The Detour Endovascular Technique for Long OcclUsive Fem-pop Revascularization - 2 Clinical Trial
Phase: NA
Conditions: Peripheral Arterial Disease
Sponsor: Endologix

 
 
 
 
 
 
 
 
The DETOUR 2 Clinical Trial 
 
 
The Detour Endovascular Technique for long OcclUsive fem-pop Revascularization – 2 
Clinical Trial 
 
 
 
Protocol Number:  STP 203 Rev. F 
 
 
 
Sponsor: 
PQ Bypass, Inc. 
1971 Mimont Drive 
Milpitas, CA 95035 
 
 
 
Issue Date:    16 March, 2020 
 
CONFIDENTIAL 
 
 

THE DETOUR 2 CLINICAL TRIAL 
 
VERSION REV.F 
PROTOCOL NO.  STP 203 
 
 16 MARCH, 2020 
CLN 114 Rev F 
Proprietary confidential information. ©2019 PQ Bypass, Inc. All rights reserved. 
Page 2 of 83 
 
INVESTIGATOR SIGNATURE PAGE 
 
 
STUDY TITLE: 
The Detour Endovascular Technique for long OcclUsive fem-pop 
Revascularization – 2 Trial (The DETOUR 2 Clinical Trial) 
 
PROTOCOL NUMBER 
& ISSUE: 
 
STP 203 Rev. F 
 
STUDY CENTER: 
 
_____________________________________________ 
(Print name of study center) 
 
 
 
I, the undersigned, have read and understand the protocol specified above and agree 
with its content. I agree to perform and conduct the Study as described in the protocol. 
In addition, when applicable, I agree to enlist sub-investigators who also agree to 
perform and conduct the Study as described in the protocol. I will provide copies of this 
Protocol and all pertinent information to the Study personnel under my supervision and 
my hospital Institutional Review Board/Ethics Committee. I will discuss this material 
with them and ensure they are fully informed regarding the PQ Bypass investigational 
device and the conduct of the Study according to Good Clinical Practice (GCP), 
Declaration of Helsinki, 21 CFR Parts 50, 54, 56 and 812, ISO 14155:2011 (OUS centers 
only), and any local regulations. 
 
 
 
 
 
 
 
 
Site PI Name:   
________________________________ 
 
 
Site PI Signature:  __________________________________    Date:  ______________ 
 

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TABLE OF CONTENTS 
PRIMARY STUDY CONTACTS ............................................................................................... 1 
EXECUTIVE SUMMARY ...................................................................................................... 2 
1.0 
INTRODUCTION ...................................................................................................... 2 
1.1 
BACKGROUND AND RATIONALE ........................................................................... 2 
1.2 
DEVICE DESCRIPTION ........................................................................................ 2 
1.3 
REGULATORY STATUS ........................................................................................ 5 
1.4 
PROPOSED INTENDED USE ................................................................................. 5 
1.5 
CE MARK STUDY – DETOUR I ............................................................................. 5 
1.6 
RISKS AND BENEFITS ....................................................................................... 10 
2.0 
TRIAL OBJECTIVES ................................................................................................. 11 
3.0 
SELECTION AND WITHDRAWAL OF SUBJECTS ................................................................ 12 
3.1 
INCLUSION CRITERIA ....................................................................................... 12 
3.2 
EXCLUSION CRITERIA ....................................................................................... 13 
3.3 
WITHDRAWAL OF SUBJECTS ............................................................................. 15 
4.0 
TRIAL DESIGN ...................................................................................................... 15 
4.1 
DESCRIPTION OF TRIAL DESIGN ......................................................................... 15 
4.2 
TRIAL ENDPOINTS ........................................................................................... 15 
4.3 
SAMPLE SIZE ................................................................................................. 20 
4.4 
INVESTIGATIONAL SITES ................................................................................... 20 
4.5 
DURATION OF SUBJECT PARTICIPATION............................................................... 20 
4.6 
EARLY STUDY TERMINATION ............................................................................. 20 
4.7 
WRITTEN INFORMED CONSENT ......................................................................... 21 
4.8 
ENROLLMENT ................................................................................................ 21 
4.9 
STUDY PROCEDURES ....................................................................................... 21 
5.0 
ASSESSMENT OF EFFICACY ....................................................................................... 25 
5.1 
PRIMARY EFFECTIVENESS ENDPOINT .................................................................. 26 
6.0 
ASSESSMENT OF SAFETY ......................................................................................... 26 
6.1 
PRIMARY SAFETY ENDPOINT ............................................................................. 26 
7.0 
STATISTICS .......................................................................................................... 26 
7.1 
STATISTICAL HYPOTHESES AND SAMPLE SIZE JUSTIFICATION .................................... 26 
7.2 
ANALYSIS POPULATIONS .................................................................................. 28 
7.3 
GENERAL STATISTICAL CONSIDERATIONS ............................................................. 29 
7.4 
EFFICACY ANALYSES ........................................................................................ 31 
7.5 
SAFETY ANALYSES........................................................................................... 32 
7.6 
SECONDARY ENDPOINTS AND ADDITIONAL ANALYSES ............................................ 32 
7.7 
FINAL CLINICAL REPORT ................................................................................... 32 
8.0 
SPONSOR RESPONSIBLITIES ..................................................................................... 32 
8.1 
GENERAL DUTIES ............................................................................................ 33 
8.2 
SELECTION OF CLINICAL SITES & INVESTIGATORS .................................................. 33 
8.3 
MONITORING ................................................................................................ 33 
8.4 
INVESTIGATIONAL SITE TERMINATION ................................................................. 35 

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8.5 
INFORMED CONSENT & INSTITUTIONAL REVIEW BOARD (IRB) / ETHICS COMMITTEE (EC)
................................................................................................................... 35 
8.6 
RECORDS & RECORD RETENTION ...................................................................... 35 
8.7 
STUDY REPORTS ............................................................................................. 36 
8.8 
SUPPLEMENTAL APPLICATIONS .......................................................................... 36 
9.0 
QUALITY ASSURANCE & ETHICAL STANDARDS .............................................................. 36 
9.1 
TRIAL CONDUCT ............................................................................................. 36 
9.2 
INSTITUTIONAL REVIEW BOARDS / ETHICS COMMITTEES ........................................ 36 
9.3 
INFORMED CONSENT ...................................................................................... 37 
9.4 
PROTOCOL AMENDMENTS ............................................................................... 37 
9.5 
EMERGENCY ACTIONS ..................................................................................... 38 
9.6 
DEVIATIONS FROM THE INVESTIGATIONAL PLAN ................................................... 38 
9.7 
INVESTIGATOR & STAFF TRAINING ..................................................................... 39 
9.8 
AUDITS AND INSPECTIONS ................................................................................ 40 
9.9 
MONITORING PROCEDURES .............................................................................. 40 
9.10 
INVESTIGATIONAL DEVICE DISTRIBUTION AND ACCOUNTABILITY .............................. 41 
9.11 
RETURN OF DEVICES ....................................................................................... 42 
9.12 
CENTRAL CORE LABS – ANGIOGRAPHY, DUPLEX ULTRASOUND AND X-RAY ................ 42 
9.13 
COVERAGE OF EXPENSES .................................................................................. 43 
9.14 
CONFIDENTIALITY ........................................................................................... 43 
10.0 INVESTIGATOR RESPONSIBILITIES, RECORDS & REPORTS ................................................. 43 
10.1 
INFORMED CONSENT & INSTITUTIONAL REVIEW BOARD / ETHICS COMMITTEE ........... 43 
10.2 
WITHDRAWAL OF APPROVAL ............................................................................ 44 
10.3 
DEVICE ACCOUNTABILITY ................................................................................. 44 
10.4 
DATA HANDLING AND RECORD KEEPING ............................................................. 44 
11.0 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS ......................................................... 47 
11.1 
ADVERSE EVENTS ........................................................................................... 48 
11.2 
SERIOUS ADVERSE EVENT (SAE) ....................................................................... 49 
11.3 
UNANTICIPATED ADVERSE DEVICE EFFECTS (UADE) ............................................. 50 
11.4 
ADVERSE EVENT REPORTING ............................................................................ 50 
11.5 
REPORTING OF DEVICE FAILURES AND MALFUNCTIONS .......................................... 51 
12.0 CLINICAL EVENTS COMMITTEE .................................................................................. 52 
13.0 DATA SAFETY MONITORING BOARD .......................................................................... 52 
14.0 PUBLICATION POLICY ............................................................................................. 53 
15.0 STUDY DEFINITIONS .............................................................................................. 54 
16.0 BIBLIOGRAPHY ..................................................................................................... 63 
APPENDIX I:  INFORMED CONSENT FORM ............................................................................ 72 
APPENDIX II:  INSTRUCTIONS FOR USE (IFU) ........................................................................ 73 
 
 
 
 

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Protocol Synopsis 
 
The Detour Endovascular Technique for long OcclUsive fem-pop Revascularization – 2    
Clinical Trial 
 
Protocol Number: STP 203 REV. F 
IDE Number: G170083 
National Clinical Trial (NCT) Identified Number:  NCT03119233 
 
Co-Principal Investigators: 
Sean Lyden, MD, Cleveland Clinic Foundation, Cleveland, OH, USA 
Jihad Mustapha, MD, Advanced Cardiac and Vascular Centers, Grand Rapids, MI, USA 
 
CT, DUS, Angiographic, and X-Ray Imaging Core Laboratory: 
Cleveland Clinic Peripheral Core Laboratory - Paul Bishop, Beachwood, OH, USA 
 
Clinical Events Committee (CEC) and DSMB: 
Syntactx - Kenneth Ouriel, MD, New York, NY, USA 
 
Health Economics Core Laboratory: 
Wing Tech Inc. - Jan B. Pietzsch, Ph.D., Menlo Park, CA, USA 
 
EU Authorized Representative: AngioPro, Speyer, Germany 
 
Sponsor: PQ Bypass, Inc. 
Heather Simonsen, Senior Vice President & General Manager 
1971 Milmont Drive, Milpitas, CA 95035, USA 
 
 
Electronic Data Capture Platform (EDC): 
Mednet, Plymouth, MN, USA 
 
Image Transfer Platform: Medidata Rave Imaging, New York, NY, USA 
 
Version Number:  Rev. F 
 
 
 

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July 31, 2019 
 
PROTOCOL SYNOPSIS 
Sponsor Name: 
PQ Bypass, Inc. 
Title: 
The DETOUR 2 Clinical Trial -  The Detour Endovascular 
Technique for long OcclUsive fem-pop Revascularization – 2 
Clinical Trial 
Study Description: 
Prospective, single-arm, multi-center, international clinical 
investigation to evaluate the safety and effectiveness of the 
PQ Bypass System to access, deliver guidewires, and implant 
stent grafts for a percutaneous femoropopliteal (fem-pop) 
bypass. 
Study Objective: 
The safety and effectiveness of the PQ Bypass System will be 
established by comparing the primary safety and effectiveness 
endpoints in the IDE Study to safety and effectiveness 
Performance Goals (PG). 
Primary Endpoints: 
Primary Efficacy Endpoint 
The absence of clinically-driven target lesion revascularization 
and absence of recurrent target lesion diameter stenosis >50% 
by imaging (e.g., duplex ultrasound peak systolic velocity ratio 
of >2.5 or invasive angiography) within the stent or 
immediately 1 cm above or below the treated segment.  When 
both modalities are available, angiography takes precedence.   
Primary Safety Endpoint 
Freedom from a major adverse event (MAE) at 30 days post-
procedure defined as any occurrence of the following events: 
Death, Clinically-Driven Target Lesion Revascularization (CD-
TLR), Amputation of the Treated Limb, Symptomatic Deep Vein 
Thrombosis (DVT), Pulmonary Embolism, or procedure-related 
bleeding requiring any transfusion of packed red blood cells or 
surgery. 
Study Population: 
202 subjects and up to 80 roll-in subjects 
• Rutherford 3 to 5 
• Complex TASC C and TASC D lesions 
• Reference Vessel Diameter 4.5 - 6.7 mm 
Clinical Sites: 
A maximum of 40 US sites and 10 OUS sites.  

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Description of Study 
Intervention:  
Investigational Device 
PQ Bypass designs and manufactures the PQ Bypass System: 
comprised of the TORUS Stent Graft System, the PQ Crossing 
Device and the PQ Snare, which allows a percutaneous bypass 
procedure in the peripheral vasculature.  
Investigational Procedure 
Medical history and imaging performed within the previous 
180 days may be used for this initial eligibility evaluation. 
Subjects are required to undergo study related exams, to 
include venous duplex ultrasound, before the start of the 
interventional procedure. Patient eligibility will be confirmed 
via angiography prior to insertion of the study devices. 
Investigators will access the target lesion and the 
corresponding ipsilateral vein using standard percutaneous 
techniques and devices.  
After eligibility confirmation, the PQ Crossing Device and the 
PQ Snare 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.  
TORUS Stent Grafts 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 apposition, ensuring that the balloon is only 
inflated within the TORUS Stent Graft lumen. 
Participant 
Duration: 
Subjects will return to the study center at 1 month (30 days ±7 
days), 6 months (180 days ±30 days), 12 months (360 days ±30 
days), 24 months (720 days ±60 days), and 36 months (1080 
days ±60 days) following the procedure for a follow-up 
evaluation. During these visits, subjects will undergo lower-
extremity arterial and venous duplex ultrasounds, venous 
health questionnaires, QOL surveys, walk test (sub-group of 
study subjects), and be examined for any post-procedural 
complications or adverse events. 
 
Inclusion Criteria: 
General Inclusion Criteria 
1. Age > 18 and ≤ 90 years of age. 
2. Willing and able to provide informed consent.  

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3. Subject is willing to undergo all follow-up assessments 
according to the specified schedule over 36 months. 
Clinical Inclusion Criteria 
4. Chronic, symptomatic lower limb ischemia defined as 
Rutherford clinical categories 3, 4, or 5. 
5. Venous Clinical Severity Score < 3. 
6. Subject is a suitable candidate for angiography and 
endovascular intervention and, if required, is eligible for 
standard surgical repair. 
Angiographic Inclusion Criteria 
7. Symptomatic femoropopliteal chronic total occlusions ≥ 20 
cm (TASC D) that can include de novo, restenotic, or in-
stent restenotic lesions; or 
Symptomatic femoropopliteal lesions ≥ 24 cm (total lesion 
length) that can include a chronic total occlusion or a ≥70% 
lesion that includes de novo, restenotic or in-stent 
restenosis (complex TASC C), by investigator visual 
assessment. 
8. Reference vessel diameter ≥ 4.5 and ≤ 6.7 mm, by 
investigator visual assessment. 
9. Subject has a patent popliteal artery (<50% stenosis) distal 
to the landing zone 
10. Able to successfully access the SFA origin for entry of the 
crossing device. 
11. At least one patent infrapopliteal vessel (<50% stenosis) 
with run-off to the ankle or foot. 
12. A significant stenosis (≥ 50%) or occlusion of an ipsilateral, 
inflow artery (e.g. aortoiliac, common femoral) must be 
successfully treated (use of investigational treatment 
prohibited) prior to treatment of the target lesion. 
Successful treatment is defined as no complications and 
less than 30% residual stenosis following intervention. 
Exclusion Criteria: 
General Exclusion Criteria 
1. Participating in another investigational clinical study. 
2. Anticipated life expectancy less than 1 year or medical 
comorbid condition(s) that could limit the subject’s ability 
to comply with the requirements of the trial. 

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3. Subject has other medical, social or psychological problems 
that, in the opinion of the investigator, preclude them from 
receiving this treatment, and the procedures and 
evaluations pre- and post-treatment. 
Clinical Exclusion Criteria 
4. History of deep vein thrombosis on either limb. 
5. Thrombophlebitis, within the previous 30 days. 
6. Planned amputation of the target limb, including minor 
amputations.  
7. Prior distal amputation (above the transmetatarsal) of the 
target limb. 
8. Known or suspected active infection at the time of the 
procedure (e.g., WIfI foot infection grade 3: Severe 
infection. Local infection with systemic inflammatory 
response syndrome [SIRS]). 
9. Rutherford clinical category 0, 1, 2 or 6. 
10. Has acute or chronic renal disease with GFR ≤ 30 ml/min 
per 1.73 m2 and/or elevated serum creatinine >2.5mg/dL 
(220µmol/L) or on dialysis. 
11. Known hypersensitivity/allergy to the investigational 
devices and/or required pharmacotherapy that cannot be 
safely managed. 
12. Morbid obesity that does not allow for safe vascular access 
or imaging. 
13. Subject has a known coagulopathy or has bleeding 
diatheses, thrombocytopenia with platelet count less than 
100,000/microliter or INR > 1.8. 
14. Requires coronary or peripheral procedure within 30 days 
prior to or planned within 30 days post treatment of the 
target lesion. 
15. Has a known history of intracranial bleeding or aneurysm, 
myocardial infarction or stroke within the last 3 months. 
16. Subject is pregnant or breast-feeding. 
Angiographic Exclusion Criteria 
17. Stent within 3 cm of SFA ostium. 
18. Previous bypass surgery on the target limb. 
19. Subject has significant disease or obstruction (≥50%) of the 
inflow tract that has not been successfully treated at the 

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time of the index procedure (success measured as ≤30% 
residual stenosis, without complication) 
20. Presence of aneurysm or acute thrombus in the target 
limb. 
21. Thrombolysis of the target vessel within 72 hours prior to 
the index procedure, where complete resolution of the 
thrombus was not achieved. 

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Table 1: Schedule of Assessments 
Activity 
Initial 
Eligibility 
Pre Procedural 
Baseline Screening Procedure 
Discharge 
Follow-Up Visits 
1M ± 7D 
(30D  ±7D) 
6M ± 30D 
(180D ±30D) 
12M ± 30D 
(360D ±30D) 
24M ± 60D 
(720D ±60D) 
36M ± 60D 
(1080D ±60D) 
Informed Consent/HIPAA (within 30 days of enrollment) 
X 
 
 
 
Review of Inclusion/Exclusion Criteria 
X 
X 
X 
 
Pre-Procedural Imaging1 (CTA, MRA, Angio, etc.) 
X 
 
 
 
Pre-Procedural Venous Ultrasound 
X 
 
 
 
Medical History/Demographics 
X 
 
 
Brief Physical Exam/Health Status 
X 
 
X 
X 
X 
X 
X 
X 
Routine Laboratory Tests (CBC and Chem-7) 
X 
 
 
 
 
 
 
 
Serum Creatinine to Calculate eGFR 
X 
 
 
 
 
 
 
 
Ankle-Brachial Index (or Toe-Brachial Index2) 
X 
 
 
X 
X 
X 
X 
X 
Rutherford Assessment 
X 
 
 
X 
X 
X 
X 
X 
Venous Clinical Severity Score and Villalta Scale 
X 
 
 
X 
X 
X 
X 
X 
Final Eligibility Angiogram/Venogram or venous 
ultrasound3   
 
X 
 
Device Accountability 
 
X 
 
 
 
 
 
 
Venous Ultrasound4 and Venous Observation Scale 
 
 
 
X 
X 
X 
X 
X 
Arterial Ultrasound4 
 
 
 
X 
X 
X 
X 
X 
Stent Graft X-Ray 
 
 
 
 
 
X 
 
 
Adverse Event Assessment 
 
X 
X 
X 
X 
X 
X 
X 
Dual Antiplatelet Therapy5 
X 
X 
X 
X 
X 
X 
X 
X 
VascuQOL 
X 
 
 
X 
 
X 
 
 
EQ-5D-5L QOL 
X 
 
 
X 
 
X 
 
 
SF-12 
X 
 
 
X 
 
X 
 
 
6 Minute Walk Test6 
X 
 
 
X 
 
X 
 
 
1 Pre-procedure imaging performed within 180 days of baseline procedure. 
2 Perform Toe Brachial Index (TBI) only if unable to reliably assess ABI reading.  Tests are performed in resting state.   
3 Angiography performed throughout the index procedure.  Angiography required to be submitted to the angiographic core lab for all target limb revascularization procedures. 
4 Duplex Ultrasound is to be completed at each follow-up visit. 
5 Effective anticoagulation therapy should be maintained throughout the procedure (minimum ACT >250 seconds is recommended). Dual anti-platelet or anti-coagulation therapy 
is recommended for at least three years.  Refer to Section 4.2.10  for full recommendations 
6 The 6-Minute Walk Test is not routinely performed at all clinical sites; therefore, select sites shall complete a 6MWT on select subjects as agreed upon.  This will therefore result 
in a sub-group of clinical sites and subjects and not be studywide. 

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1.0 
INTRODUCTION 
1.1 
BACKGROUND AND RATIONALE 
Systematic reviews indicate that PAD affects more than 200 million 
people worldwide—and the prevalence of PAD is increasing as “baby 
boomers” enter high-risk age groups. The field of endovascular medicine 
has evolved to treat this growing population; however, an effective 
minimally-invasive treatment for long and complex lesions of the 
superficial femoral artery (SFA) remains a significant unmet need. 
Treatment options for patients with long and complex femoropopliteal 
lesions (≥ 24 cm in length, hemodynamically-significant) are not optimal, 
and choosing a treatment strategy for this category of lesion presents a 
clinical dilemma for both the physician and the patient. Endovascular 
devices, while less invasive than open femoropopliteal bypass surgery, 
were initially developed for shorter lesions, and have demonstrated 
reasonable effectiveness in lesions < 20 cm, with 12-month patency rates 
ranging from 76% to 86%. When applied to lesions ≥ 24 cm, however, 
these same endovascular devices have not demonstrated comparable 
medium-term effectiveness, with 12-month patency rates ranging from 
42% to 64%. Complicating factors include: 
• Amplified biologic reaction to treatment 
• Suboptimal luminal gain with high residual resistance to flow 
• Profunda collateral competition 
• Poor runoff 
• Distal embolization 
1.2 
DEVICE DESCRIPTION 
PQ Bypass designs and manufactures the PQ Bypass System which allows 
a percutaneous bypass procedure in the peripheral vasculature.  The PQ 
Bypass System is comprised of the TORUS Stent Graft System, the PQ 
Crossing Device and the PQ Snare.  
1.2.1. The PQ Crossing Device 
The PQ Crossing Device (Figure 1) is a spring-loaded delivery tool 
that utilizes a 0.025” Nitinol Needle with a 15 mm throw that 
exits approximately 45° to the PQ Crossing Device Shaft.  The PQ 

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Crossing Device 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 PQ Crossing Device also incorporates an 
intra-luminal Stabilizer and a Platinum-Iridium Marker Band used 
to support and direct needle deployment, respectively.  The PQ 
Crossing Device features are controlled using the Outer Handle 
and the Button on the PQ Crossing Device Handle. 
 
Figure 1: The PQ Crossing Device 
1.2.2. The PQ Snare 
The PQ Snare (Figure 2) 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 PQ 
Snare is 95 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). 
 
Figure 2: The PQ Snare 
                                                                   
Button 
Outer 
Handle 
Needle 
GW Port 
Inner Handle 
Shaft 
Stabilizer 
Needle 
Marker 
Band 
Rx GW 
Port 
Tip 
Proximal Handle 
Distal Handle 
Inner Sheath Tip 
Guidewire Port 
NiTi Cages 
Outer Sheath 
Distal RHV 
Inner Sheath 
Proximal RHV 
Cage Hypotube 
 Tip 

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Figure 3: The PQ Snare Cases Deployed 
1.2.3. TORUS Stent Graft  
The TORUS Stent Graft (Figure 4) is a flexible, self-expanding 
composite structure made of a NiTi-wire frame encapsulated in 
an expanded Polytetrafluorethylene (ePTFE) film. 
 
Figure 4: The TORUS Stent Graft 
1.2.4. TORUS Stent Graft Delivery System 
The TORUS Stent Graft Delivery System (Figure 5) is an 8Fr 
system.  It is 0.035” guidewire compatible and has a 135 cm 
working length.  The TORUS Stent Graft System is a familiar 
design which uses an outer sheath to maintain the TORUS Stent 
Graft in a compressed state.  The delivery system has radiopaque 
markers on both the proximal and distal ends of the TORUS Stent 
Graft landing zone (area where stent graft is located), as well as a 
marker band on the outer sheath to allow visualization of the 
sheath during deployment. 

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Figure 5: TORUS Stent Graft Delivery System 
1.3 
REGULATORY STATUS 
The PQ Bypass System received CE Mark in March 2017. 
1.4 
PROPOSED INTENDED USE 
The PQ Bypass System is intended to improve blood flow in patients with 
peripheral arterial disease in symptomatic femoropopliteal lesions due 
to chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, 
restenotic, or in-stent restenotic lesions; or total lesion lengths ≥24 cm 
that can include chronic total occlusions or a ≥70% lesion that includes 
de novo, restenotic or in-stent restenosis (complex TASC C). 
The PQ Crossing Device is intended to facilitate placement and 
positioning of guidewires in the distal peripheral vasculature. 
The PQ Snare is intended for retrieval and manipulation of atraumatic 
foreign bodies in the distal peripheral vasculature. 
1.5 
CE MARK STUDY – DETOUR I 
To evaluate the preliminary safety and effectiveness of the PQ Bypass 
System, the sponsor conducted the DETOUR I Clinical Trial (DETOUR I). 
This is a prospective, multi-center, single-arm, independently adjudicated 
study to assess the safety and effectiveness of the PQ Bypass System in 
patients with long-segment SFA disease. A total of 78 subjects were 
enrolled, and 77 subjects (81 limbs) were treated. Follow-up to one year 
has been completed, and follow-up to three years is ongoing. A brief 
update on the preliminary one-year results of DETOUR I is included below 
for context for the discussion of proposed modifications to the design of 

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the pivotal US IDE study. An interim study report will be included in the 
IDE supplement for this protocol modification. 
DETOUR I enrolled patients presenting with severe claudication, rest 
pain, or ischemic ulceration (Rutherford category 3-5). The primary 
efficacy endpoint was primary patency at six months, defined as freedom 
from clinically significant stenosis (≥ 50%) by duplex ultrasound (PSVR > 
2.5) within the stent graft or immediately above or below the treated 
segment and without clinically-driven reintervention within the stented 
segment. The primary safety endpoint was major adverse clinical events 
at one month, defined as the composite of death, target vessel 
revascularization, and major amputation of the target limb. Table 2 
below shows the lesion inclusion criteria and the actual lesion 
charactieristics enrolled in DETOUR I, and Table 3 below summarizes the 
demographics of the patients enrolled in the study. 

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Table 2: Baseline Lesion Characteristics in DETOUR I 
 
Inclusion Criteria 
Actual Lesions 
Enrolled* 
(n = 77/81) 
SFA lesion length, mm (Mean ± SD) 
Range (N) 
>100 mm 
371 mm ± 55 
222 mm – 472 
(81/81) 
Chronic total occlusion, (%, n/N) 
ANY 
96% (78/81) 
In Stent Restenosis (ISR), (%, n/N) 
ANY 
2.4% (2/81) 
Calcification, (%, n/N) 
Mild 
Moderate 
Severe 
ANY 
 
18.8% (15/80) 
13.8% (11/80) 
67.5% (54/80) 
Vessel Run-Off 
> 1 PATENT TIBIAL 
VESSEL 
 
1 
7.7% (6/78) 
2 
29.5% (23/78) 
3 
62.8% (49/78) 
*Analysis based on 81 treated lesions; where sample size is less than 81, 
complete lesion data were not available. 
 
Table 3: Patient Demographics and Clinical Characteristics in DETOUR I 
Clinical Characteristics 
N=77 Subjects 
Male (%, n/N) 
83.1% (64/77) 
Age (Years) (mean ± SD) 
64.1  7.2 
Diabetes Mellitus (%, n/N) 
24.7% (19/77) 
Hypertension (%, n/N) 
83.1% (64/77) 
Hypercholesterolemia (%, n/N) 
39.0% (30/77) 
History of CAD or MI (%, n/N) 
42.9% (33/77) 
History of Smoking (%, n/N) 
87.0% (67/77) 
Previous Peripheral Intervention (%, n/N) 
29.9% (23/77) 
ABI (mean ± SD) 
0.64  0.17 (81 Limbs) 
Rutherford Category 3 
93.0% (75/81 Limbs) 
Rutherford Category 4-5 
7.0% (6/81 Limbs) 

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CLINICAL ENDPOINTS 
The primary safety endpoint was major adverse events (MAEs) at 30 
days, defined as the composite of death, target vessel revascularization, 
and target limb amputation. At 30 days, the MAE rate was 6.5% (5/77), 
consisting of five target vessel revascularizations (TVR). At one year, the 
MAE rate was 26%, consisting of 19 TVR and one death (due to ischemic 
stroke at 114 days post-procedure). Two subjects had deep vein 
thrombosis (DVT). One DVT was secondary to trauma in a patient who 
received a diagnosis of vasculitis following enrollment. The second DVT 
was secondary to right inguinal hernia repair, and the subject also 
stopped following the DAPT regimine. Both were treated with medical 
therapy and resolved without sequelae. Table 4 summarizes the safety 
outcomes for the DETOUR I Clinical Trial. 

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Table 4: DETOUR I Safety Outcomes 
Safety Outcomes 
30 Days 
12 Months 
 
Subjects 
Limbs 
Subjects 
Limbs 
Death  
0% (77/77) n/a 
1.2% (1/77) n/a 
TVR 
6.5% 
(5/77) 
6.2% (5/81) 25.0% 
(19/76) 
23.8% 
(19/80) 
Major Amputation 
of Ipsilateral Limb 
0% (0/77) 
0% (0/81) 
0% (0/76) 
0% (0/80) 
MAE 
(Death, TVR, 
Amputation) 
6.5% 
(5/77) 
6.2% (5/81) 26.0% 
(20/77) 
24.7% 
(20/81) 
Deep Vein 
Thrombosis  
1.3% 
(1/77) 
1.2% (1/81) 2.6% (2/76) 2.5% (2/80) 
Pulmonary 
Embolism 
0.0% 
(0/77) 
0.0% (0/81) 0.0% (0/76) 0.0% (0/81) 
Bleeding event 
requiring 
transfusion > 2 
units of packed red 
blood cells. 
0% (0/77) 
0% (0/81) 
0% (0/76) 
0% (0/80) 
Bleeding event 
requiring any 
transfusion 
1.3% 
(1/77) 
1.2% (1/81) 1.2% (1/76) 1.3% (1/80) 
 
Primary patency was 93.8% (76/81) and 73.8% (59/80) at 30 days and 
one year, respectively. At one year, an additional five subjects remained 
patent after reintervention for non-occlusive disease, and nine more had 
successfully revascularized graft occlusions, for assisted and secondary 
patency rates of 80.0% and 93.8%, respectively. 
In summary, this initial experience demonstrates that the endovascular 
bypass with the PQ Bypass System could be accomplished with 98.8% 
technical success (defined as the successful delivery of the investigational 
device to the identified area and removal of the delivery system) in 
extremely long (> 200 mm), calcified, primarily CTO lesions, with a 93.5% 

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freedom from MAE to 30 days (five early revascularizations). Primary 
patency was excellent at 30 days, and 74% of subjects remained patent at 
one year. This primary patency rate was achieved in patients with a mean 
lesion length of 371 mm. 
1.6 
RISKS AND BENEFITS 
1.6.1. Risks 
There are standard risks associated with any interventional 
procedure or stent graft placement as well as risks specific to the 
PQ Bypass System 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 component manufactured by PQ 
Bypass and their use in the PQ Bypass System procedure. 
Possible risks related to the PQ Crossing Device and the PQ Snare 
include, but are not limited to, the following: access vessel 
(arterial/venous) occlusion, amputation, bleeding complications; 
death, device malfunction/failure, embolism (peripheral or 
pulmonary), fever in absence of infection, hemorrhage or 
hematoma, infection local or systemic including bacteremia or 
septicemia, myocardial infarction, pain (insertion site, leg and/or 
foot), shock, stroke or transient ischemic attack, thrombosis, vessel 
wall trauma (dissection, perforation or rupture), vessel spasm, 
and/or venous flow disruption (deep vein thrombosis, phlebitis, leg 
swelling and/or development of varicose veins).   
Possible risks related to the TORUS Stent Graft System include, but 
are not limited to, the following: access vessel (arterial/venous) 
occlusion, amputation, aneurysm or pseudoaneurysm, 
arteriovenous fistula, bleeding complications, death, device or 
deployment malfunction/failure, embolism (peripheral or 
pulmonary), fever in absence of infection, hemorrhage or 
hematoma, infection local or systemic including bacteremia or 
septicemia, malapposition or migration, malposition, myocardial 
infarction, pain (insertion site, leg and/or foot), side branch 
occlusion stroke or transient ischemic attack, thrombosis, vessel 
wall trauma (dissection, perforation or rupture), vessel spasm, 
venous flow disruption (deep vein thrombosis, phlebitis, leg 
swelling and/or development of varicose veins), and/or worsening 
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Additionally, subjects will be exposed to risks associated with 
conscious sedation, use of contrast and procedural medications.  
Subjects will be asked to take anti-platelet medication for this 
study, such as aspirin for life and Plavix (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 that 
cannot be medically managed otherwise (e.g. 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. 
1.6.2. 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 System may 
allow physicians to treat challenging lesions in the femoral-
popliteal artery percutaneously, thereby avoiding the risks and 
morbidity of more invasive procedures such as surgical bypass or 
amputation. 
2.0 
TRIAL OBJECTIVES 
The objectives of the IDE Study are to evaluate the safety and effectiveness of 
the PQ Bypass System to access, deliver guidewires and implant stent grafts for a 
percutaneous fem-pop bypass.  The safety and effectiveness of the PQ Bypass 
System will be established by comparing the primary safety and effectiveness 
endpoints in the IDE Study to safety and effectiveness Performance Goals (PG).   
• 
The primary safety endpoint will compare Major Adverse Event (MAE) at 30 
days for the PQ Bypass System Group to a safety Performance Goal (PG) 

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derived from literature, including an aggregate of published trial data and 
the Summary of Safety and Effectiveness Data (SSED) of the PMAs of 
approved devices. 
• 
The primary effectiveness endpoint will compare primary patency at 12 
months of the PQ Bypass System Group to an effectiveness PG derived from 
literature, including an aggregate of published trial data and the Summary 
of Safety and Effectiveness Data (SSED) of the PMAs of approved devices. 
3.0 
SELECTION AND WITHDRAWAL OF SUBJECTS 
3.1 
INCLUSION CRITERIA 
All subjects are required to meet the following inclusion criteria in order 
to be considered eligible for participation in this trial: 
General Inclusion Criteria 
1. Age > 18 and ≤ 90 years of age. 
2. Willing and able to provide informed consent.  
3. Subject is willing to undergo all follow-up assessments according to 
the specified schedule over 36 months. 
Clinical Inclusion Criteria 
4. Chronic, symptomatic lower limb ischemia defined as Rutherford 
clinical categories 3, 4, or 5. 
5. Venous Clinical Severity Score < 3. 
6. Subject is a suitable candidate for angiography and endovascular 
intervention and, if required, is eligible for standard surgical repair. 
Angiographic Inclusion Criteria 
7. Symptomatic femoropopliteal chronic total occlusions ≥ 20 cm (TASC 
D) that can include de novo, restenotic, or in-stent restenotic lesions; 
or 
Symptomatic femoropopliteal lesions ≥ 24 cm (total lesion length) 
that can include a chronic total occlusion or a ≥70% lesion that 
includes de novo, restenotic or in-stent restenosis (complex TASC C), 
by investigator visual assessment. 
8. Reference vessel diameter ≥ 4.5 and ≤ 6.7 mm, by investigator visual 
assessment. 
9. Subject has a patent popliteal artery (<50% stenosis) distal to the 
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10. Able to successfully access the SFA origin for entry of the crossing 
device. 
11. At least one patent infrapopliteal vessel (<50% stenosis) with run-off 
to the ankle or foot. 
12. A significant stenosis (≥ 50%) or occlusion of an ipsilateral, inflow 
artery (e.g. aortoiliac, common femoral) must be successfully treated 
(use of investigational treatment prohibited) prior to treatment of the 
target lesion. Successful treatment is defined as no complications and 
less than 30% residual stenosis following intervention. 
3.2 
EXCLUSION CRITERIA 
Subjects will be excluded from participating in this trial if they meet any 
of the following exclusion criteria: 
General Exclusion Criteria 
1. Participating in another investigational clinical study. 
2. Anticipated life expectancy less than 1 year or medical comorbid 
condition(s) that could limit the subject’s ability to comply with the 
requirements of the trial. 
3. Subject has other medical, social or psychological problems that, in the 
opinion of the investigator, preclude them from receiving this 
treatment, and the procedures and evaluations pre- and post-
treatment. 
Clinical Exclusion Criteria 
4. History of deep vein thrombosis on either limb. 
5. Thrombophlebitis, within the previous 30 days. 
6. Planned  amputation of the target limb, including minor amputation. 
7. Prior  distal amputation (above the transmetatarsal) of the target limb. 
8. Known or suspected active infection at the time of the procedure (e.g., 
WIfI foot infection grade 3: Severe infection. Local infection with 
systemic inflammatory response syndrome [SIRS]). 
9. Rutherford clinical category 0, 1, 2 or 6. 
10. Has acute or chronic renal disease with GFR ≤ 30 ml/min per 1.73 m2 
and/or elevated serum creatinine >2.5mg/dL (220µmol/L) or on 
dialysis. 

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11. Known hypersensitivity/allergy to the investigational devices and/or 
required pharmacotherapy that cannot be safely managed. 
12. Morbid obesity that does not allow for safe vascular access or imaging. 
13. Subject has a known coagulopathy or has bleeding diatheses, 
thrombocytopenia with platelet count less than 100,000/microliter or 
INR > 1.8. 
14. Requires coronary or peripheral procedure within 30 days prior to or 
planned within 30 days post treatment of the target lesion. 
15. Has a known history of intracranial bleeding or aneurysm, myocardial 
infarction or stroke within the last 3 months. 
16. Subject is pregnant or breast-feeding. 
Angiographic Exclusion Criteria 
17. Stent within 3 cm of SFA ostium. 
18. Previous bypass surgery on the target limb. 
19. Subject has significant disease or obstruction (≥50%) of the inflow tract 
that has not been successfully treated at the time of the index 
procedure (success measured as ≤30% residual stenosis, without 
complication) 
20. Presence of aneurysm or acute thrombus in the target limb. 
21. Thrombolysis of the target vessel within 72 hours prior to the index 
procedure, where complete resolution of the thrombus was not 
achieved. 

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3.3 
WITHDRAWAL OF SUBJECTS 
Each subject may voluntarily withdraw his/her participation from the study 
at any time without jeopardy or prejudice. If a subject prematurely 
terminates from the study, the reason for study termination will be 
recorded and the results will be tabulated by number and percent for each 
category. If termination is a result of an adverse event or death, an 
Adverse Event Form will also be completed. Subjects who withdraw 
consent after treatment will have their data evaluated until the time of 
their withdrawal. 
The Investigator should follow all unresolved serious adverse events until 
the events are resolved, the subject is lost to follow-up, the subject has 
withdrawn consent, the subject completes the study, or the adverse event 
is otherwise explained. 
All reasonable efforts will be made to obtain complete data for all 
subjects; however, missing observations will occur due to loss to follow-
up, withdrawal, or non-adherence with required assessments. Three 
attempts shall be made to contact subjects who do not return for study 
follow-up visits. The final attempt shall include a certified letter to the 
subject regarding study participation. If these subjects cannot be locatedat 
the final scheduled visit, they will be considered lost to follow-up. If they 
are contacted but refuse to return for visits, they will be considered 
withdrawals. Subjects shall be encouraged to complete a final study exit 
visit at the time of withdrawal to assess for safety. Data collected up to the 
time of loss to follow-up or withdrawal will be maintained in the study 
database and used for analysis purposes, as appropriate. These subjects 
will not be replaced. 
4.0 
TRIAL DESIGN 
4.1 
DESCRIPTION OF TRIAL DESIGN 
Prospective, single-arm, multi-center, international clinical investigation to 
evaluate the safety and effectiveness of the PQ Bypass System to access, 
deliver guidewires, and implant stent grafts for a percutaneous 
femoropopliteal (fem-pop) bypass. 
4.2 
TRIAL ENDPOINTS 
4.2.1 Primary Effectiveness Endpoint 
The absence of clinically-driven target lesion revascularization and 
absence of recurrent target lesion diameter stenosis >50% by 
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>2.5) or invasive angiography) with the stent or immediately 1 cm 
above or below the treated segment.  When both modalities are 
available, angiography takes precedence..  
4.2.2 Primary Safety Endpoint 
Freedom from a major adverse event (MAE) at 30 days post-
procedure defined as any occurrence of the following events: 
Death, Clinically-Driven Target Lesion Revascularization (CD-TLR), 
Amputation of the Treated Limb, Symptomatic Deep Vein 
Thrombosis (DVT), Pulmonary Embolism, or procedure-related 
bleeding requiring any transfusion of packed red blood cells or 
surgery. 
4.2.3 Secondary Endpoints  
1. Major Adverse Events (MAE) at 6, 12, 24 and 36 months 
2. Major Adverse Limb Event (MALE) defined as above-ankle 
amputation or major reintervention including placement of a 
new bypass graft, interposition graft, thrombectomy, or 
thrombolysis 
3. Major bleeding is defined as any bleeding event requiring 
transfusion of ≥2 units packed red blood cells (PRBC) or 
surgical repair through 30 days 
4. Symptomatic Deep Vein Thrombosis (DVT) on ipsilateral limb 
at 30 days and 6, 12, 24 and 36 months 
5. Pulmonary embolism at 30 days and 6, 12, 24 and 36 months  
6. Perioperative myocardial infarctions through 30 days 
7. Hematoma ≥ 8 cm related to the device or procedure through 
30 days 
8. The combined rate of death, target lesion revascularization 
(TLR), index limb amputation, and an increase in Rutherford 
ClinicalBecker Classification by 2 classes (comparing pre- to 
post-procedural assessments) at 30 days and 6, 12, 24 and 36 
months  
9. Stent graft separation and migration identified via ultrasound 
imaging at 30 days and 6, 12, 24 and 36 months 
10. Stent graft separation and migration identified via X-ray at 12 
months 
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12. Technical Success defined as successful delivery of the 
investigational devices to the identified area and removal of 
delivery system   
13. 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 
14. Clinical Success defined as limb ischemia improvement as 
assessed by Rutherford Clinical Classification  (improvement in 
scale by ≥1) at 30 days and 6, 12, 24 and 36 months 
15. Limb ischemia by Rutherford Clinical - Classification through 
follow-up at 30 days and 6, 12, 24 and 36 months 
16. Primary Patency at 30 days and 6, 24 and 36 months 
17. 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 at 30 days and 6, 12, 24 and 36 
months 
18. 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 at 30 days and 6, 12, 24 and 36 months 
19. Target Vessel Revascularization defined as any repeat 
percutaneous intervention or surgical bypass of any segment 
of the target vessel at 30 days, 6, 12, 24 and 36 months 
20. Ankle-Brachial Index (ABI) or Toe Brachial Index (TBI) of both 
the index limb and contralateral limb at 30 days and 6, 12, 24 
and 36 months 
21. Number of major index limb amputations at 30 days and 6, 12, 
24 and 36 months  
22. Major procedure-related infections within 30 days 
23. Length of post-procedure hospital stay 
24. Length of ICU stay 
25. Hospital re-admissions through 30 days 
26. Change from baseline in VascuQol QOL Score at 30 days and 
12 months 

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27. Change from baseline in EQ-5D-5L QOL Score at 30 days and 
12 months 
28. Change from baseline in Duplex Venous Observation Scale at 
30 days and 6, 12, 24 and 36 months 
29. Change from baseline in Villalta and Venous Clinical Severity 
(VCSS) Scales at 30 days and 6, 12, 24 and 36 months 
30. SF-12 Score at Baseline, 30 days and 12 months 
4.2.4 Health Economics Analysis 
Health care costs and incremental cost-effectiveness for the study 
population will be assessed throughout through 12 months.  The 
following data elements will be collected for each study subject.  
1. Quality-of-life outcome measures will be collected at Baseline, 
30 days and  12 months from date of enrollment utilizing the 
EQ-5D-5L questionnaire 
2. Procedure and follow-up cost data, including 
rehospitalizations, will be collected through 12 months from 
the date of enrollment. 
3. Length of post-procedure hospital stay 
4. Length of ICU stay 
Follow-up resource utilization and cost data will be collected 
through 12 months from the date of enrollment.  Data to be 
collected may include, but are not limited to copies of the 
subjects’ hospital bills (UB04) and/or itemized hospital bills.  The 
following personal health information from the UB04 may be 
collected but not limited to: 
1. Subject’s hospital admission date 
2. Number of devices used 
3. Subject’s hospital discharge date  
4. Subject’s procedure date 
5. ICD-10 diagnosis and procedure codes, HCPCS and CPT codes 
6. Itemized and total charges for hospitalizations 
7. Number and duration of admissions to rehabilitation 
hospitals, nursing homes and other chronic care facilities (and 
whether the admission was related to PAD and its treatment) 

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8. Self-reported measures of outpatient medical resource 
utilization over the course of the follow-up period 
4.2.5 Subgroup Analysis 
A multivariate logistic regression model will be fit with 
independent variables (unique for safety and effectiveness 
analyses) for the subgroup levels as well as the baseline 
characteristics.  Separate baseline characteristics will be 
developed for safety and effectiveness analyses.  
With respect to the primary safety endpoint, the following 
baseline characteristics will be compared across the subgroups: 
• Age (years) 
• Gender 
• History of smoking  
• History of diabetes 
• Previous peripheral interventions 
• Renal insufficiency  
• Congestive heart failure 
• Lesion length (cm) 
• TASC II classification 
• Rutherford classification 
• Number of run-off vessels 
With respect to the primary effectiveness endpoint, the following 
baseline characteristics will be compared across the subgroups: 
• Gender 
• History of smoking  
• History of diabetes 
• Previous peripheral interventions 
• Lesion length (cm) 
• TASC II classification 
• Rutherford clinical classification 
• Number of run-off vessels 

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Any differences that persist after this adjustment will require 
further investigation to understand the underlying cause for the 
observed differences. 
4.2.6 Additional Analyses 
1. 6 Minute Walk Test at Baseline, 30 days and 12 months 
2. Comparison the Open Bypass Primary Patency (Flow vs. No-
Flow) at 12 months 
4.3 
SAMPLE SIZE 
Up to 202 subjects, excluding elective roll-ins, with atherosclerotic lesions 
of the native superficial femoral artery (SFA) or the superficial femoral and 
proximal popliteal arteries, suitable for treatment with PQ Bypass System 
will be enrolled.   
At least 50% of subjects will be enrolled in the U.S. and no single site will 
enroll greater than 20% of all subjects. 
The first two Subjects enrolled and treated at each site may be considered 
roll-in subjects.  Roll-in subjects will be pre-specified.  
 
4.4 
INVESTIGATIONAL SITES 
The clinical trial will be conducted at up to 40 clinical sites in the United 
States and up to 10 sites in Europe. 
A single investigational site shall not enroll more that 20% of the total 
planned trial population (i.e., 42 subjects) without the prior written 
approval of the Sponsor. 
4.5 
DURATION OF SUBJECT PARTICIPATION 
Subjects enrolled in the trial will participate for approximately 36 months 
(3 years).  
4.6 
EARLY STUDY TERMINATION 
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 

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• A decision on the part of PQ Bypass to suspend or discontinue 
development of the device 
4.7 
WRITTEN INFORMED CONSENT 
Subjects who meet general and clincal entry criteria will be asked to sign 
the study specific Ethics Committee (EC) or Institutional Review Board 
(IRB) approved Informed Consent Form(s) (Appendix I) 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.   
4.8 
ENROLLMENT 
According to ISO 14155:2011, enrollment in the study occurs at the time of 
informed consent; however, for the purposes of this study, only subjects 
who are consented and meet all the study inclusion criteria and none of 
the study exclusion criteria, venous and arterial access has been achived 
and study device advanced beyond the sheath will be considered enrolled 
into the study. Therefore, the enrollment date (Day 0) will be the date of 
the study index procedure; the enrollment date will not be the date of 
informed consent for this study. Subjects in whom the PQ Bypass System is 
inserted into the vascular and/or the procedure was aborted without 
treatment with the device shall be followed through discharge for safety 
only and allowed to exit the study.   
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. 
4.9 
STUDY PROCEDURES 
Subjects will return to the study center at 1 month (30 days ±7 days), 6 
months (180 days ±30 days), 12 months (360 days ±30 days), 24 months 
(720 days ±60 days), and 36 months (1080 days ±60 days) following the 
procedure for a follow-up evaluation.  The subject will undergo lower-
extremity arterial and venous duplex ultrasounds, venous health 
questionnaires, QOL surveys, walk test, and examined for any post-
procedural complications or adverse events. 
4.9.1 Initial Eligibility 
After subjects have signed an informed consent form and before 
the scheduled interventional procedure, subjects will undergo an 

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initial eligibility evaluation by the investigator.  Medical history 
within the previous 30 days and imaging performed within the 
previous 180 days may be used for this initial eligibility 
evaluation.  The evaluation may consist of the following: 
• Pre-procedural  imaging (CT, MRA, Angio, etc.) 
• Pre-procedural venous ultrasound 
• Review of inclusion/exclusion criteria 
Subject eligibility and pre-procedure imaging studies will be 
reviewed to assess subject eligibility.  This process may be done in 
collaboration with a screening committee, clinical site 
investigators, core lab assessment, medical advisory committee, 
etc. in an effort to assist the sites in eligibility requirements.   
4.9.2 Baseline Evaluation 
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 and surgical history review, including peripheral 
vascular history 
• Rutherford clinical category  
• Venous Clinical Severity Score 
• Villalta Scale  
• Routine Laboratory Tests (CBC and Chem-7; urine pregnancy 
test, if applicable) 
• eGFR  
• Ankle Brachial Index or Toe-Brachial Index 
• EQ-5D-5L QOL survey 
• VascuQOL survey 
• SF-12 
• 6-Minute Walk Test (subgroup of subjects only) 
• Review of inclusion/exclusion criteria 
Note:  The 6-Minute Walk Test is not routinely performed at all 
clinical sites; therefore, select sites shall complete a 6MWT on 
select subjects as agreed upon.  This will therefore result in a sub-
group of clinical sites and subjects and not be studywide.   
 
 

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4.9.3 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 PQ Crossing Device and the PQ 
Snare 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.  The 
number of deployment attempts for guidewire placement access 
at each anastomosis will be recorded. 
4.9.4 TORUS Stent Graft Placement 
TORUS Stent Grafts of appropriate dimension are selected by 
investigators visual estimates of arterial diameter. SGs are then 
deployed in series, starting distally, until the bypass is complete.  
After placement, the Investigator uses a standard balloon 
dilatation catheter to complete stent apposition, ensuring that the 
balloon is only inflated within the TORUS Stent Graft’s lumen. 
4.9.5 Anticoagulation and Dual Antiplatelet Therapy  
Effective anticoagulation therapy should be maintained throughout 
the procedure with heparin (per hospital or institutional standards, 
recommending a minimum of ACT >250) or a clinically acceptable 
alternative of the treating physician’s choice.  Subjects must be 
treated with antiplatelet and/or anticoagulation for a minimum of 
three years. Table 5 shows the recommendation for administration 
of these medications, but the final decision is up to the operator 
and may include other antiplatelet or anticoagulation agents not 
identified. 
 
 
Table 5: Administration of Anticoagulations and Dual Antiplatelet Medications 
Medication 
Peri-Procedure 
(± 24 hours of Index 
Procedure) 
Intra-Procedure 
Post-Procedure 

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Aspirin 
Minimum loading dose of 
75 mg required, if not on 
long-term aspirin therapy 
N/A 
A minimum of 75 mg per 
day indefinitely 
Clopidogrel* 
(or similar 
antiplatelet 
agent or 
alternative 
agent per 
investigator 
discretion) 
Minimum loading dose of 
300-600 mg required, if 
not on long-term 
clopidogrel therapy 
N/A 
Clopidogrel 75 mg per day 
for a minimum of 3 years 
(or per prescribing dose if 
other similar antiplatelet 
agent or alternative agent 
per investigator discretion) 
Heparin / 
Bivalirudin 
N/A 
Maintain 
anticoagulation per 
hospital / institution 
standard of care 
(minimum of ACT >250 
sec recommended) 
N/A 
*  For patients requiring anticoagulation therapy (NOAC or OAC), antiplatelet monotherapy with either aspirin or 
clopidogrel for 3 years, followed by aspirin therapy or other anti-coagulant indefinitely is recommended, using 
investigator discretion for the best interest and safety of the subject.   
 
 
4.9.6 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 characteristics (lesion length and TASC II classification) 
• Procedure start and finish times  
• Access sites used 
• Number of attempts to create each anastomosis 
• Complications or adverse events 
• Review of angiographic inclusion/exclusion criteria 
 
 
 
4.9.7 Discharge Evaluation 
The discharge evaluation will consist of: 

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• Physical examination and health status 
• Complications or adverse events 
• Anticoagulations and Dual Antiplatelet Medications 
4.9.8  Follow-Up Evaluations 
Subjects will return to the study center for follow-up evaluations 
at 1 month (30 days ±7 days), 6 months (180 days ±30 days), 12 
months (360 days ±30days), 24 months (720 days ±60 days), and 
36 months (1080 days ±60 days) post-index procedure. Follow-up 
evaluations will include: 
• Physical examination and health status 
• Rutherford score  
• Ankle-Brachial Index/Toe-Brachial Index  
• Venous Clinical Severity Score 
• Villalta Scale 
• Arterial and Venous duplex-ultrasound assessment 
• EQ-5D-5L QOL Survey (Baseline, 1 and 12 months) 
• VascuQOL Survery (Baseline, 1 and 12 months) 
• SF-12 (Baseline, 1 and 12 months) 
• 6-minute Walk Test (Baseline, 1 and 12 months,sub-group of 
subjects only) 
• Stent Graft X-ray (12 months) 
• Complications and adverse events 
• Anticoagulations and Dual Antiplatelet Medications  
 
4.9.9 Subject Lost to Follow-Up 
A subject will be considered lost to follow-up and terminated from 
the study when all of the following criteria have been met: 
• On the final study visit with supporting documentation of 
three unsuccessful attempts on three different days over a 
period of three (3) months at both study visits 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. 
5.0 
ASSESSMENT OF EFFICACY 

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5.1 
PRIMARY EFFECTIVENESS ENDPOINT 
The primary effectiveness endpoint is defined as primary patency at 12 
months as evidenced by a peak systolic velocity ratio (PSVR) ≤2.5 from 
DUS and no clinically-driven re-intervention within the stented segment. 
The primary effectiveness endpoint hypotheses are:      
• H0:  12-month success rate of the PQ Bypass System ≤60.4.0% 
• HA: 12-month success rate of the PQ Bypass System >60.4.0% 
Based on a PG of 60.4%, a sample size of 202 with 181 subjects with 
evaluable data at 12 months would provide 91% power to test the 
primary effective hypothesis at the one-sided alpha level of 0.025, if the 
PQ Bypass Stent Graft success rate is at least 72%.  The Exact Test 
Method and commercial software PASS14 was used to determine the 
sample size.   
In order to ensure sufficient subjects are available at 12 months for 
assessment of the primary effectiveness endpoint (i.e., to account for 
missing data), an additional 21 subjects (approximately 10% estimated 
attrition rate) may be enrolled, making the total study sample size equal 
to 202 subjects.   
To meet the primary effectiveness endpoint of the IDE Study with a 
sample size of 202 enrolled and 191 evaluable subjects with 12 month 
primary patency data, at least 124 subjects (≥68.1%) must experience 12-
month primary patency (calculated using the exact confidence interval). 
6.0 
ASSESSMENT OF SAFETY 
6.1 
PRIMARY SAFETY ENDPOINT 
The primary safety endpoint of the PQ Bypass Detour II IDE Study 
Freedom from a major adverse event (MAE) at 30 days post-procedure 
defined as any occurrence of the following events: Death, Clinically-
Driven Target Lesion Revascularization (CD-TLR), Amputation of the 
Treated Limb, Symptomatic Deep Vein Thrombosis (DVT), Pulmonary 
Embolism, or procedure-related bleeding requiring any transfusion of 
packed red blood cells or surgery. 
7.0 
STATISTICS 
7.1 
STATISTICAL HYPOTHESES AND SAMPLE SIZE JUSTIFICATION 
This is a prospective, single-arm, multi-center, international clinical 
investigation to evaluate the safety and effectiveness of the PQ Bypass 
System, delivery guidewires, and implant stent grafts for percutaneous 

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femoropoliteal bypass compared to Performance Goals (PG). There are 
two hypotheses for the study. One is for the primary effectiveness 
endpoint – primary patency within 12 months, and one is for the primary 
safety endpoint – freedom from major adverse events (MAE) through 30 
days. 
7.1.1. Primary Effectiveness 
The primary effectiveness endpoint is defined as primary patency 
at 12 months as evidenced by a peak systolic velocity ratio (PSVR) 
≤2.5 from DUS and no clinically-driven re-intervention within the 
stented segment. 
 
The primary effectiveness endpoint hypotheses are:      
• H0:  12-month success rate of the PQ Bypass System ≤60.4% 
• HA: 12-month success rate of the PQ Bypass System >60.4% 
 
Based on a PG of 60.4%, a sample size of 202 with 181 subjects 
having evaluable data at 12 months would provide 91% power to 
test the primary effective hypothesis at the one-sided alpha level 
of 0.025, if the “true” PQ Bypass Stent Graft success rate is at 
least 72%.  The Exact Test Method and commercial software 
PASS14 was used to determine the sample size.   
 
In order to ensure sufficient subjects are available at 12 months 
for assessment of the primary effectiveness endpoint (i.e., to 
account for missing data), an additional 21 subjects 
(approximately 10% estimated attrition rate) may be enrolled, 
making the total study sample size equal to 202 TASC II D and 
complex TASC C subjects.   
 
To meet the primary effectiveness endpoint of the IDE Study with 
a sample size of 202 enrolled and 181 evaluable subjects with 12 
month primary patency data, at least 124 subjects (≥68.1%) must 
experience 12-month primary patency (calculated using the exact 
confidence interval). 
7.1.2. Primary Safety 
The primary safety endpoint of the PQ Bypass Detour II IDE Study 
is the freedom from MAE rate at 30 days following stent graft 
implantation, and includes:  
 

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• Death 
• Target lesion revascularization (TLR) 
• Amputation of the index limb 
• Symptomatic deep vein thrombosis (DVT) 
• Pulmonary embolism (PE)  
• Procedure related bleeding requiring any transfusion of 
packed red blood cells or surgery 
 
The primary safety endpoint hypotheses are: 
 
• H0: 30-day Freedom from MAE rate of the PQ Bypass System 
≤84% 
• HA: 30-day Freedom from MAE rate of the PQ Bypass System 
>84% 
 
The rate of freedom from 30-day MAE for the PQ Bypass System 
is expected to be no less than 92%.  Based on a PG of 84% and an 
estimated 30-day freedom from MAE rate of 92% for the PQ 
Bypass System, a sample size of 169 evaluable subjects provides 
88% power to test the primary safety hypothesis at the one-sided 
alpha level of 0.025. The Exact Test Method and Commercial 
software PASS14 was used to determine the sample size.  The 
final sample size is based on the number required to test the 
primary effectiveness hypothesis (N=181 including attrition).  The 
primary analysis population will include 202 TASC II D and 
complex TASC C subjects. 
 
To meet the primary safety endpoint of the IDE Study with a 
sample size of 181 evaluable subjects (the actual number of 
subjects who are free from MAEs at 30 days MAE can be no less 
than 163 subjects (≥89.6%). 
7.2 
 ANALYSIS POPULATIONS 
Analysis populations include the Intention to Treat (ITT), Modified 
Intention to Treat (MITT) and Per Protocol Cohorts. The primary analysis 
will be on the TASC II D and complex C population excluding roll-ins.  
 
7.2.1. Roll-in Cohort 
The first two subjects at each U.S. site may be considered a roll-in 
subject.  Roll-in subject will be pre-identified.  Baseline 
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will be reported separately and be purely descriptive.  The roll-in 
cohort will be excluded from hypothesis testing and from the ITT 
and MITT populations. 
7.2.2. Intention to Treat (ITT) 
The ITT Cohort includes all subjects enrolled in the IDE Study.  The 
ITT Cohort will be the primary analysis population to determine if 
the primary safety endpoint was met in the study.  
7.2.3. Modified Intention to Treat (MITT) 
The MITT Cohort includes only those subjects/lesions where a PQ 
Bypass System Stent Graft was implanted.  The MITT cohort is a 
subset of the ITT Cohort.  The MITT Cohort will be the primary 
analysis population to determine if the primary effectiveness 
endpoint was met in the study. 
7.2.4. Per Protocol 
The per protocol population is a subset of the MITT group which 
will exclude all subjects with major protocol deviations (e.g., 
violations of eligibility criteria, or DAPT compliance). 
 
7.3 GENERAL STATISTICAL CONSIDERATIONS 
Demographic, baseline clinical and disease characteristics and procedural results 
will be summarized in tables for both ITT and MITT populations.  For continuous 
variables, the summary will include the number, mean, median, standard 
deviation, minimum and maximum.  Summaries for categorical variables will 
include the number and percent of subjects in each category.  Confidence 
intervals may be presented, where appropriate, using the t-distribution for 
continuous data and the Exact binomial method for categorical variables. 
Statistical analyses will be performed using SAS for Windows version 9.4 or 
higher.   
 
DATA CONSIDERATIONS 
7.3.1. Missing Data 
Subjects free from clinically-driven target lesion revascularization  
within the stented segment but do not have sufficient follow-up 
to assess the primary effectiveness endpoint will be treated as 
having missing data for the primary effectiveness endpoint. To 
further evaluate the impact of missing data on the primary 

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effectiveness endpoint, Kaplan-Meier methods, will also be used 
to estimate the 12-month primary patency rate.  
For the primary safety endpoint analysis, the denominator for 
each parameter in the safety measures will be the number of 
subjects who had sufficient follow up (at least 23 days for 30-day 
visit) plus any subjects who had an event prior to the milestone 
visit. 
All subjects will be accounted for in the study report, including 
the reasons for any subjects exiting the study early.  
Every effort will be made to collect all data points contributing to 
the primary effectiveness endpoint in the study. The sponsor 
attempts to minimize the amount of missing data by appropriate 
management of the prospective clinical trial, proper screening of 
study subjects, and training of participating investigators, 
monitors and study coordinators. In order to further assess the 
potential impact of missing data on the primary effectiveness 
endpoint analyses, the following sensitivity analyses will be 
performed: 
• Worst-Case Scenario: Each missing value for the primary 
effectiveness endpoint will be treated as a failure. If this still 
results in rejection of the null hypothesis then no further 
missing data imputation analyses will be performed for the 
endpoint. 
• If the conclusion is not upheld with the worst-case scenario 
approach, then the multiple imputation method will be used. 
A logistic regression model will be used and fifteen imputed 
datasets will be generated. 
• Additionally a tipping point analysis will be performed. The 
proportion of missing values assigned the status of ‘failure’ 
will be sequentially increased to identify the point at which 
the study conclusions change (i.e., the null hypothesis is no 
longer rejected). 
7.3.2. Data Pooling 
Poolability analyses will be performed on primary safety and 
effectiveness endpoint results to determine if subjects enrolled in 
different regions (U.S. vs. Outside the US, (OUS)) and subjects at 
different sites can be pooled.   

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7.3.2.1.  Poolability by Region 
To determine if region (U.S. vs. OUS) has an effect on 
primary safety and effectiveness outcomes, a poolability 
by region analysis will be performed which compares the 
primary effectiveness and primary safety endpoint results 
between subjects enrolled in the U.S. vs OUS.  
Comparisons will be made using Fisher’s Exact Test and 
poolability will be assessed at the 0.15 significance level.  If 
the p-value is non-significant (p≥0.15) then the regions will 
be considered poolable.  If the differences are significant 
(p<0.15), then baseline characteristics will be compared 
between the U.S. and OUS regions.  Since this is a single 
arm study, differences in outcomes could be due to 
differences in baseline characteristics by region or due to 
difference in device performance.  To better understand 
the underlying cause of apparent differences, a model will 
be fit that includes region, as well as any baseline 
characteristics that differ significantly by region. 
7.3.2.2.  Site by Site Poolability 
To determine if individual sites have an impact on primary 
safety and effectiveness endpoint results, a site-by-site 
poolability analysis will be performed.  Comparison will be 
made using Fisher’s Exact Test and poolability will be 
assessed at the 0.15 significance level.  If the p-value is 
non-significant (p>0.15) then site results will be considered 
poolable.  If the p-value is significant (p≤0.15) then the 
effect on the site by site comparison in the presence of 
any baseline characteristics found to be out of balance 
across sites will be analyzed. Sites having fewer than 5 
subjects will be combined into low enrolling pseudo site 
pool group(s). 
7.4 
EFFICACY ANALYSES 
7.4.1. Primary Effectiveness Analysis 
The MITT cohort will be used to evaluate the primary 
effectiveness endpoint.  All subjects in the MITT population that 
have a clinically-driven re-intervention within the stented 
segment that occurs within 360 days of the index procedure will 
be considered a failure for the primary effectiveness endpoint.  All 
subjects free from clinically-driven re-intervention within the 

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stented segment who meet the definition of stent graft patency 
with at least 11 months (330 days) of follow-up will be considered 
successful with respect to the primary effectiveness endpoint.  
Subjects free from clinically-driven re-intervention within the 
stented segment but do not have sufficient follow-up to assess 
the primary effectiveness endpoint will be treated as missing 
data. 
The primary effectiveness hypothesis will be tested by calculating 
the one-sided 97.5% confidence limit, using the Exact method.  If 
the lower limit exceeds the performance goal of 60.4% the 
primary effectiveness hypothesis will be met. 
7.5 
SAFETY ANALYSES 
7.5.1. Primary Safety Endpoint Analysis 
The primary safety endpoint is evaluated on a per subject basis 
and will be calculated as the percent of all ITT subjects with 
sufficient follow-up that are free from all elements of the primary 
safety endpoint composite at 30 days.  The primary safety 
hypothesis will be tested by calculating the lower one-sided 97.5% 
confidence limit, using the Exact method, for the rate of freedom 
from MAEs.   If the lower limit exceeds the performance goal of 
84%, the primary safety hypothesis will be met. 
7.6 
SECONDARY ENDPOINTS AND ADDITIONAL ANALYSES 
Secondary and additional analyses will also be carried out on subgroups 
prespecified in the Statistical Analysis Plan (SAP). These analyses will be 
purely descriptive, no hypotheses will be tested for secondary endpoints 
or additional analyses. 
7.7 
FINAL CLINICAL REPORT 
A final clinical report will be prepared at the conclusion of the trial.  
Copies of the final report will be provided to each investigator and to the 
respective IRBs/ECs. 
8.0 
SPONSOR RESPONSIBLITIES 
As the Sponsor of this clinical study, PQ Bypass has the overall responsibility for 
the conduct of the study, including assurance that the study meets the 
regulatory requirements of the Food and Drug Administration (FDA) and ISO 
14155:2011 (Section 8 – OUS Sites only). In this study, PQ Bypass will have 
certain direct responsibilities and will delegate other responsibilities to 

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Independent Contractors. Together, both PQ Bypass and its Independent 
Contractors will ensure adherence to the sponsor’s general duties (21 CFR 
812.40; ISO 14155:2011 Section 8), selection of Investigators (21 CFR 812.43; ISO 
14155:2011 Section 8.2.1), monitoring (21 CFR 812.46; ISO 14155:2011 Section 
8.2.4.2), supplemental applications (21 CFR 812.35 (a) and (b)), record 
maintenance (21 CFR 812.140 (b)), and report submissions (21 CFR 812.150 (b)). 
8.1 GENERAL DUTIES 
(21 CFR 812.40; ISO 14155:2011 Section 8) 
The Sponsor’s general duties consist of submitting the IDE application to FDA, 
submitting the Investigational Plan to other applicable national regulatory 
agencies (as applicable), obtaining FDA, other national regulatory (as applicable) 
and IRB / EC approvals prior to shipping the devices, selecting qualified 
Investigators, and shipping devices only to those qualified Investigators. As the 
sponsor, PQ Bypass is also required to obtain signed study agreements, to 
provide the Investigators with the information necessary to conduct the study 
and adequate on-site training to conduct the trial, to ensure proper clinical site 
monitoring, and to provide the required reports to the Investigators, IRBs / ECs, 
other national regulatory agencies (as applicable), and FDA. 
PQ Bypass will be responsible for providing quality data that satisfies federal 
regulations and informing about serious unanticipated adverse events and 
deviations from the protocol. Written progress reports and a final report will be 
prepared in coordination with the Ultrasound, Angiographic and X-Ray Core 
Laboratories. 
8.2 SELECTION OF CLINICAL SITES & INVESTIGATORS  
(21 CFR 812.43; ISO 14155:2011 Section 8.2.1) 
PQ Bypass will select qualified clinical sites and Investigators who are 
experienced with percutaneous transluminal angioplasty and peripheral 
stenting. The Investigator must work with a qualified IRB / EC to oversee the 
rights, safety and welfare of the study participants. The clinical site must also 
have an adequate subject population and the appropriate staffing and 
equipment to meet the requirements of the study protocol and the expected 
enrollment time frames. 
8.3 MONITORING 
(21 CFR 812.46; ISO 14155:2011 Section 8.2.4.2) 

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PQ Bypass or a designate CROto monitor and oversee the conduct of the The 
DETOUR II Clinical Study.  The Sponsor and/or CRO designee will conduct 
investigational site monitoring to ensure that all Investigators are in compliance 
with the Protocol and the Investigators’ agreements. The Sponsor and/or CRO 
designee will monitor the sites to ensure that the completed eCRFs are in 
agreement with the source documentation and other records, and resolve any 
differences. Periodic phone contacts and site visits will be conducted to ensure 
that the Protocol is being followed. 
For record verification purposes, the clinical monitor and/or authorized Sponsor 
representative shall be provided access to hospital records, original laboratory 
data, and other records and data as they relate to the study and as agreed to 
with the Investigator prior to the initiation of the trial. The Investigator will also 
make available to the clinical monitor all regulatory documents, all completed 
eCRFs, informed consent documents, source documentation and other relevant 
records for all enrolled subjects at the site. It is important that the Investigator 
and other relevant site personnel are available for consultation with the clinical 
monitor during the monitoring visits and that sufficient time is devoted at the 
site to the monitoring process. 
If the Sponsor and/or their authorized representative become aware that an 
Investigator is not complying with the study protocol, the Investigator 
Agreement, Good Clinical Practices, applicable privacy standards, or any 
condition of the study imposed by the IRB / EC, the Sponsor or their authorized 
representative may immediately secure compliance or discontinue further 
shipments of the study devices. An inability to secure compliance and/or to 
complete an investigation into the factors that are inhibiting compliance may 
result in the Investigator’s termination from the study by the Sponsor. 
The Sponsor will review significant new information, including unanticipated 
serious adverse events and ensure that such information is provided to the FDA, 
other national regulatory agencies (as applicable), the Investigators, and to all 
reviewing IRBs / ECs. 
Study close-out visits will be conducted after the final follow-up visit is 
completed at each site following the resolution of any outstanding data 
discrepancies and adverse events. The remaining study devices will be the 
collected and returned to the Sponsor on or before the close out visit. A final 
study report will be generated and submitted to the Investigator and the 
appropriate study oversight authorities. Study document retention requirements 
will be reviewed with each site during the close-out visit. 

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8.4 INVESTIGATIONAL SITE TERMINATION 
The Sponsor reserves the right to terminate an investigational site from the 
Study for any of the following reasons: 
• Failure to obtain Informed Consent. 
• Failure to report Serious Adverse Events within 48 hours of knowledge. 
• Loss of or unaccountable device inventory. 
• Repeated Protocol violations or safety concerns. 
• Repeated failure to complete Case Report Forms. 
• Failure to enroll an adequate number of subjects 
8.5 INFORMED CONSENT & INSTITUTIONAL REVIEW BOARD (IRB) / ETHICS COMMITTEE (EC) 
(21 CFR Parts 50 & 56; ISO 14155:2011 Section 4) 
All subjects must provide written informed consent in accordance with the local 
clinical site’s IRB / EC. A copy of the consent form from each center must be 
forwarded to the Sponsor for review and approval prior to submitting it to the 
IRB / EC. Each site must provide the Sponsor with a copy of the clinical site’s IRB 
/ EC approval letter and the informed consent. Continuing review (e.g., 
institutional annual review) approvals for the continuation of the trial at each 
clinical site must also be forwarded to the Sponsor, as applicable. 
All Protected Health Information (PHI) to be collected in the study will be 
described in the informed consent form, and all study data will be managed in 
accordance with the Privacy Law (HIPAA) or international privacy regulations 
(GDPR), as applicable. 
8.6 RECORDS & RECORD RETENTION  
(21 CRF 812.140 (b) & (d)) 
The Sponsor and/or their designated CRO will maintain copies of 
correspondence, data, device shipments, clinical events (AEs, SAEs, MAEs) and 
supporting documentation and other records and reports related to this clinical 
study. 
The Sponsor, core laboratories and clinical sites will maintain the DETOUR II 
study records until two (2) years after the final study report is completed, or 
longer if required by local, national or international regulatory agencies. The 
Sponsor will notify each site regarding the regulatory requirements for record 
retention during the study close-out visit. 

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8.7 STUDY REPORTS 
(21 CFR 812.150(b)) 
All information and data generated in association with the study will be held in 
strict confidence and remains the sole property of the Sponsor. The Investigator 
agrees to use this information for the sole purpose of completing the study and 
for no other purpose without prior approval of the Sponsor. 
The Sponsor will submit the required FDA reports identified in this section of the 
regulation. This includes unanticipated serious adverse device effects, 
withdrawal of IRB / EC or FDA approval, current 6-month Investigators list, 
annual progress reports, recall information, final reports, investigators that use 
the device without obtaining informed consent, and significant risk device 
determinations. 
Upon receipt of the final study data and the final reports from each center, the 
Sponsor will complete a final study report. Copies of the final report will be 
provided to each Investigator. 
8.8 SUPPLEMENTAL APPLICATIONS  
(21 CFR 812.35) 
As appropriate, the Sponsor will submit changes to the study Protocol for 
national approval and subsequently to the Investigators to obtain IRB / EC 
approval. 
9.0 QUALITY ASSURANCE & ETHICAL STANDARDS 
9.1 TRIAL CONDUCT 
The trial will be performed in accordance with the relevant parts of the Code of 
Federal Regulations, ICH Guidelines for Good Clinical Practices, the European 
Standard ISO 14155:2011 (OUS sites only), the Declaration of Helsinki, and any 
regional and/or national regulations.  As the study Sponsor, PQ Bypass, has the 
overall responsibility for the conduct of the study, including the assurance that 
the study is in compliance with these guidelines, standards and requirements. 
9.2 INSTITUTIONAL REVIEW BOARDS / ETHICS COMMITTEES 
Before any subject can be enrolled in this trial, the IRB or EC for the specific 
institution must review and approve the protocol and the Informed Consent 
Form to be used.  A subject cannot be asked to sign the Informed Consent Form 
until the trial has been fully approved by the institution’s IRB/EC. A copy of the 

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study Protocol, proposed Informed Consent form, other written patient 
information and any proposed advertising material must be submitted to the IRB 
/ EC for written approval. The Sponsor or their designated CRO will require a 
copy of any IRB/EC correspondence, as well as the final IRB/EC approval letter 
and the final IRB/EC approved Informed Consent Form and approvals for 
protocol and ICF revisions on amendments from each IRB/EC before recruitment 
of subjects into the study and shipment of investigational product.  
The Investigator must submit and, where necessary, obtain approval from the 
IRB / EC as well as the FDA, for all subsequent significant protocol amendments 
and significant changes to the Informed Consent form. The Investigator should 
notify the IRB / EC of deviations from the protocol or SAEs and UADEs occurring 
at the site and other SAE/UADE reports received from PQ Bypass in accordance 
with local procedures. 
The Investigator will be responsible for obtaining annual IRB / EC approval and 
renewal throughout the duration of the study. Copies of the Investigator’s 
reports and the IRB / EC continuance of approval must be sent to PQ Bypass. 
9.3 INFORMED CONSENT 
A sample Informed Consent form template shall be provided to the Investigator 
to use to prepare for use at his/her site. The written Informed Consent 
documents should be prepared in the language(s) of the potential patient 
population. 
The reviewing IRB / EC and the sponsor must first approve the Informed Consent 
forms that are used. The Informed Consent forms that are used should be in 
accordance with the current guidelines as outlined by the FDA Regulations, GCP 
guidelines, Declaration of Helsinki, and ISO Standards (OUS sites only). 
Prior to participation in the clinical trial, each patient must give written Informed 
Consent after the context of the study has been fully explained to the patient in 
language that is easily understood by the patient. The patients must also be 
given the opportunity to read the consent, ask questions, and have those 
questions answered to their satisfaction. 
Written Informed Consent must be recorded appropriately by means of the 
subject’s dated signature. The subject will receive a copy of the Informed 
Consent form. 
9.4 PROTOCOL AMENDMENTS 

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An Investigator may not make changes to this protocol without prior approval by 
the Sponsor. All significant changes to the protocol that may affect the following 
must be submitted and approved by the FDA 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. 
Any such change to the protocol must be approved by the FDA and submitted 
and subsequently approved by the site IRB / EC. PQ Bypass will submit a copy of 
the protocol amendment to all Investigators for their IRBs / ECs to review and 
ensure the study continues to be conducted consistently across all sites. The 
investigative sites must send PQ Bypass a copy of the IRB / EC approval letter for 
the protocol amendment. 
PQ Bypass may make certain administrative changes to the protocol without 
prior approval of the FDA or IRB / EC. PQ Bypass will notify all investigative sites 
of such changes to ensure the study continues to be conducted consistently 
across all sites. The site IRBs / ECs will be notified of these changes. 
9.5 EMERGENCY ACTIONS  
PQ Bypass accepts the right of the Investigator to deviate from the protocol in an 
emergency when necessary to safeguard the life or the physical well-being of a 
study subject. The Investigator must give notice of any emergency deviations 
and justification for the deviation to PQ Bypass and the IRB / EC as quickly as 
possible after the episode, in any event no later than 24 hours after the 
emergency. 
Emergency Use of the investigational device is not permitted in this study. 
9.6 DEVIATIONS FROM THE INVESTIGATIONAL PLAN 
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 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 

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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.  For reporting purposes, PQ Bypass classifies study 
deviations as major and minor:  
Major deviation: Any deviation from subject inclusion and exclusion 
criteria, subject informed consent procedures, SAE/MAE reporting, 
device accountability discrepancies, or unauthorized device use. 
Minor deviation: Deviation from a protocol requirement such as 
incomplete/inadequate subject testing procedures, follow-ups performed 
outside specified time windows, etc. Minor Deviations that continue to 
occur at an investigational site may be classified as Major Deviations if 
corrective action is not taken to secure future compliance to the 
protocol. 
9.7 INVESTIGATOR & STAFF TRAINING 
To ensure accurate, complete and reliable data, the Sponsor or its 
representatives will provide instructional material to the sites, as appropriate; 
instruct the investigators and study personnel on the protocol, the completion of 
the CRFs, and study procedures; communicate regularly with site personnel via 
mail, email, telephone, and/or fax; and make periodic monitoring visits to the 
site.  During those visits, the Sponsor or its representatives will monitor the 
subject data recorded in the CRFs against the source documents at the site. 

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All participating investigators will be trained in the use of the PQ Bypass System 
prior to participating in the study.  PQ Bypass System training will be conducted 
by the Sponsor or its representatives.  All device training will be documented in a 
training log that will be maintained in the site regulatory binder. 
Procedural technique and experience with the PQ Bypass investigational devices 
may be assessed by clinical/engineering personnel. Observations during the 
cases will also be discussed with the Investigator and study staff. 
9.8 AUDITS AND INSPECTIONS 
The principal investigator will also allow representatives of the governing IRB or 
EC, the U.S. Food and Drug Administration (FDA), and other applicable regulatory 
agencies to inspect all study records, CRFs, and corresponding portions of the 
subject’s office and/or hospital medical records at regular intervals throughout 
the trial.  These inspections are for the purpose of verifying adherence to the 
protocol, completeness, and exactness of the data being entered onto the CRFs 
and compliance with FDA or other regulatory agency regulations. 
The principal investigator will inform the Sponsor or the Sponsor’s designee 
should they be audited or inspected by any regulatory agencies.  The Sponsor or 
the Sponsor’s designee will also inform the site if they are made aware of a 
pending audit or inspection by a regulatory agency. 
The Investigator and/or designees must be available to respond to reasonable 
requests by authorized Sponsor, CRO and regulatory agency representatives 
during the monitoring and inspection process. The Investigator must provide the 
Sponsor with copies of all correspondence that may affect the review of the 
current study (i.e., Inspection Observations) or their qualification as an 
Investigator in clinical studies conducted by the Sponsor. The Sponsor will 
provide any needed assistance to the clinical site for regulatory audits, if any. 
9.9 MONITORING PROCEDURES  
Monitoring visits to the clinical sites will be made periodically during the study, 
to ensure that all aspects of the current, approved protocol/amendment(s) are 
followed. Original source documents shall be reviewed for verification of data in 
the electronic database according to the defined monitoring plan. The 
Investigator/institution shall make all attempts to grant direct access to original 
source documents by PQ Bypass personnel, their designees, and appropriate 
regulatory authorities. It is recognized that all participating institutions may not 
have procedures for providing access to electronic health records to non-
institutional employees. In such situations, the Sponsor and/or designee shall 

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collaborate with the investigator and institution to ensure alternative access to 
the complete medical record for enrolled subjects. In the event that the original 
medical records cannot be obtained for a patient that is seen by a non-study 
physician at a non-study institution, photocopies of the original source 
documents must be made available for review. 
Site visits will be conducted to ensure that the protocol is being followed and 
that any protocol deviations are properly documented. 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. Clinical monitoring will 
include a verification that Informed Consent was properly obtained for all 
enrolled trial participants, a review of clinical records for accuracy and 
completeness, resolution of missing or inconsistent results and a review of 
source documents. The clinical monitor will verify that the eCRFs are in 
agreement with the source documentation and other records. The investigator 
will make available to the clinical monitor for review all Informed Consent 
documents, Internet access to completed eCRFs, source documentation, original 
laboratory data and other relevant records for all enrolled subjects at the site. It 
is important that the investigator and other relevant site personnel are available 
for consultation with the clinical monitors during the monitoring visits and that 
sufficient time is devoted at the site to the monitoring process. 
If a deficiency is noted during an on-site visit (or at any other time during the 
course of the trial), the clinical monitor is required to discuss the situation with 
the investigator and the Sponsor (if required) to secure compliance. 
9.10 INVESTIGATIONAL DEVICE DISTRIBUTION AND ACCOUNTABILITY 
9.10.1. INVESTIGATIONAL DEVICE DISTRIBUTION 
PQ Bypass will control the distribution of the investigational devices. Each 
investigational site will be responsible for ordering the investigational 
devices for the study. The Investigator is responsible for ensuring that the 
devices are ordered for shipment to arrive at the hospital before the 
procedure date. Devices will be shipped with an Investigational Device 
Shipment Record. This form is to be used by PQ Bypass, or distribution 
designee, and the investigational site to record any shipments of the 
investigational device. A copy is to be retained by the shipper and the 
recipient. 
9.10.2. DEVICE ACCOUNTABILITY 

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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. 
9.11 
RETURN OF DEVICES 
All unused investigational devices will be returned to the study Sponsor 
upon completion of the clinical study.  All used investigational devices will 
be properly disposed of, per institutional procedures.  Any investigational 
device that fails to perform correctly will be returned to the study 
Sponsor for analysis.  The Investigator or his/her designated 
representative is responsible for device accountability and disposition of 
all used and unused devices.  The study Sponsor or its designated 
representative will conduct device reconciliation at the completion of 
subject enrollment or at the conclusion of the study. 
IMPORTANT: Please note that the devices must be labeled with a 
“BIOHAZARD” sticker if there is reasonable belief that the device has 
come in contact with blood or infectious substances that are known or 
are believed to cause disease in animals or humans. 
9.12 
CENTRAL CORE LABS – ANGIOGRAPHY, DUPLEX ULTRASOUND AND X-RAY 
In order to ensure that the clinical data and images are analyzed in a 
controlled, non-biased manner and that the results are analyzed using a 
standardized process, all angiograms, duplex ultrasound studies and X-
rays obtained during this study per study requirements will be submitted 
to central core labs for analysis. 
The core labs will be responsible for analyzing the angiograms and 
ultrasound images according to the study eligibility criteria, the study 
endpoints and this study protocol. In addition, they will provide feedback 
to the sites and Sponsor regarding the quality of the tracings and images. 
The X-ray core lab will be assessing for stent fracture at the applicable 

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study time points. Final written summary reports of all angiograms, X-
rays, and duplex ultrasounds will be provided to the study Sponsor. 
9.13 
COVERAGE OF EXPENSES 
The treated subjects may receive nominal compensation for participating 
in the study and may be reimbursed for study specific out-of-pocket 
expenses (e.g., parking, lodging, etc) and subject to approval by Sponsor 
and/or IRB/EC. 
9.14 
CONFIDENTIALITY 
Confidentiality of subjects will be maintained throughout the trial.  A 
unique identification code will be assigned to each subject participating 
in this trial.  Any data that may be published in abstracts, scientific 
journals, or presented at medical meetings will reference a unique 
subject code and will not reveal the subject’s identity.  The Sponsor will 
make every reasonable effort to protect the confidentiality of all subjects 
participating in the trial. 
10.0 
INVESTIGATOR RESPONSIBILITIES, RECORDS & REPORTS 
The Investigators are responsible for signing the Investigator Agreement prior to 
the commencement of the study and for ensuring that this trial is conducted 
according to this study Protocol, GCPs, Declaration of Helsinki, 21 CFR Parts 50, 
54, 56 and 812, ISO 14155:2011 (Section 9 – OUS Sites only) and any other local, 
national or IRB / EC requirements that apply to Clinical Investigations at their 
center. 
It is also the Investigator’s responsibility to ensure that all sub-investigators and 
staff assisting with this study have the appropriate qualifications and that they 
complete training on the protocol, investigational devices and study procedures, 
and that subject confidentiality is respected. 
10.1 INFORMED CONSENT & INSTITUTIONAL REVIEW BOARD / ETHICS COMMITTEE  
(21 CFR Parts 50 & 56; ISO 15144:2011 Section 4) 
Because this study is collecting medical data from subjects providing written 
informed consent, the Investigator at each site is responsible for securing IRB / 
EC approval for this study protocol and the Informed Consent documents. The 
local IRB / EC for each specific institution must review and approve this study 
protocol and the specific Informed Consent form to be used at that site prior to 
enrollment of the first subject. The Sponsor must also review and approve the 
final Informed Consent documents prior to their use. The Sponsor must receive a 

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copy of any IRB / EC correspondence as well as the final approval letter and the 
final approved Informed Consent from each IRB / EC. 
The Investigator is responsible for ensuring that all applicable local and national 
(21 CFR Part 50, ISO 14155:2011 – OUS sites only) requirements, and Declaration 
of Helsinki are met when completing the informed consent process. Written, 
informed consent is to be obtained for all subjects prior to enrollment. 
The Investigator or clinical site staff will not make amendments to this Protocol 
or the Informed Consent form without PRIOR written approval from the Sponsor. 
All approved amendments must then be submitted to the local IRB / EC and 
national authorities, as appropriate for approval. 
10.2 WITHDRAWAL OF APPROVAL 
If the Investigator’s IRB or EC withdraws their approval to conduct this study for 
any reason, the Investigator must notify the Sponsor as soon as possible, but in 
no event later than five working days after the withdrawal of the approval. 
10.3 DEVICE ACCOUNTABILITY 
The Sponsor will ship investigational devices to the designated Investigators 
participating in this study following IRB / EC approval. All Investigators will be 
responsible for providing a secure storage location for the devices, supervising 
device use, and the disposal and/or return of the devices as instructed by the 
Sponsor. In addition, all Investigators will maintain records to document the 
receipt, use and disposition of all devices received by their site intended for this 
study. The Sponsor and/or designee will also maintain records of all shipments 
and disposition of the investigational devices. The Sponsor and/or their 
authorized Contract Research Organization (CRO) will routinely inspect the 
clinical site inventory records for device accountability at the clinical sites 
participating in this study. 
10.4 DATA HANDLING AND RECORD KEEPING 
10.4.1. SERIOUS ADVERSE EVENTS & MAJOR ADVERSE EVENTS 
The Investigator will report to the Sponsor by telephone, email, fax, or 
electronic CRF submission any SAE or MAE as soon as possible (within 24 
hours of the Investigator becoming aware of the event or by the end of 
the next working day). Additionally, SAEs and MAEs should be reported 
to the IRB / EC, if required per the clinical site guidelines or as directed by 
the Sponsor. The Adverse Event eCRF is to be completed and submitted 
to the Sponsor within five (5) working days of the event. The contact 

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information for reporting SAEs and MAEs is provided in the study contact 
section of this protocol. 
10.4.2. DEVICE MALFUNCTIONS OR FAILURES 
The Investigators will report any Device Malfunctions or Failures that 
occur, to the Sponsor within 24 hours of the Investigator becoming aware 
of the device malfunction or failure or by the end of the next working 
day. The report may be made by or within 24 hours via telephone, email 
or fax. The Investigator or study staff are to return the devices per the 
Instructions for Use for investigation. The Device Observation eCRF is to 
be completed and submitted to the Sponsor within five (5) working days 
of the event. The contact information for reporting Device Performance 
issues is provided in the study contact section of this protocol. 
10.4.3. DEVIATIONS FROM THE INVESTIGATIONAL PLAN 
The Investigator must notify the Sponsor of any deviation from the 
Investigational Plan. The Investigator should also notify the IRB / EC as 
required per their local requirements or as directed by the Sponsor. This 
notice must occur as soon as possible, but in no case longer than five (5) 
working days after the Investigator becomes aware of a major deviation. 
Major deviations include, but is not limited to, those that involve the 
informed consent process, the inclusion/exclusion criteria of the study, 
SAE/MAE reporting, device misuse or device accountability discrepancies, 
or any deviation that involves or leads to a serious adverse event in a 
study participant. 
10.4.4. SOURCE DOCUMENTS 
The Investigator must maintain detailed source documents on all subjects 
who are enrolled or who undergo screening in the study.  Source 
documents include subject medical records, hospital charts, clinic charts, 
investigator subject trial files, as well as the results of diagnostic tests 
(e.g., laboratory tests, hemodynamic studies). 
• The following minimum information should be entered into the 
subject’s medical record: 
• The date the subject entered the study and the subject number 
• The study protocol number and the name of the Sponsor 
• The date that Informed Consent was obtained 
• Evidence that the subject meet the study eligibility requirements 
(e.g., medical history, study procedures and/or evaluations) 
• The dates of all study related subject visits 

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• Evidence that required procedures and/or evaluations were 
completed 
• Use of any concurrent medications 
• Documentation of specific device used 
• Occurrence and status of any adverse events (AEs) 
The date the subject exited the study and a notation as to whether the 
subject completed the trial or was discontinued, including the reason for 
discontinuation 
10.4.5. CLINICAL DATA COLLECTION 
Standardized electronic case report forms (eCRF) will be used to collect 
complete and accurate records of the clinical data from the DETOUR II 
trial according to the GCPs requirements. The Investigator and/or study 
staff under his/her direction is responsible for accurately recording the 
clinical data for this study and submitting it to the Sponsor in a timely 
manner. 
10.4.6. INVESTIGATOR FINAL REPORT 
The Investigator will report information and events according to the 
timelines in the Table 6. Within three (3) months of Study completion, 
the Investigator will provide a final study report that summarizes their 
enrollment and study participation. This report should include a summary 
of enrollment, AEs, MAEs, SAEs, UADEs and Device Malfunctions and 
Failures. This report will be forwarded to the IRB / EC and the Sponsor 
after all of the enrolled subjects have completed their final follow-up visit 
or have exited the study and the study close-out visit has been 
completed, but no later than three (3) months following completion of 
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Table 6: Investigator Reporting Timelines 
Form/Report 
Submission Timeframe 
Enrollment notification  
Completion of Enrollment eCRF within 24 hours of enrollment, 
or by the end of the next working day. 
Electronic CRFs 
Completion within 3 working days of study visit. 
Angiographic, X-Ray and 
Duplex Ultrasound Images 
Submit to Core Lab within 3 working days of completion. 
Adverse Events  
(non-serious) 
Complete eCRF within 14 days of the Investigator becoming 
aware of the event. 
SAEs & MAEs 
Submit notification to Sponsor within 24 hours of the site 
becoming aware of the event, or by the end of the next 
working day; submit to the local IRB / EC as required or as 
directed by the Sponsor. 
Study Progress Reports 
As required by the local IRB / EC (minimum annually). 
Final Report to the IRB / EC Within 3 months of Study completion. 
11.0 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
The occurrence of Adverse Events will be monitored during this study.  All 
Adverse Events will be collected through 12 month follow-up and recorded on 
the Adverse Event eCRF at onset and at each follow-up visit until resolved. SAEs, 
MAEs and UADEs will be collected for the duration of the study. All device- and 
procedure-related events, all target limb related events, and all potential non-
serious events related to study requirement medications shall be reported 
throughout the trial. 
Potential adverse events associated with use of the PQ Bypass System include, 
but are not limited to the following:  

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• Access vessel (arterial / venous) 
occlusion 
• Amputation 
• Aneurysm or pseudoaneurysm  
• Arteriovenous (AV) fistula 
• Bleeding complications 
• Death 
• Device or deployment 
malfunction / failure 
• Drug reactions to antiplatelet 
agents or contrast medium 
• Embolism (peripheral or 
pulmonary) 
• Fever in absence of infection 
• Hemorrhage or hematoma  
• Hypotension/hypertension 
• Infection local or systemic 
including bacteremia or 
septicemia 
• Malapposition or migration 
• Malposition 
• Myocardial infarction 
• Pain (insertion site, leg and/or 
foot) 
• Renal insufficiency or failure 
secondary to contrast medium 
• Shock 
• Side branch vessel occlusion 
• Stenosis or occlusion 
• Stroke or transient ischemic 
attack 
• Thrombosis 
• Vessel wall trauma (dissection, 
perforation or rupture) 
• Vessel spasm 
• Venous flow disruption (deep 
vein thrombosis, phlebitis, leg 
swelling and/or development of 
varicose veins) 
• Worsening claudication 
11.1 
ADVERSE EVENTS 
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 study device or events related 
to the procedures involved. 
Adverse Device Effect: An adverse event related to the use of a medical 
device, including adverse events resulting from insufficient or inadequate 
Instructions for Use, deployment, implantation, installation or operation, 
or any malfunction of the medical device or any event resulting from user 
error or intentional misuse of the medical device. 
The Investigator is responsible for assessing the severity of the AE, the 
causal relationship between any events and the clinical study procedure, 
activities or device.  Additionally, the Investigator is responsible for 
providing appropriate treatment for the event and for adequately 
following the event until resolution.  The following categories of adverse 
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• 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. 
AEs, SAEs and endpoint events will also be classified as to their 
relationship to the study device and the study procedure as follows: 
• Definitely Related: The adverse event is directly and clearly 
related to the investigational device or procedure. 
• Probably Related: The exact relationship cannot be determined, 
but it is most likely that the adverse event and the investigational 
device or procedure are related. 
• Possibly Related: The exact relationship cannot be determined, 
but there is a reasonable likelihood that the adverse event and 
the investigational device or procedure may be related. 
• Not Related: The adverse event does not have any identified or 
perceived relationship to the investigational device or procedure. 
• Unknown: The relationship of the AE to the device or procedure 
cannot be determined. 
Pre-existing medical conditions or a repeat of symptoms reported prior 
to the PQ Bypass System procedure will not be recorded as an adverse 
event.  Pre-existing conditions that worsen during a study are considered 
adverse events.   
11.2 
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.  The following 
events (including laboratory results and outcome events) will be 
considered to be SAEs and must be reported within 24 hours or by the 
end of the next business day be reported to the study Sponsor.  These 

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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,  
o medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body 
structure or a body function, or 
o led to fetal distress, fetal death, or a congenital 
abnormality or birth defect. 
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. 
11.3 
UNANTICIPATED ADVERSE DEVICE EFFECTS (UADE) 
An unanticipated adverse device effects is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem or death was not 
previously identified in nature, severity, or degree of incidence in the 
protocol, investigator’s brochure, labeling or published literature, or any 
other unanticipated serious problem associated with a device that relates 
to the rights, safety, or welfare of the subjects. 
11.4 
ADVERSE EVENT REPORTING 
All adverse events will be captured through the 12-month visit as a part 
of this clinical study. Following the 12-month visit, only SAEs, MAEs, and 
UADEs will be collected and reportedfor the duration of the study.  All 
device- and procedure-related events and all target limb related events 
shall be reported throughout the trial.  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 

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all adverse device effects will be recorded immediately in the source 
document, and also in the appropriate electronic case report form 
(eCRF).  All clearly related signs, symptoms, and abnormal diagnostic 
procedures results should be recorded in the source documents.  All 
SAEs, UADEs, MAEs and possible serious device and/or procedure-related 
adverse events must be reported by the Investigator (or his/her 
designee) within 24 hours of becoming aware of the event or by the end 
of the next business day.  The report should include: severity, duration, 
action taken, treatment outcome and relationship to the adverse event 
to the study device, procedure, anticoagulations and dual antiplatelet 
Medications, etc. (i.e., unrelated, relation or relationship unknown). 
In the case of serious adverse events (SAE), major adverse events (MAE), 
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.  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 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. 
11.5 
REPORTING OF DEVICE FAILURES AND MALFUNCTIONS 
All reported device malfunctions or failures of the PQ Bypass System are 
required to be documented in the eCRF 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 

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a device failure or malfunction, that specific event would be recorded in 
the usual way. 
12.0 
CLINICAL EVENTS COMMITTEE 
An independent Clinical Events Committee (CEC) will be responsible for a 
systematic review and the adjudication of all major adverse events including, but 
not limited to, death, major amputations, clinically-driven target lesion 
revascularization, symptomatic deep vein thromboses.  In the case of an MAE 
with associated imaging, the CEC may review imaging assessments to assess a 
reported event. 
 
At a minimum, the CEC shall consist of at least three (3) independent physicians, 
with experience in interventional peripheral endovascular procedures.  In order 
to enhance objectivity and reduce the potential for bias, the CEC members will 
not have scientific, financial or other conflicts of interest related to the Sponsor 
or the study investigators or the investigational sites.  The CEC will operate and 
conduct all meetings and event reviews independent of the Sponsor unless 
specific expert knowledge regarding the characteristics or the function of study 
device is requested by the CEC from the Sponsor. 
 
The CEC will will meet throughout the study to adjudicate events in an ongoing 
fashion.  The adjudication process, event definitions and required source 
documentation materials for each type of event will be pre-specified in the CEC 
charter.  All adjudication decisions will be made by the CEC in an independent 
fashion based upon the review of all available medical evidence associated with 
each event. 
13.0 
DATA SAFETY MONITORING BOARD  
An independent Data Safety Monitoring Board (DSMB) will be responsible for 
the oversight and safety monitoring of the study.  Throughout the duration of 
the study, the DSMB will review accumulating safety data to monitor for the 
incidence of serious adverse events that would warrant modification or 
termination of the study according to pre-specified safety monitoring plan.  Any 
recommendations for study modification or termination prompted by concerns 
of subject safety, issues related to data monitoring or quality control will be 
submitted in writing to the Sponsor for consideration and final decision.  
However, if the DSMB at any time determines that a potential serious risk exists 
to subjects in the study, the DSMB chairman will immediately notify the 
Sponsor. 

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The DSMB will meet at regular intervals through study enrollment to review 
safety data.  DSMB responsibilities, membership, meeting frequencies and 
procedures will be outlined in the DSMB charter. 
14.0 
PUBLICATION POLICY 
PQ Bypass intends to submit the results of the primary and secondary endpoints 
for publication within 12 months of completion of the 12-month follow up.  
Publication will be pursued whether the 12-month outcomes are positive or 
negative or early termination of the study.  The publications policy for this Study 
is as follows.  Following the earliest of a) publication of the multi-center Study 
results, b) receipt of a notice from PQ Bypass stating that the multi-center Study 
has been terminated or, c) twenty-four (24) months after completion or 
termination of the Study at all Investigative sites, Investigators shall have the 
right to publish, in appropriate scientific journals or other professional 
publications, information and data collected or produced as a result of their 
participation in the Study, provided that drafts of the publications have been 
delivered to PQ Bypass for purposes of review and comment at least sixty (60) 
days prior to the first submission for publication or public release, to which 
Investigating Parties shall give due consideration.  PQ Bypass shall return 
comments to the Investigator within forty-five (45) days receipt of the draft.  In 
addition, the Investigator shall delay any proposed publication/presentation in 
the event PQ Bypass so requests to enable PQ Bypass to secure patent or other 
proprietary protection.  In all such publications, credit shall be given to 
PQ Bypass for 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 NCT03119233. 
 
 

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15.0 
STUDY DEFINITIONS  
Access Site Hemorrhage: Bleeding from the access site which requires 
transfusion, hospitalization (either admission or extended stay), or further 
treatment for management. Hemorrhage needing ≥ 2 unit RBCs will be 
considered a serious adverse event. 
Access Site Infection: Culture-proven wound infection or presumptive treatment 
with antibiotics for clinically diagnosed wound infection. 
Acute Limb Ischemia:  Results from a sudden decrease in limb perfusion, usually 
producing new or worsening signs and symptoms, and often threatening limb 
viability. 
Acute Renal Failure:  Acute post-operative renal insufficiency resulting in one or 
more of the following: (a) increase of > 1.0 mg/dl in serum creatinine from most 
recent prior measured level, and current measured absolute value is > 2.0 mg/dl; 
(b) a new requirement for dialysis. 
Allergic Reaction: An allergic reaction characterized by rash, upper respiratory 
congestion, urticaria, shortness-of-breath, or general collapse (anaphylaxis). 
Amputation:  
Major: any requirement for amputation of the target limb above the 
ankle. 
Minor: any unplanned requirement for amputation of the of the target 
limb below the ankle. 
Anemia:  Decrease from baseline in red blood cells, hemoglobin, or total blood 
volume that is associated with hemodynamic changes or requires transfusion, or 
a drop in hematocrit to below 26%. Any documented anemic event requiring ≥2 
units PRBCs will be considered an SAE. 
Angina, unstable:  Angina that increases in frequency, intensity, or duration, 
which occurs at rest, or which is new in onset. Unstable angina is a syndrome 
that is intermediate between stable angina and myocardial infarction: it is 
characterized by an accelerating or "crescendo" pattern of chest pain that lasts 
longer than stable angina, occurs at rest or with less exertion than stable angina, 
or is less responsive to medication. Unstable angina and myocardial infarction 
are considered acute coronary syndromes. 

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Ankle Brachial Index (ABI):  The ratio of systolic blood pressure measured at the 
ankle to systolic blood pressure measured at the brachial artery. It is used to 
predict the severity of peripheral arterial disease (PAD). ABIs >0.9-1.2 = normal, ≤ 
0.9 = peripheral arterial disease, < 0.4 = severe peripheral arterial disease 
(ischemic pain and ulceration). ABI > 1.2 is likely due to incompressible arteries 
and is commonly observed in association with long-standing diabetes mellitus, 
extreme old age, or calcinosis. 
Instructions for ABI Calculations: 
Obtain systolic blood pressures (SBP) for both arms (brachials) and both ankles 
[posterior tibials (PT) & dorsalis pedals (DP)]. 
Divide the higher of the two SBPs for each leg (highest between the PT and DP) 
by the higher of the two arm pressures to get the right and left ABIs. 
Arterial Occlusion / Thrombosis at Groin Puncture Site:  Angiographic or 
ultrasonographic evidence of occlusion at the puncture site limiting antegrade 
flow to the distal limb. 
Arterial Perforation/Rupture/Puncture of an Arterial Wall:  Classified as 
follows: 
Angiographic perforation: Perforation detected by the clinical site at any point 
during the procedure. 
Clinical perforation: Perforation requiring additional treatment (including efforts 
to seal the perforation), or resulting in significant extravasation of blood from 
the site, abrupt closure, limb ischemia or death. 
Arterial Pseudoaneurysm: Disruption of arterial wall confirmed by imaging study 
and requiring intervention. 
Arteriovenous Fistula (AVF): An abnormal passage or communication between 
an artery and a vein which may be due to the percutaneous introduction of 
ancillary devices (e.g., needles, catheters, guide wires) confirmed by imaging 
studies. 
Bleeding Complication (Major): Bleeding resulting in ≥3 g/dl decrease in 
hemoglobin (if hemoglobin level not available, a decrease in hematocrit of ≥ 
10%), or necessitating transfusion of ≥ 2 unit of PRBC’s /whole blood, or 
necessitates surgery/endoscopic intervention. 

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Access site: Bleeding from the arteriotomy site which requires transfusion, 
hospitalization (either admission or extended stay), or further treatment for 
management. 
Cardiac Arrhythmia: Electrical disruption of the heart rhythm requiring specific 
medication, DC shock, or pacemaker insertion to address condition. 
Cardiogenic Shock: Subject presents with SBP < 80 mm Hg for more than 30 
minutes unresponsive to fluids or requiring intravenous vasopressor agent or an 
intra-aortic balloon pump (IABP). 
Cerebral Vascular Accident (CVA): See Stroke. 
Classification of Lesion Morphology (TASC II)  
TASC II type A lesions:  
Single stenosis ≤ 10 cm in length 
Single occlusion ≤ 5 cm in length 
TASC II type B lesions: 
Multiple lesions (stenosis or occlusions), each ≤ 5 cm  
Single stenosis or occlusion ≤ 15 cm not involving the infrageniculate 
popliteal artery  
Single or multiple lesions in the absence of continuous tibial vessels to 
improve inflow for a distal bypass 
Heavily calcified occlusions ≤ 5 cm in length 
Single popliteal stenosis 
TASC II type C lesions: 
Multiple stenosis or occlusions totaling > 15 cm, with or without heavy 
calcification 
Recurrent stenosis or occlusions that need treatment after two 
endovascular interventions 

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Complex type C lesions are lesion lengths ≥ 24 cm with a chronic total 
occlusion or in-stent restenosis 
TASC II type D lesions: 
Chronic total occlusion of the common or superficial femoral arteries (> 
20 cm, involving the popliteal artery) 
Chronic total occlusion of the popliteal artery and proximal trifurcation 
vessels 
Closure, Abrupt: Occurrence of new (during the index procedure), persistent 
slow, reduced, or loss of flow within the target vessel that requires intervention 
other than the index or adjunct treatment. Abrupt closure may also be referred 
to as acute occlusion if there is a total loss of flow.  
Closure, Late: Target lesion site occlusion that occurs greater than 30 days after 
the index procedure is completed (e.g., the subject has left the treatment area). 
Closure, Subacute: Target lesion site occlusion that occurs after the index 
procedure is completed (e.g., the subject has left the treatment area) and within 
30 days of procedure. 
Contrast-Induced Nephropathy: Associated with contrast agent resulting in > 
25% increase in serum creatinine or an absolute value of > 0.5 mg/dl. 
Contrast Media Reaction: An allergic reaction, immediate or delayed, associated 
with the intravascular administration of contrast media that results in symptoms 
(e.g. itching, hives) or physiologic changes requiring treatment (e.g. anaphylactic 
reaction) or death. 
Critical Limb Ischemia (CLI): Clinical manifestation of peripheral arterial disease 
characterized by Rutherford Clinical Scale Category of 4-6. For the purposes of 
this study, only subjects with Rutherford Clinical Scale Category of 3, 4 and 5, are 
eligible for enrollment. 
Death:  Death is divided into 2 categories:  
▪ Cardiovascular death is defined as death due to any of the 
following: 
• Acute myocardial infarction. 
• Sudden cardiac death. 
• Death due to heart failure. 

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• Death due to stroke. 
• Death due to other cardiovascular causes (e.g., 
procedures, hemorrhage, or other cardiovascular causes). 
• Death not attributable to any other cause (e.g., 
undetermined cause of death). 
▪ Non-cardiovascular death is defined as a death not due to 
cardiovascular causes (as listed above). 
Deep Vein Thrombosis (DVT): Thrombosis of a deep vein, as confirmed by 
imaging study or direct visualization. 
Femoropopliteal DVT: DVT involvement limited to the superficial femoral or 
popliteal veins, with or without distal (e.g., toward foot) DVT involvement, based 
on duplex ultrasound exam. 
Iliofemoral DVT: DVT involvement of the common or external iliac veins or the 
common femoral vein, with or without distal (e.g., toward foot) DVT 
involvement, based on duplex ultrasound exam. 
De Novo Lesion: An obstructive or occlusive lesion without previous 
endovascular or surgical intervention 
Device Failure: A device that is used in accordance with the Instructions for Use, 
but does not perform according to the Instructions for Use and negatively 
impacts the treatment. 
Device Malfunction: A malfunction of a device is an unexpected change to the 
device that is contradictory to the Instructions for Use and may or may not affect 
device performance. 
Dissection: Disruption of an arterial wall resulting in separation of the intimal 
layer. May or may not be flow limiting. 
Dissection Classifications (National Heart, Lung and Blood Institute – NHLBI) 
Type A: Small radiolucent area within the lumen of the vessel 
disappearing with the passage of the contrast material. 
Type B: Appearance of contrast medium parallel to the lumen of the 
vessel disappearing within a few cardiac cycles. 
Type C: Dissection protruding outside the lumen of the vessel persisting 
after passage of the contrast material. 

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Type D: Spiral shaped filling defect with our without delayed run-off of 
the contrast material in the antegrade flow. 
Type E: Persistent luminal filling defect with delayed run-off of the 
contrast material in the distal lumen. 
Type F: Filling defect accompanied by total coronary occlusion. 
Embolization, Distal: Any distal emboli confirmed by imaging. 
Embolization, Symptomatic: Clinical signs or symptoms of distal emboli detected 
in the treated limb distal to the treated lesion after the index procedure or noted 
angiographically and requiring mechanical or pharmacologic means to improve 
flow. This includes new abrupt occlusions or filling defects. 
Enrollment: Subjects who are consented and meet all the study inclusion criteria 
and none of the study exclusion criteria and are treated or treatment is 
attempted with the study device will be considered enrolled into the study. 
Subjects who do not meet all inclusion and exclusion criteria (e.g., including 
ability to cross the lesion with a guidewire, target reference vessel diameter, 
patent tibioperoneal artery in the target limb, etc.) will be considered an 
angiographic screen failure and will not be followed in the study (no data will be 
collected on these subjects). 
Hematoma: Collection of blood (or its degradation products) that exceeds 8 cm 
in diameter, requires treatment, or prolongs hospitalization. 
Hypertension: Systolic BP >140 mmHg, or diastolic >90 mmHg requiring specific 
medical therapy. 
Hypotension: Any prolonged systolic blood pressure <80 mmHg associated with 
symptoms and requiring intravenous vasopressor medications. 
Infection, access site: Infection at the vascular access site, documented by lab 
culture or clinical evidence requiring medical treatment (irrigation, debridement, 
antibiotics, etc.) to resolve.  
Infection, systemic: Systemic infection documented by positive lab culture or 
clinical evidence, requiring medical treatment to treat and resolve. 
Intention to Treat (ITT): The principle of including outcomes of all subjects in the 
analysis who are enrolled and treated (attempted or completed) into the study, 
regardless of noncompliance, Protocol deviations, or withdrawal. 

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Limb Ischemia: Deficient supply of oxygenated blood to the tissues in the limbs 
that is due to obstruction of the inflow of arterial blood characterized by pain 
and/or discoloration of the limb and/or tissue loss. 
Luminal Patency: Restenosis <50% as determined by angiography or duplex 
ultrasound. 
Major Adverse Event (MAE):  An MAE comprises the following: Death, Clinically-
Driven Target Lesion Revascularization (CD-TLR), Amputation of the Treated 
Limb, Symptomatic Deep Vein Thrombosis (DVT), Pulmonary Embolism, or 
procedure-related bleeding requiring any transfusion of packed red blood cells 
or surgery. 
Major Adverse Limb Events (MALE):  A Major Adverse Limb Event (MALE) 
defined as above-ankle amputation or major reintervention including placement 
of a new bypass graft, interposition graft, thrombectomy, or thrombolysis. 
Myocardial Infarction (MI): Evidence of myocardial necrosis in a clinical setting 
consistent with myocardial ischemia, requiring a combination of evidence of 
myocardial necrosis [either changes in cardiac biomarkers (e.g., troponins or CK-
MB) or post-mortem pathological findings] and supporting information devired 
from the clinical presentation, electrocardiographic changes, or the results of 
myocardial or coronary artery imaging. 
Patency, Primary Vessel: Vessel patency at a given time point will be determined 
by the absence of clinically-driven target lesion revascularization and absence of 
recurrent target lesion diameter stenosis > 50% by imaging (e.g., invasive 
angiography or most commonly, duplex ultrasonography). Luminal diameter is 
assessed by core lab using angiography or duplex ultrasound imaging. Loss of 
primary stent patency is deemed when peak systolic velocity ratio (PSVR) is >2.5, 
or where angiography reveals >50% diameter stenosis, or where the subject 
undergoes clinically-driven TLR. When both imaging modalities are available, 
angiography takes precedence.  
Patency, Tibioperoneal Run-Off: Subject has at least one patent tibioperoneal 
run-off vessel with <50% stenosis confirmed by angiography at time of 
enrollment. 
Perforation: Puncture of an arterial wall. 
Pseudoaneurysm: Disruption of the arterial wall characterized by an out-
pouching or pocket with swirling, flowing blood outside of the confines of the 
arterial lumen. 

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Recurrent Occlusion: Occlusion (i.e., total obstruction of vessel lumen) after a 
successful canalization.   
Recurrent Thrombosis: Thrombosis (i.e. sub-total obstruction of vessel lumen) 
following successful treatment. 
Reference Vessel Diameter, Proximal (RVDprox): Diameter of normal vessel 
immediately proximal to the treated segment. 
Reference Vessel Diameter, Distal (RVDdist): Diameter of normal vessel 
immediately distal to the treated segment. 
Renal Failure (Acute): Acute post-operative renal insufficiency resulting in one or 
more of the following: (a) increase of > 1.0 mg/dl in serum creatinine from most 
recent prior measured level, and current measured absolute value is > 2.0 mg/dl; 
(b) a new requirement for dialysis. 
Renal Insufficiency: An increase in serum creatinine of ≥ 1.0 mg/dl over previous 
value requiring medical treatment but which does not require dialysis to resolve. 
Respiratory Failure: New onset of respiratory insufficiency that requires 
placement of endotracheal tube and/or pneumothorax with or without chest 
tube. 
Respiratory Insufficiency: Deterioration of subject’s respiratory efforts that 
require supportive or medical treatment. 
Restenosis: Reoccurrence of narrowing or blockage or target lesion. Recurrence 
of ≥ 50% diameter stenosis within 1 cm proximal and/or distal to the target 
lesion as measured by duplex ultrasound (PSV ≥ 2.5) or angiography (note: in 
cases where both imaging modalities are available, the angiography will take 
precedence). 
Retroperitoneal Bleed: Bleeding into the back of the abdomen from a vascular 
access or puncture site. 
Rutherford Clinical Category Scale: Clinical scale identifying three grades of 
claudication and three grades of critical limb ischemia ranging from rest pain 
alone to minor and major tissue loss.  
Category 
Clinical Description 
0 
Asymptomatic 

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1 
Mild claudication 
2 
Moderate claudication 
3 
Severe claudication 
4 
Ischemic rest pain 
5 
Minor tissue loss 
6 
Ulceration or gangrene 
Stent Fracture: Defined as clear interruption of stent strut observed in a 
minimum of two projections, determined by core lab examination of X-ray 
images. 
Stent Strut Fracture Types:  
Type 0: 
No strut fractures.  
Type I: Single strut fracture only. 
Type II: 
Multiple single strut fractures that can occur at different 
sites.  
Type III: 
Multiple strut fractures resulting in complete transection 
of the stent, without displacement of the stent segments. 
Type IV:  
Multiple strut fractures resulting in displacement of 
segments of the stent. 
Type V: 
Spiral strut fracture. 
Stroke: Any neurological deficit defined as an acute episode of focal or global 
neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as 
a result of hemorrhage or infarction. May be further categorized as:  
Ischemic Stroke: defined as an acute episode of focal cerebral, spinal, or retinal 
dysfunction caused by infarction of central nervous system tissue. 
Hemorrhagic Stroke: defined as an acute episode of focal or global cerebral or 
spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid 
hemorrhage. 

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Target Lesion Revascularization, Clinically-driven (CD-TLR): Clinically-driven 
target lesion revascularization is defined as target lesion revascularization 
performed due to target lesion diameter stenosis > 50% AND either evidence of 
clinical or functional ischemia (e.g., recurrent/progressive intermittent 
claudication, critical limb ischemia) OR recurrence of the clinical syndrome for 
which the initial procedure was performed. 
Thrombocytopenia: A persistent decrease in the number of blood platelets to 
subnormal levels. 
Toe Brachial Index (TBI): A Toe Brachial Index (TBI) is performed when the ABI or 
Ankle Brachial Index is abnormally high due to plaque and calcification of the 
arteries in the leg; this is caused by atherosclerosis and is most often found in 
diabetic patients. The abnormally high ABI is >1.3. 
Instructions for TBI Calculations: 
Obtain systolic blood pressures (SBP) for both arms (brachials) and both great 
toes. 
Divide the higher of the two SBPs for each leg (highest between the PT and DP) 
by the great toe pressure to get the right and left TBIs. 
Thrombus: Blood clot that obstructs a blood vessel. 
Transient Ischemic Attack: A neurological event defined as a transient episode 
of focal neurological dysfunction caused by brain, spinal cord, or retinal 
ischemia, without acute infarction. 
16.0 
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29 Schlager O, Dick P, Sabeti S, et al. Long-Segment SFA Stenting – the Dark 
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33 Taneja M, Tay KH, Sebastian M, et al. Self-expanding Nitinol stents in 
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34 Surowiec SM, Davies MG, Eberly SW, et al. Percutaneous angioplasty and 
stenting of the superficial femoral artery. J Vasc Surg. 2005; 41:259-78. 
35 Nasr MK, McCarthy RJ, Hardman J, et al. The Increasing Role of Percutaneous 
transluminal Angioplasty in the Primary Management of Critical Limb 
Ischaemia. Eur J Vasc Endovasc Surg. 2002;23:398-403. 
36 BASIL Trial Participants. Bypass versus angioplasty in severe ischemia of the 
leg (BASIL): multicenter, randomized controlled trial. Lancet. 2005;366:1925-
1934. 
37 Lammer J, Dake M, Bleyn J, et al. Peripheral Arterial Obstruction: Prospective 
Study of Treatment with a Transluminally Placed Self-expanding Stent-Graft. 
Radiology. 2000;217:95-104. 
38 Alimi YS, Hakam Z, Hartung O, et al. Efficacy of Viabahn in the Treatment of 
Severe Superficial Femoral Artery Lesions: Which Factors Influence Long-
term Patency? Eur J Vasc Endovasc Surg. 2008;35:346-352. 
39 Lepantalo M, Laurila K, Roth WD, et al. PTFE Bypass or Thrupass for 
Superficial Femoral Artery Occlusion? A Randomised Controlled Trial. Eur J 
Vasc Endovasc Surg. 2009;37:578-584. 
40 Bauermeister, G. Endovascular Stent Grafting in the Treatment of superficial 
Femoral Artery Occlusive Disease. J Endovasc Ther. 2001;8:315-320. 

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APPENDIX I:  INFORMED CONSENT FORM 
 
 

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APPENDIX II:  INSTRUCTIONS FOR USE (IFU)