTi Cages and at 
the distal tip to aide visualization during placement and deployment. The NiTi 
Cages are also radiopaque to enable visualization during use. 
 
VL and PAD Docking 
The Inner Sheath Tip of the VL (Figure 3-9) is shaped like a cone to allow docking 
to the PAD when creating the distal anastomosis. The user advances the PAD 
and VL on the same 0.014” guidewire to dock the PAD to the VL when creating 
a vein-to- artery anastomosis. Just as the Stabilizer is used to stabilize the PAD 
during Needle deployment in the intra-arterial space, docking the PAD to the VL 
stabilizes the PAD during Needle deployment in the intra-venous space. 
 
Guidewire Lumen 
 
 
 
 
 
PAD Docking Zone 
 
 
 
 
Figure 3-9: Inner Sheath Tip 
 
 
 
 
 
 
 

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3.3 
Stent Graft System (SGS) – Stent Graft (SG) 
 
The PQ Bypass Stent Graft (SG) is a flexible, self-expanding composite structure 
made of a NiTi-wire frame encapsulated in an expanded Polytetrafluorethylene 
(ePTFE) film. 
 
The SG comes in a terminally sterile package pre-loaded on the Stent Graft Delivery 
System (SGDS). The SG uses a standard, crowned wire frame design that exhibits 
approximately twice the radial strength of commercially available stent grafts and 
comparable bending capability without kinking (Figure 3-10). The enhanced radial 
force helps maintain an open lumen through the proximal and distal anastomotic 
sites. The SG can be used either for standard intra-arterial placement or for a 
percutaneous bypass procedure. 
 
 
18mm 
 
 
Figure 3-10: PQ Bypass Stent Graft encapsulated in ePTFE 
 
 

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NiTi Frame: 
The SG frame is a nitinol (NiTi) wire formed structure. It is made from a single 
0.008” diameter NiTi wire which is shape-set and electropolished (Figure 3-11). The 
NiTi frame is a helically wrapped 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 3-11: NiTi Wire Frame (pictured on a process mandrel) 
 
Stent Graft Cover: 
 
The NiTi wire frame is completely encapsulated by the ePTFE material. The ePTFE 
material is made from the same base material and manufacturing processes as the 
ePTFE used in AAA stent grafts. It has high tensile strength and low strain and 
maintains excellent abrasion resistance. Due to the frame design, the cover can be 
applied to both the inner and outer lumen while maintaining flexibility and 
compressibility. The inner and outer layers of the Cover are thermally laminated 
together. 
 
3.4 
Stent Graft System (SGS) – Stent Graft Delivery System (SGDS) 
 
The Stent Graft Delivery System (SGDS) is an 8Fr system. It is 0.035” guidewire 
compatible and has a 135 cm working length.  The handle of the delivery system 
consists of an internal pulley mechanism activated through turning an external 
knob.  The handle also features the fluid flush insertion point for the inner lumen. 
The SGDS is a familiar design which uses an outer sheath to maintain the SG in a 
compressed state. Once at the target site, the user can slide the outer sheath 
proximally by turning the knob to expose the SG which is self-expanding. The SGDS 
has radiopaque markers on both the proximal and distal ends of the SG landing 
zone (area where SG is located), as well as a marker band on the outer sheath to 
allow visualization of the sheath during deployment.   The SGDS is shown below 
(Figure 3-12). 

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Figure 3-12: Stent Graft Delivery System 
 
The outer sheath of the SGDS consists of PTFE liner, braid, and pebax layers 
laminated together. The proximal area of the outer sheath (area behind the SG) 
consists of a second layer of extrusion to reduce stretching during SG deployment. 
 
The inner shaft of the SGDS consists of a guidewire lumen, which has a section 
where the SG is compressed to minimize movement during deployment. Proximal 
to this section, the inner shaft has a proximal stop bushing, followed by a solid 
wound coil, which runs the entire length of the inner shaft to the handle. The 
proximal stop bushing reacts to the compressive load on the inner shaft created 
during stent graft deployment. The coil reacts to this same load, but transfers it to 
the handle section, which is rigid. 
 
The outermost sheath of the SGDS, or the tri-axial layer, isolates the outer shaft 
from friction induced by the valve of the introducer sheath, the vessel walls, and 
other sources of interference.  This allows the outer shaft to be retracted with a 
lower deployment force, and for the SG to be deployed more accurately. 
 
3.5 
Balloon Dilator (BD) 
 
The BD is a 4 mm by 40 mm PTA balloon used to dilate arterio-venous anastomoses 
during a percutaneous bypass procedure. The BD is 4Fr compatible with an OTW 
0.014” guidewire port. PQ Bypass purchases the BD as a finished product from 
ClearStream Technologies, who designed and manufactures the BD. ClearStream 
Technologies commercially markets the BD as the Bantam Alpha Catheter which 
received its initial CE Mark in 2008 as a PTA balloon (0344). PQ bypass does not 
modify the device upon receipt except to label the product as the BD and provide 
instructions for how to utilize the product during a percutaneous bypass procedure. 
 
 
 
 
 
 
 
 
 

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          STP115-F-Version Date 23-Feb-2017                                                                                               Page 29 of 61 
 
 
4.0 
PROPOSED INTENDED USE 
 
The PQ Bypass Guidewire Delivery System is intended to support the delivery of guidewires 
in the peripheral vasculature. 
 
The PQ Bypass Stent Graft System is intended to improve blood flow in patients with 
peripheral artery disease. 
 
The PQ Bypass Balloon dilator is intended to dilate arterio-venous anastomoses in the 
peripheral vasculature. 
 
 
5.0 
STUDY DESIGN 
 
5.1 
Study Design 
 
Prospective, multi-center, non-randomized study evaluating the safety and 
performance of the PQ Bypass Systems to access, deliver guidewires and implant 
stent grafts for a percutaneous femoropopliteal (fem-pop) bypass. 
 
5.2 
Study Endpoints 
 
Primary Safety Endpoint: 
Major Adverse Clinical Events (MAE) at 1 month, defined as death, target vessel 
revascularization (TVR), target limb amputation. 
 
Primary Performance Endpoint: 
Primary Patency at 6 month, 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), with no 
clinically-driven re-intervention within the stented segment. 
 
Secondary Safety Endpoints:   
• Major Adverse Events (MAE) through follow-up. 
• Major adverse vascular event (MAVE) through follow-up 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. 
• Major Blood Loss defined as transfusion of >2 units packed red blood cells (PRBC)) 
through discharge. 
• The combined rate of death of target vessel revascularization (TVR), index limb 
amputation, and an increase in Rutherford-Becker Classification by 2 classes 
(comparing pre- to post-procedural assessments) through follow-up.  
• Deep Vein Thrombosis (DVT) on ipsilateral limb defined as a symptomatic blood 
clot (thrombus) in the targeted deep vein (e.g. posterior tibial) through follow-
up. 
• VCSS and Villalta Scale through follow-up. 
• Venous Assessment (Miller Scale) through follow-up. 

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• Stent fracture identified via X-ray through follow-up. (Optional per standard 
practice. Not applicable if radiological Safety Committee approval is required e.g. 
BFS Germany). 
 
Secondary Performance Endpoints: 
• Technical Success defined as successful delivery of the investigational devices to 
the identified area and removal of delivery system.   
• Procedural Success defined as successful delivery of the investigational devices 
to the identified area and removal of delivery system in the absence of in-
hospital MAEs. 
• Clinical Success defined as Limb ischemia improvement by Rutherford-Becker 
(improvement in scale by ≥ 1) through follow-up. 
• Limb ischemia by Rutherford-Becker Classification through follow-up. 
• Primary Patency through follow-up. 
• Primary assisted patency 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 through follow-up. 
• Secondary patency 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 through follow-up. 
• Ankle-Brachial Index (ABI) through follow-up. 
• Target vessel revascularization (TVR) through follow-up. 
• Number of any type of index limb amputations through follow-up.   
• Number of vessel run-offs through follow-up. 
 
5.3 
Study Duration 
 
This study is expected to commence enrollment in the fourth quarter of 2014. 
Enrollment of all subjects is expected to be completed in the first quarter of 2017. 
Clinical follow-up will occur at 3 months (±14 days), 6 months (±30 days), 12 months 
(±45 days), 18 months (±45 days) 24 months (±60 days), 30 months (±60 days), 36 
months (±60 days) following the procedure.  
 
5.4 
Number of Subjects and Sites 
 
 Up to 60 subjects meeting all inclusion criteria and absent all exclusion criteria, 
and who are willing to sign informed consent will be enrolled in the first phase of 
the study including: 
• Up to 30 subjects in Germany 
Up to 100 subjects will be enrolled in the second phase of the study (additional 40 
subjects) including:  
• Up to 30 subjects in Germany 
 
5.5 
Inclusion Criteria 
 
Subjects must meet all of the following criteria to be eligible for enrollment in this 
trial: 
 
• Age 18 or older. 

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• Willing to comply with the specified follow-up evaluation schedule. 
• Women of child bearing potential must have a negative pregnancy test within 
7 days prior to the index procedure. 
• Severe claudication or rest pain or ischemic ulceration not exceeding ulcer of 
the digits of the foot (Rutherford Becker scale 3-5) with a resting ABI < 0.9.  
Resting TBI is utilized only if unable to reliably assess ABI. TBI must be <0.7. 
• Subject is not morbidly obese (BMI<40). 
• Venous Clinical Severity Score <3. 
• Serum creatinine level < 2.0 mg/dL. 
• BUN < 20 mg/dL. 
• 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 (TASC C and D) 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) 
• Reference vessel diameter (RVD) ≥ 5.0 mm and ≤ 6.7 mm, as measured via 
pre-screening CTA/MRA using 3D RPR reconstruction.  
• Orifice and proximal 1 cm of SFA is patent (approximately 1 cm stump). 
• Patent popliteal artery 3 cm proximal to tibial plateau. 
• At least 1 patent tibial artery to the foot. 
• Patient has the ability to comply with the necessary follow-up examinations 
and tests in accordance with protocol. 
• Patent femoral vein ≥ 10 mm in diameter or duplicate femoral vein. 
• Subject has > 2 year life expectancy. 
 
5.6 
Exclusion Criteria 
 
Subjects will be excluded from this trial if any of the following criteria are met: 
 
• Age greater than 90.  
• 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 7 days 
of the   planned index procedure.  
• Known or suspected active infection at the time of the procedure. 
• Requires a coronary intervention 30 days or less prior to or 30 days post the 
treatment of the target lesion. 

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• Thrombophlebitis, within the previous 30 days. 
• Thrombolysis of the target vessel within 72 hours prior to the index 
procedure, where complete resolution of the thrombus was not achieved. 
• Receiving dialysis or immunosuppressant therapy within the previous 30 days. 
• Stroke within the previous 90 days. 
• Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery. 
• Planned amputation of the target limb. 
• Previous bypass surgery on the target limb. 
• Participating in another clinical study for which follow-up is currently on going 
which may impact the current study. 
• Congestive heart failure, COPD (Stage IV, FEV1 <30% normal, or <50% normal 
with chronic respiratory failure present), metastatic malignancy, dementia, or 
other major co-morbidities that would prevent the post-interventional 
movement.  
• A condition that in the view of the investigator precludes participation in this 
study. 
 
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 
and the corresponding ipsilateral vein using standard percutaneous techniques and 
devices. Patient eligibility will be confirmed prior to insertion of the study device, 
based on procedural angiogram and sheath placement. 
 
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. 
 

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6.5 
Loss 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 or their participation in this trial will be 
considered confidential. Only authorized PQ Bypass personnel and designated 
consultants and regulatory agencies will 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 from all 
patient identifiers. 
 
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. The risks stated 
below concern each system manufactured by PQ Bypass and their use in the PQ 
Bypass procedure. 
 
Possible risks related to the PQ Bypass Guidewire Delivery System include, but are 
not limited to, the following: vessel dissection, perforation or wall trauma, 
embolism, infection, bruising or hemorrhage at the procedural access site, deep 
vein thrombosis, bleeding or infection. 
 
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, venous flow disruption (including deep vein thrombosis, edema or 
phlebitis), arteriovenous fistula formation, bleeding infection or side branch 
occlusion. 
 
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 for life and Plavix 

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(clopidogrel) or Ticlid (ticlopidine) for length of follow-up. 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. 
 
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, heparin) 
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. 
 
7.2 
Benefits 
 
Patients included in this study have lesions that are challenging to treat with 
conventional endovascular means. Based on previous treatments using 
commercially available devices and PQ Bypass’s bench and animal testing, it is 
expected that the participants in this study will have their lesions successfully 
treated without the need for surgery. Bypassing lesions with the PQ Bypass Systems 
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. 
 
8.0 
STUDY PROCEDURE 
 
8.1 
Vascular Access and Guidewire Delivery 
 
Investigators will access the target lesion and the corresponding ipsilateral vein 
using standard percutaneous techniques and devices. Patient eligibility will be 
confirmed prior to insertion of the study device, based on procedural imaging and 
sheath placement.  
 
After eligibility confirmation, the Venous Locator (VL), Percutaneous Anastomotic 
Device (PAD) and Balloon Dilator (BD) will be used to deliver a guidewire from the 
arterial segment proximal to the target lesion, through the femoral vein and back 
into the reconstituted artery distal to the target lesion. This procedure is described 
in detail in the Guidewire Delivery System and Balloon Dilator IFUs (Appendix II). 
The number of deployment attempts for guidewire placement access at each 
anastomosis will be recorded. 
 
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). SGs are then deployed in 
series, starting distally, until the bypass is complete. 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. 
 

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8.3 
Follow-Up 
 
Subjects will return to the study center at 1 month (±7 days), 3 months (±14 days), 
6 months (±30 days), 12 months (±45 days), 18 months (±45 days) 24 months (±60 
days),30months (±60 days) and 36 months (±60 days) following the procedure for a 
follow-up evaluation. The subject will undergo lower-extremity arterial and venous 
duplex ultrasounds, venous health questionnaires and examined for any post-
procedural complications or adverse events.  
 
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 will consist of the following: 
 
• Pre-procedural CTA or MRA 
• Pre-procedural venous ultrasound 
• Review of inclusion/exclusion criteria 
 
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 will consist of the following: 
 
• Subject’s demographic data (sex and date of birth) 
• Medical history 
• Rutherford score and Ankle-Brachial Index (ABI) 
• Serum pregnancy test 
• Venous Clinical Severity Score 
• Villalta scale 
• BUN and Creatinine 
• Medication history and review 
 
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 procedural evaluation will consist of the following: 
 
• Lesion length 
• Lesion calcification (TASC II Classification) 
• Lesion type 
• Procedure time 

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          STP115-F-Version Date 23-Feb-2017                                                                                               Page 36 of 61 
 
• Access sites used 
• Number of attempts to create each anastomosis 
• Complications or adverse events 
 
 
9.4 
Discharge Evaluation 
 
The discharge evaluation will consist of: 
 
• Rutherford score and Ankle-Brachial Index (ABI) 
• Arterial and Venous duplex-ultrasound assessment 
• Complications or adverse events 
• Concomitant medications 
 
9.5 
Follow-Up Evaluation 
 
The evaluations at 1  m o n t h  (±7 days), 3 months (±14 days), 6 months (±30 
days),  12 months (±45 days), 18 months (±45 days) 24 months (±60 days), 30 
months (±60 days) and 36 months (±60 days) post-procedure or when a subject 
withdraws prematurely from the study will consist of: 
 
• Rutherford score and Ankle-Brachial Index (ABI) 
• Venous Clinical Severity Score58 
• Villalta Scale59 
• Arterial and Venous duplex-ultrasound assessment 
• Complications and adverse events 
• Concomitant medications 
 
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 returned 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 

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or its designated representative will conduct device reconciliation at the 
completion of subject enrollment or at the conclusion of the study. 
 
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 System 
to access, deliver guidewires and implant stent grafts for a percutaneous fem-pop 
bypass.  
 
The study is a feasibility study with no formal hypothesis testing and therefore no 
required sample size.  Study results will be presented using descriptive statistics.  
Results from this study will be used to design additional clinical studies. 
 
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. 
 
Primary Safety Endpoint Reporting: 
 
Safety assessment is achieved by recording and measuring Major Complication 
rates/Serious Adverse Event rates associated with the PQ Bypass procedure. The 
number and percentage 6-month MAE will be presented using descriptive Statistics. 
Using the Score approximation, the one-sided upper 95% confidence bound will be 
calculated and presented. 
 
Primary Performance Endpoint Reporting: 
 
Descriptive statistics of the primary performance endpoint which includes total 
number of patent PQB grafts, number and percentage of patent PQB 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 compared to the 
performance goal of 70% (80% historical control rate – 10% Delta.) 
 
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 of Procedural Success, Clinical Success and Technical 

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Success will be summarized by providing point estimates, number of subjects, and 
95% confidence bounds calculated using the Score approximation. 
 
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. 
 
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. 
 
11.2     Sample Size Justification 
 
The sample size chosen for this study has been updated from 60 to 100 patients. The 
sample size was chosen to demonstrate statistically non-inferiority of the PQ Bypass 
Systems performance as compared to results previously reported in similar studies: 
 
 
• for intravascular stent grafts (e.g. Gore Viabahn) – n=60  
• for prosthetic surgical bypass - n=100 
 
A larger sample size is required as prosthetic surgical bypass outcomes are superior 
to those of intravascular stent grafts. 
 
Stent Graft Studies  
Clinical data published on existing stent graft techniques for treating 
femoropopliteal disease have reported 6-month primary patency rates of 
approximately 80%.37,40-42,45, 60, 61 . This average success rate has been used as the 
historical control for the current study.  The standard error reported in the cited 
studies range from 3% to 12%; the lower limit of one-sided 95% confidence 
intervals (CI) is approximately 68%. 
 
In order to establish a sample size, a margin of non-inferiority, delta, was set at 10% 
for the current study to demonstrate non-inferiority of the PQ Bypass Systems to 
the historical control in terms of patency.  This delta reflects the diversity of the 
lesions to be enrolled in this study and the range of reported performance using 
similar technology; 6-month primary patency in the studies cited above ranges from 
27% to 92%, average lesion lengths range from 9-25cm and the percent occlusions 
included ranges from 50% to 100%. Due to this wide variety of lesions reported in 
the literature and the potential diversity of patients and lesion lengths that will be 
enrolled in this study, a 10% delta is adequate to accurately reflect non- inferiority. 
This delta sets up a comparison between the lower 95% CI of the PQ Bypass 
Systems performance to the lower 95% CI reported for the competitive products 
(~70%). 
 
As such using as historical control rate of 80% and a non-inferiority margin of 10%, 

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          STP115-F-Version Date 23-Feb-2017                                                                                               Page 39 of 61 
 
the null and alternative hypotheses of the primary performance endpoint can be 
written as: 
 
 
In order to approximate the performance rates for this study, the results from the 
El Camino Hospital (ECH) Study were used. The PQB procedural approach was 
evaluated in the ECH Study. This study used a similar technique to the 
interventional approach utilized in the ECH Study. This study also used a stent graft 
that is very similar to the stent graft used in the ECH Study, the Gore Viabahn Stent 
Graft. Primary patency at 6 months was approximately 90% in the ECH Study. A 
more conservative estimate of 85% performance for the PQ Bypass Systems was 
utilized along with the aforementioned performance goal for the purpose of 
sample size estimation. To achieve 80% power using a one-sided alpha of 0.05, the 
sample size is 50. To adjust for lost to follow-up and to maintain consistency with 
current literature on the use of stent grafts, 60 subjects will be enrolled in this 
study ((Table 11-1). 
 
Table 11-1: Non-Inferiority with PQ Bypass Performance of 85% 
PG 
NI Margin 
5% 
7.5% 
10% 
12.5% 
15% 
80% 
103 
69 
50 
38 
30 
85% 
368 
174 
103 
69 
50 
90% 
- 
1371 
368 
174 
103 
95% 
- 
- 
- 
1371 
368 
 
The sample size was also elected in order to observe the rate of major adverse 
events. The median number of patients enrolled in stent graft trials reported in the 
literature is 59 patients (range 15-144). 
 
 

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Surgical Bypass Studies  
Clinical data published on existing surgical bypass studies for treating 
femoropopliteal disease is more limited quantitatively and qualitively. Most 
importantly, few studies involve doppler-ultrasound assessments of arterial velocity 
as a basis of assessing patency (e.g. peak systolic velocity ratio). However, one 
particular and recent randomized prospective study of the Gore Viabahn stent graft 
vs. prosthetic bypass surgery provides very reliable data set on surgical outcomes 
as illustrated in Table 11-2.  
 
The randomized prospective study was designed to compare the effectiveness of 
treating superficial femoral artery occlusive disease percutaneously with expanded 
polytetrafluoroethylene (ePTFE)/nitinol self-expanding stent grafts vs surgical 
femoral-to-above knee (AK) popliteal artery bypass with synthetic graft material. 
Methods: From March 2004 to May 2005, 100 limbs in 86 patients with femoral-
popliteal arterial occlusive disease were identified. Patients had symptoms ranging 
from claudication to rest pain, with or without tissue loss, and were prospectively 
randomized for treatment into one of two groups. The limbs were treated 
percutaneously with angioplasty and one or more self-expanding stent grafts (n=50) 
or surgically with femoral-to-AK popliteal artery bypass using synthetic Dacron or 
ePTFE grafts (n=50). 
 
The mean and SD total length of artery stented was 25.6 and 15 cm. Follow-up 
evaluation with ankle-brachial indices and color flow duplex sonography imaging 
were performed at 3, 6, 9, and 12 months after treatment.  
 
Patients were monitored for a median of 18 months. No statistical difference was 
found in the primary patency (P=895) or secondary patency (P=.861) between the 
two treatment groups. Primary patency at 3, 6, 9, and 12 months of follow-up was 
84%, 82%, 75.6%, and 73.5% for the stent graft group and 90%, 81.8%, 79.7%, and 
74.2% for the femoral-popliteal surgical group. Thirteen patients in the stent graft 
group had 14 re-interventions, and 12 re-interventions occurred in the surgical 
group. This resulted in secondary patency rates of 83.9% for the stent graft group 
and 83.7% for the surgical group at the 12-month follow-up (Table 11-2). 
 
Based on review of the limited literature and the recent long lesion stent graft vs 
prosthetic surgery randomized study 6-month surgical bypass primary patency rate 
of 82-85% can be extrapolated.  
 
 
 
 
 
 
 
 
 

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          STP115-F-Version Date 23-Feb-2017                                                                                               Page 41 of 61 
 
 
Table 11-2 Randomized Comparison of 
Viabahn Stent Graft vs. Prosthetic Surgery   
 
Kedora et al J Vasc Surg 2007;45:10-16 
McQuade et al J Vasc Surg. 2009 Jan,49(1):109-15 
 
In order to establish a sample size, a margin of non-inferiority, delta, was set at 10% 
for the current study to demonstrate non-inferiority of the PQ Bypass Systems to 
the historical control in terms of patency. This delta reflects the limited 
quantitative and qualitative availability of fem-pop bypass studies in the 
literature. Therefore, a 10% delta is adequate to accurately reflect non- 
inferiority. This delta sets up a comparison between the lower 95% CI of the PQ 
Bypass Systems performance to the lower 95% CI reported for the competitive 
products (~70%). 
 
As such using as historical control rate of 80-85% and a non-inferiority margin of 10%, 
the null and alternative hypotheses of the primary performance endpoint can be 
written as: 
 
 
 

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          STP115-F-Version Date 23-Feb-2017                                                                                               Page 42 of 61 
 
 
 
 
A conservative estimate of 85% performance for the PQ Bypass Systems was utilized 
along with the aforementioned performance goal for the purpose of sample size 
estimation. To achieve 80% power using a one-sided alpha of 0.05, the maximum 
sample size required is 103 subjects. As the surgical patency rate is extrapolated 
to be between 82% and 85% and since no loss to follow-up is expected in the study, 
a sample size of 100 subjects should be sufficient and enrolled in this study 
(Table 11-3). 
 
Table 11-3: Non-Inferiority with PQ Bypass Performance of 85%  
PG 
NI Margin 
5% 
7.5% 
10% 
12.5% 
15% 
80% 
103 
69 
50 
38 
30 
85% 
368 
174 
103 
69 
50 
90% 
- 
1371 
368 
174 
103 
95% 
- 
- 
- 
1371 
368 
 
12.0 
ADVERSE EVENTS 
 
The occurrence of Adverse Events will be monitored during this study. All Adverse Events 
will be recorded on the Complication/Adverse Event Form at onset and at each 
follow-up visit until resolved.  
 
Potential adverse events associated with use of the Stent Graft System (SGS) 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  
• 
Inflammation 
• 
Malposition 
• 
Myocardial infarction 
• 
Radiation injury 
• 
Renal insufficiency/failure due to excessive 

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• 
Death 
• 
Device failure 
• 
Embolism 
• 
Fever/pain in absence of infection 
• 
Infection  
 
contrast load  
• 
Sepsis 
• 
Shock 
• 
Side branch occlusion 
• 
Stenosis or Occlusion 
• 
Thrombosis 
• 
Vessel dissection, perforation or wall trauma 
 
Potential adverse events associated with use of the Guidewire Delivery System (GWDS) 
include, but are not limited to the following:  
 
• 
Access site hemorrhage or hematoma  
• 
Access site pain  
• 
Acute vessel closure 
• 
Bleeding complications 
• 
Vessel dissection, perforation or wall 
trauma 
 
• 
Death 
• 
Embolism 
• 
Infection  
• 
Renal insufficiency/failure due to excessive 
contrast load 
 
Potential adverse events associated with use of the Balloon Dilator (BD) include, but are 
not limited to the following: 
 
• 
Hemorrhage or hematoma  
• 
Hypotension 
• 
Pain  
• 
Arrhythmias 
• 
Systemic embolization 
• 
Endocarditis 
• 
Pyrogenic reaction 
• 
Acute vessel closure 
• 
Vascular Thrombosis 
• 
Bleeding complications 
• 
Sepsis/Infection  
• 
Short term hemodynamic deterioration 
• 
Drug reactions, allergic reaction to contrast media 
• 
Aneurysm or pseudoaneurysm formation 
• 
Death 
• 
Renal insufficiency/failure due to excessive contrast 
load 
• 
Vessel dissection, perforation or wall trauma  
• 
Potential balloon separation following rupture or 
abuse and subsequent need to use a snare or other 
medical interventional techniques to retrieve the 
pieces 
 
 
To meet the objectives of this study, the following definitions will apply. (Definitions 
reference ISO 14155:2011-01) 
 
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. 

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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 
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, or 
could have led, 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 
o a life-threatening illness or injury, or 
o a permanent impairment of a body structure or a body function, or 
o in-patient or prolonged hospitalization, or 
o medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body 
function. 
 o   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 Adverse Device Effect (UADE) 
 
Unanticipated Serious Adverse Device Effect (USADE): Serious adverse device 

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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. 
 
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. 
 
 
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 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. 
 

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Reporting of SAEs to the Austrian competent authority (BASG) occurring e occurred 
in Austria will be done performed using form F-I208 which is provided on the 
homepage: 
 
http://www.basg.gv.at/medizinprodukte/klinische-pruefung-von-medizinprodukten/. 
 
For all SAEs occurring outside of Austria, a rolling registration form has to be used 
(tabular listing = line listing): FI287. In addition, the reporting requirements 
pursuant to § 70 MPG as amended, will be observed. 
 
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. 
 
Sponsor Representative Contact 
Claire van den Nieuwenhof 
Quality Manager 
 
HealthLink Europe BV 
HealthLink International Inc. 
De Tweeling 20-22 
5215 MC ‘S Hertogenbosch 
The Netherlands 
 
Phone General: +31-(0)13-5479300 
Fax: +31-(0)13-5479300 
E-mail: claire.vandennieuwenhof@healthlinkeurope.com 
 
The Sponsor will ensure compliance with all country-specific reporting 
requirements to the appropriate Ethical Committees and Competent Authorities. 
In Germany, the Sponsor shall use form ‘Meldeformular_Klinishe_Pruef_SAE.pdf’ 
as specified by German Medical Device Safety Regulation. The e-mail to be used 
when submitting the SAE notification form is  MPSAE@BFARM.de. SAEs should be 
reported immediately and no later than 30 days from the Sponsor’s first knowledge 
of the event. 
 
 
 
 
 

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13.0 
MONITORING 
 
The Sponsor or its designated representative, qualified by training and experience, will be 
responsible for monitoring and overseeing the conduct of the trial.  The accuracy of all 
collected data will be verified (100% monitoring) for: 
 
• Eligibility criteria 
• Baseline characteristics 
 
 
• Primary safety and performance endpoints 
• Adverse events 
• Secondary endpoints 
 
with source documents including, but not limited to, medical records, office/clinic notes, 
procedure reports, laboratory results, physician and nursing progress notes. Verification 
and quality of data, monitoring of clinical study progress and Investigator compliance with 
the approved protocol will be conducted by the study Sponsor or its designated 
representative. 
 
The study Sponsor or its designated representative must be allowed to visit the clinical site 
and have direct access to all study records throughout the duration of the study. The 
monitor will review all source data and compare them to the data documented in the case 
report forms, in addition to performing a review of the Regulatory Binder, and conducting 
device accountability. The Investigator and/or institution will provide direct access to 
source data/documents for trial-related monitoring, audits, EC review and regulatory 
inspection. 
 
It is important that the Investigator and relevant study personnel are available during the 
monitoring visits and that sufficient time is devoted to the process. 
 
Additionally, telephone and/or e-mail contact will be conducted on a regular basis with 
the Investigator and the site staff to ensure that the protocol is being followed and to 
address any issues that may occur during the course of the trial. 
 
If a deficiency is noted during the course of the trial the clinical monitor is required to 
discuss the situation with the site and the Sponsor (if required) to secure compliance. 
 
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 

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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 concomitant 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 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. 
 
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     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. 
 
 
 
 
16.3     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 should be submitted to the Ethics 
Committee for either notification or approval. 
 
Regulatory approvals must be obtained prior to enrolment of the first patient. The 
Sponsor will arrange regulatory and local approvals for the study. The Sponsor or 
its designated CRO (HealthLink, Inc ) will require a copy of any EC and CA 
correspondence, as well as the final approval letter from the EC and CA, where 
applicable. 
An Investigator may not make protocol changes without prior approval by Sponsor. 
All significant protocol changes that may affect the following must be submitted 
and approved by the EC and CA before initiating the change: 
• Validity of the data or information resulting from the completion of the 
approved protocol 
• Relationship of the likely subject risk to benefit relied upon to approve the 
protocol 
• Scientific soundness of the investigational plan 
• Rights, safety, or welfare of the human subjects involved in the 
investigation 
The change must be approved by the relevant EC and CA. The sponsor will submit a 
copy of the protocol amendment to all Investigators for their EC to review and 
ensure the study continues to be conducted consistently across all sites. The 
investigative sites must send the Sponsor a copy of the approval letter for the 
protocol amendment. 
The Sponsor may make certain administrative changes to the protocol without prior 
approval of the relevant EC and CA. The Sponsor will notify all investigative sites of 

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such changes to ensure the study continues to be conducted consistently across all 
sites. The site EC will be notified of these changes 
 
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. 
 
 
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 

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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.  
A description of this clinical trial is available on http://www.ClinicalTrials.gov.  The ClinicalTrials.gov 
identifier is NCT02471638. 
19.0 
DEFINITIONS 
 
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  
• 
Major Blood Loss   - Defined as transfusion of >2 units packed red blood cells (PRBC)).  
• 
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.  

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Clinical Success  
Improvement of at least one category using the Rutherford Clinical Severity Scale. 
 
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.   
• 
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.   
Deep Vein Thrombosis (DVT) on Ipsilateral Limb 
A blood clot (thrombus) in the targeted deep vein (e.g. posterior tibial). A deep vein thrombosis is 
symptomatic. A deep vein thrombosis is distinct from the presence of mild fibrin/thrombus with 
no hemodynamic impact or the intentional l occupancy of the vein by the graft or asymptomatic 
occlusive thrombus (see Venous Classification below) 
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. 
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 > 2 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 2 years. 
Malignant Tumor1 
A tumor that invades surrounding tissues, is usually capable of producing metastases, may recur after 
attempted removal, and is likely to cause death of the host unless adequately treated. 
Major Adverse Event (MAE)  
                                                          
1 http://www.medilexicon.com 

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Composite endpoint of death, target vessel revascularization (TVR) or any amputation of the index 
limb.  See individual events for detailed definitions.  
Major Adverse Vascular Event (MAVE)  
Composite endpoint of 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. 
 
Myocardial Infarction (MI) 
2 
Typical chest pain and either a Q-wave or non Q-wave MI as described below.  Myocardial infarction 
is a component of MAE. 
• 
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 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 
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.  
Primary Patency 
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). 
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.  
Procedural Success 
Successful delivery of the investigational devices to the identified area and removal of delivery 
system.  in the absence of in-hospital MAEs. 
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. 
                                                          
2 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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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 
procedure to treat an adverse event related to the disease, the index procedure or the study device.  
Secondary Patency 
revascularization of occlusion (100%) within the stent graft or immediately above or below the 
treated arterial segment with less than 50% residual stenosis  
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)  
• 
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 on the index lesion site. 
Target Vessel Revascularization (TVR) 
Treatment of another lesion at the target vessel site. 
Technical Success 
Successful delivery of the investigational devices to the identified area and 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 

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Method of entry into the vascular system.  Categorized as either surgical cut down or percutaneous.   
 
Venous Classification (Miller Scale) 
A means of classifying observations in the deep vein in which the stent graft is implanted:   
• 
0: Patent, no presence of fibrin or thrombus 
• 
1: Patent, thin film fibrin sheath 
• 
2: Patent, presence of mild fibrin/thrombus without hemodynamic impact  
a) located in gutter adjacent to anastomosis 
  
b) located in body of graft 
• 
3: Intentional occupation of vein with no anticipated flow 
• 
4: Asymptomatic Occlusive thrombosis  
 
 
 
 
 

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20.0 
REFERENCES 
 
 
 
1 American Heart Association. What is PAD? Available at: 
http://www.americanheart.org/print_presenter.jhtml?identifier=3020249. Accessed June 3, 2013. 
2 National Institutes of Health. National Heart, Lung, and Blood Institute. Diseases and Conditions Index. What is 
Atherosclerosis? Available at: 
http://www.nhlbi.nih.gov/health/dci/Diseases/Atherosclerosis/Atherosclerosis_WhatIs.html. Accessed June 3, 
2013. 
3Chi Y and Jaff M. Optimal risk factor modification and medical management of the patient with peripheral arterial 
disease. Catheterization and Cardiovascular Interventions. 2008;71(4);475-89. 
4Bashir R and Cooper C. Evaluation and medical treatment of peripheral arterial disease. Current opinion in 
cardiology. 2003;18(6):436-43. 
5Gornik H and Beckman J. Peripheral Arterial Disease. Circulation. 2005;111;e169-e172. 
6 Alber M, Romiti M, Brochado-Neto FC, et al. Meta-analysis of alternate autologous veins bypass grafts to 
infrapopliteal arteries. J Vasc Surg. 2005;42:449-55. 
7 TASC Classification Consensus Document on PAD – 2000. 
8 Norgren L, Hiatt WR, Dormandy JA, et al. TASC II Working Group. Inter-Society Consensus for the Management of 
Peripheral Arterial Disease (TASCII). J Vasc Surg. 2007;45(Suppl S):S5-S67. 
9 Schillinger M, Diehm N, Baumgartner I and Milnar E. TASC II Section F on Revascularization: Commentary From an 
Inverventionalist’s Point of View. J Endovasc Ther. 2007;14:734-742. 
10 Diehm N, Schillinger M, Milnar E, et al. TASC II E3 on the Treatment of Acute Limb Ischemia: Commentary from 
European Interventionalists. J Endovasc Ther. 2008;15:126-128. 
11 Lyden SP and Smouse HB. TASC II and the Endovascular Management of Infrainguinal Disase. J Endovasc Ther. 
2009;16(Suppl II):II5-II18. 
12 Goodney PP, Beck AW, Nagle J, et al. National trends in lower extremity bypass surgery, endovascular 
interventions, and major amputations. J Vasc Surg. 2009;50:54-60. 
13 Vroegindewij D, Vos LD, Tieldbeek AV, et al. Balloon Angioplasty Combined with Primary Stenting Versus Balloon 
Angioplasty Alone in Femoropopliteal Obstructions: A comparative Randomized Study. Cardiovasc Intervent Rad. 
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14 Cejna M, Thurnher S, Illiasch H, et al. PTA versus Palmaz Stent Placement in Femoropopliteal Artery Obstructions: 
A Multicenter Prospective Randomized Study. J Vasc Interv Radiol. 2001;12:23-31. 
15 Becquemin JP, Farve JP, Marzelle J, et al. Systematic versus selective stent placement after superficial femoral 
artery balloon angioplasty: a multicenter prospective randomized study. J Vasc Surg. 2003;37:487-494. 
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Stent Placement for Femoropopliteal Lesions. J Vasc Interv Radiol. 2001;12:935-941. 
17 Clark TWI, Groffsky JL and Soulen MC. Predictors of Long-term Patency after Femoropopliteal Angioplasty: Results 
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18 Krakenberg H, Schluter M, Steinkamp HJ, et al. Nitinol Stent Implantation Versus Percutaneous Transluminal 
Angioplasty in Superficial Femoral Artery Lesions up to 10 cm in Length. The Femoral Artery Stenting Trial (FAST). 
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19 Schillinger M, Exner M, Mlekusch W, et al. Vascular Inflammation and Percutaneous Transluminal Angioplasty of 
the Femoropopliteal Artery: Association with Restenosis. Radiology. 2002;225:21-26. 
20 Laird JR, Katzen BT, Scheinert D, et al. Nitinol Stent Implantation Versus Balloon Angioplasty for Lesions in the 
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Trial. Circ Cardiovasc Interv. 2010;3:267-276. 
21 PMA Summary of Safety and Effectiveness for P040037, W.L. Gore Viabahn Endoprosthesis. 2005. 

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22 Saxon RR, Coffman JM, Gooding JM, et al. Long-term Results of ePTFE Stent-Graft versus Angioplasty in the 
Femoropopliteal Artery: Single Center Experience from a Prospective, Randomized Trial. J Vasc Interv Radiol. 
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23 Van Der Zaag ES, Legemate DA, Prins MH, et al. Angioplasty or bypass for Superficial Femoral Artery Disease? A 
Randomised Controlled Trial. Eur J Vasc Endovasc Surg. 2004;28:132-137. 
24 Schillinger M, Sabeti S, Loewe C, et al. Balloon Angioplasty versus Implantation of Nitinol Stents in the Superficial 
Femoral Artery. N Engl J Med. 2006;354:1879-88. 
25 Cheng SWK, Ting ACW and Ho P. Angioplasty and Primary Stenting of High-grade, Long-segment Superficial 
Femoral Artery Disease: Is it worthwhile? Ann Vasc Surg. 2003;17:430-437. 
26 Kougias P, Chen A, Cagiannos C, et al. Subintimal placement of covered stent versus subintimal balloon 
angioplasty in the treatment of long-segment superficial femoral artery occlusion. Amer Jour Surg. 2009;198:645- 
649. 
27 Yilmaz S, Sindel T, Yegin A, et al. Subintimal Angioplasty of Long Superficial Femoral Artery Occlusions. J Vasc 
Interv Radiol. 2003;14:997-1010. 
28 Parsons RE, Suggs WD, Lee JJ, et al. Percutaneous transluminal angioplasty for the treatment of limb threatening 
ischemia: do the results justify an attempt before bypass grafting? J Vasc Surg. 1998;28:1066-71. 
29 Schlager O, Dick P, Sabeti S, et al. Long-Segment SFA Stenting – the Dark Sides: In-Stent Restenosis, Clinical 
Deterioration, and Stent Fractures. J Endovasc Ther. 2005;12:676-684. 
30 Gordon IL, Conroy RM, Arefi M, et al. Three-Year Outcome of Endovascular Treatment of Superficial Femoral 
Artery Occlusion. Arch Surg. 2001;136:221-228. 
31 Sabeti S, Mlekusch W, Amighi J, et al. Primary Patency of Long-segment Self-Expanding Nitinol Stents in the 
Femoropopliteal Arteries. J Endovasc Ther. 2005;12:6-12. 
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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. 
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54 Lindholt JS, Gottschalksen B, Johannsen N, et al. The Scandinavian Propaten Trial – 1-Year Patency of PTFE 
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56 Johnston, PC, Vartanian, SM, Runge, SJ et al. Risk factors for clinical failure after stent graft treatment for 
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57 http://www.nlm.nih.gov/medlineplus/ency/patientinstructions/000234.htm 
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60 Wiesinger B, Beregi JP, Olivia VL, et al. PTFE-Covered Self-Expanding Nitinol Stents for the Treatment of Severe 
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May not be reproduced without written permission from PQ Bypass, Inc. 
 
          STP115-F-Version Date 23-Feb-2017                                                                                              Page 60 of 61 
 
 
 
 
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. 
 
          STP115-F-Version Date 23-Feb-2017                                                                                                Page 61 of 61 
 
 
 
 
APPENDIX II: INSTRUCTIONS FOR USE 
 
 
 
(Attached as separate documents)