Chronic Total Occlusion Percutaneous Coronary Intervention CTO-PCI Study
Phase: NA
Conditions: Chronic Total Occlusion, Ischemic Heart Disease, Chronic Total Occlusion of Coronary Artery
Sponsor: Vascular Solutions LLC

Teleflex Incorporated 
 
Document ID: ST-2955 
CTO-PCI Study 
 
Rev.: C 
 
 
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Clinical Study Protocol 
 
Chronic Total Occlusion Percutaneous Coronary Intervention 
CTO-PCI Study 
 
Study Number: ST-2955 
Revision: C, 04-Feb-2020  
 
Vascular Solutions LLC 
(a subsidiary of Teleflex Incorporated) 
6464 Sycamore Court North 
Minneapolis, MN 55369 USA 
 
 
 
 
 
 
THIS STUDY PROTOCOL CONTAINS CONFIDENTIAL INFORMATION FOR USE BY THE INVESTIGATORS 
AND THEIR DESIGNATED REPRESENTATIVES PARTICIPATING IN THE STUDY. IT SHOULD BE HELD 
CONFIDENTIAL AND MAINTAINED IN A SECURE LOCATION. IT SHOULD NOT BE COPIED OR MADE 
AVAILABLE FOR REVIEW BY ANY UNAUTHORIZED PERSON OR FIRM. 
 
 
 

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Document ID: ST-2955 
CTO-PCI Study 
 
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Signatures 
 
 
Signature: 
 
Date: 
 
Sponsor 
Jill Munsinger, Vice President of Regulatory, Teleflex Incorporated 
Signature: 
 
Date: 
 
Sponsor 
Chris Buller, MD, Medical Director, Teleflex Incorporated 
Signature: 
 
Date: 
 
Co-National Principal Investigator 
David Kandzari, MD, Interventional Cardiologist, Piedmont Heart Institute 
Signature: 
 
Date: 
 
Co-National Principal Investigator 
Dimitri Karmpaliotis, MD, Interventional Cardiologist, New York Presbyterian Hospital 
 
Signature: 
 
Date: 
 
CRO 
Scott Brown, PhD, Statistician, BRIGHT Research Partners 
 
 
 
 
 

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Principal Investigator Signature 
 
 
 
I have read the clinical study protocol and agree to adhere to the requirements of this protocol in 
accordance with the ICH guidelines for good clinical practices, ISO 14155, and applicable FDA 
regulations. 
 
Printed Name:  
Site #:  
 
Signature: 
 
Date: 
 
 
 
 
 
 
 

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Document ID: ST-2955 
CTO-PCI Study 
 
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CLINICAL STUDY PROTOCOL SYNOPSIS 
CTO-PCI STUDY 
Teleflex Study Number: ST-2955 
Study Title 
Chronic Total Occlusion Percutaneous Coronary Intervention 
CTO-PCI Study 
Identifying 
Regulatory Numbers 
FDA IDE number – G190013 
Clinicaltrials.gov – NCT03988166 
Study Objective 
To evaluate angiographic confirmation of placement of any guidewire beyond 
the CTO, in the true vessel lumen, in patients undergoing CTO percutaneous 
coronary intervention (PCI) in which at least one Teleflex guidewire and at least 
one Turnpike catheter are used. The data captured in this study will be used to 
support U.S. Food and Drug Administration (FDA) 510(k) clearance for CTO 
indications. 
Device Description 
Study devices include the GuideLiner® V3 catheter, TrapLiner® catheter, 
Turnpike® catheter, and a series of five coronary guidewires (SpectreTM 
guidewire, R350TM guidewire, RaiderTM guidewire, WarriorTM guidewire, and 
BanditTM guidewire). All study devices are currently 510(k) cleared for non-CTO 
indications. 
Device Indications 
• 
GuideLiner catheters are intended to be used in conjunction with guide 
catheters to access discrete regions of the coronary and/or peripheral 
vasculature, to facilitate placement of interventional devices, and to assist 
in crossing de novo chronic total occlusions (CTO). 
• 
The TrapLiner catheter is intended for use in conjunction with guide 
catheters to access discrete regions of the coronary and/or peripheral 
vasculature, to facilitate placement of interventional devices, to facilitate the 
exchange of an interventional device while maintaining the position of a 
guidewire within the vasculature, and to assist in crossing de novo chronic 
total occlusions (CTO). 
• 
The Turnpike catheters are intended to be used to access discrete regions 
of the coronary and/or peripheral vasculature. They may be used to 
facilitate placement and exchange of guidewires, to subselectively 
infuse/deliver diagnostic and therapeutic agents, and to assist in crossing 
de novo coronary chronic total occlusions (CTO).  
• 
The Teleflex guidewires are intended for use in percutaneous procedures to 
introduce and position catheters and other interventional devices within the 
coronary and peripheral vasculature, including use in crossing or assisting 
in crossing de novo coronary chronic total occlusions (CTO).  
Study Design 
A prospective, multicenter, single-arm, intent-to-treat, literature-controlled 
clinical study. 

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CTO-PCI Study 
 
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Number of Sites & 
Subjects 
The study will be conducted in up to 15 investigational sites in the U.S. This 
study will enroll up to 150 patients to provide adequate powering for hypothesis 
testing and an evaluable sample size of at least 135 patients. 
Study Population 
The population for this study is subjects with signs and/or symptoms considered 
typical of ischemic heart disease attributed to a de novo CTO in a native 
coronary artery who are suitable candidates for a percutaneous 
revascularization. 
Primary Endpoint 
Procedure success through discharge or 24 hours post-procedure, whichever 
comes first.  
• 
Procedure success is defined as angiographic visualization of any 
guidewire in a position either distal or proximal to the occlusion depending 
on the route of access and the absence of in-hospital major adverse 
cardiac events (MACE). 
• 
MACE defined as any serious adverse experience that includes cardiac 
death, target lesion revascularization, or post-procedural MI (Q-wave or 
non-Q-wave, with CK-MB > 3 ULN). 
Secondary 
Endpoints 
• 
Frequency of successful recanalization (defined as angiographic 
confirmation of crossing the chronic total occlusion and restoring blood flow 
to the affected area). 
• 
Frequency of MACE through discharge or 24 hours post-procedure, 
whichever comes first (in-hospital), and at 30 days post-procedure. The 
components of MACE will also be reported separately. 
• 
Frequency of clinically significant perforation (defined as any perforation 
resulting in hemodynamic instability and/or requiring intervention including 
pericardiocentesis, embolization, prolonged balloon occlusion, stent graft, 
or comparable therapy). 
• 
Procedural success according to crossing technique. 
• 
Technical success.  
Study Eligibility 
Criteria 
Subjects must meet all of the following inclusion criteria: 
General inclusion criteria 
1. At least 18 years of age at the time of consent 
2. Experiencing clinical symptoms considered suggestive of ischemic heart 
disease (e.g., chest pain or discomfort, heart failure) or has evidence of 
myocardial ischemia (e.g., abnormal functional study) attributed to the CTO 
target vessel and is scheduled for clinically indicated percutaneous 
revascularization 
3. Subject is eligible and consents to undergo PCI procedure 
4. Acceptable candidate for percutaneous transluminal coronary angioplasty 
(PTCA), stenting, and emergency CABG 
5. Willing and able to sign a study Informed Consent Form (ICF) approved by 
a local or central Institutional Review Board (IRB) 
6. Female subjects of childbearing potential must have a negative pregnancy 
test per standard of care for PCI and be practicing contraception 

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CTO-PCI Study 
 
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Angiographic inclusion criteria 
7. A minimum of one de novo lesion with at least one target segment in a 
native coronary vessel meeting the definition of CTO (any non-acute total 
coronary occlusion fulfilling the angiographic characteristics consistent with 
high-grade native coronary stenosis (Thrombolysis in Myocardial Infarction 
(TIMI) score of 0 or 1) and estimated to be in duration of ≥ 3 months by 
clinical history and/or comparison with antecedent angiogram or 
electrocardiogram) 
Subjects must not meet any of the following exclusion criteria: 
General exclusion criteria 
1. History of allergy to iodinated contrast that cannot be effectively managed 
medically 
2. Evidence of acute myocardial infarction (MI) within 72 hours prior to the 
intended treatment defined as CK-MB greater than 3 times the upper limit of 
normal (ULN) 
3. Previous coronary interventional procedure of any kind within 30 days prior 
to the procedure 
4. Any contraindication to cardiac catheterization or to any of the standard 
concomitant therapies used during routine cardiac catheterization and PCI 
(e.g., aspirin, clopidogrel, unfractionated heparin) 
5. Target lesion requires treatment with another device, after successful 
crossing with a study device, other than PTCA devices prior to stent 
placement 
6. Atherectomy procedure is planned for the target lesion 
7. Known history of clinically significant abnormal laboratory findings ≤ 14 days 
prior to enrollment, including:  
• 
Neutropenia (<1000 neutrophils/mm3)  
• 
Thrombocytopenia (<100,000 platelets/mm3) 
• 
AST, ALT, alkaline phosphatase, or bilirubin > 1.5 × ULN 
• 
Serum creatinine >2.0 mg/dL 
8. Evidence of current clinical instability including the following: 
• 
Sustained systolic blood pressure <100 mmHg or cardiogenic shock 
• 
Acute pulmonary edema or severe congestive heart failure (CHF). 
Severe CHF is defined as NYHA Class IV 
• 
Suspected acute myocarditis, pericarditis, endocarditis, or cardiac 
tamponade 
• 
Suspected dissecting aortic aneurysm 
• 
Hemodynamically significant valvular heart disease, hypertrophic 
cardiomyopathy, restrictive cardiomyopathy, or congenital heart 
disease 

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CTO-PCI Study 
 
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9. History of stroke or transient ischemic attack within 6 months prior to 
procedure 
10. Active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to 
procedure 
11. History of bleeding diathesis or coagulopathy or refusal of blood transfusions 
12. Other pathology such as cancer, known mental illness, etc., which might, in 
the opinion of the Investigator, put the patient at risk or confound the results 
of the study 
13. Unable or unwilling to comply with the protocol 
14. Currently participating in an investigational drug or device study that has not 
completed the primary endpoint or that clinically interferes with the current 
study endpoints; or requires coronary angiography, intravascular ultrasound, 
or other coronary artery imaging procedures 
Angiographic exclusion criteria 
15. Occlusion involves segment within previous stent (“in-stent occlusions”) 
16. Extensive lesion-related thrombus (TIMI thrombus grade 3 or 4) 
17. Previous stenting (drug-eluting or bare metal) in the target vessel unless the 
following conditions are met: 
• 
It has been at least 9 months since the previous stenting 
• 
Target lesion is ≥15 mm away from the previously placed stent 
• 
Previously stented segment (stent plus 5 mm on either side) has no 
more than 40% diameter stenosis, based on visual estimate 
18. Target vessel has other lesions proximal to the total occlusion identified with 
> 75% diameter stenosis based on visual estimate; exception: planned 
stenting of a lesion proximal to the target lesion that can be covered by a 
single stent (i.e., tandem lesions) is acceptable 
Study Sponsor 
Vascular Solutions LLC  
(a subsidiary of Teleflex Incorporated) 
6464 Sycamore Court North 
Minneapolis, MN 55369 USA 
Jill Munsinger 
Vice President of Regulatory 
Jill.Munsinger@teleflex.com 
Direct: 763-762-2649 
Cell: 651-270-0572 
Contract Research 
Organization (CRO) 
BRIGHT Research Partners 
730 2nd Avenue South, Suite 500 
Minneapolis, MN 55402 
Telephone: 612-345-4544 (general office line) 
www.brightresearchpartners.com 
Angiographic Core 
Lab 
Alexandra Lansky, MD 
Director, Interventional Cardiovascular Research 
Yale Cardiovascular Research Group 
135 College Street, Suite 101 
New Haven, CT 06510 
Telephone: (203) 737-2142 
Cell: (917) 821-8281 
Alexandra.Lansky@yale.edu 
   
 

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Document ID: ST-2955 
CTO-PCI Study 
 
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TABLE OF CONTENTS 
1.0 
ABBREVIATIONS .........................................................................................................12 
2.0 
INTRODUCTION ...........................................................................................................13 
3.0 
REGULATORY CLASSIFICATION ................................................................................14 
4.0 
TREATMENT DESCRIPTION .......................................................................................14 
4.1 
Device Description .....................................................................................................14 
4.1.1 
Guide Extension Catheters ....................................................................................14 
4.1.2 
Turnpike Catheter ..................................................................................................15 
4.1.3 
Guidewires .............................................................................................................16 
4.1.4 
Justification for Minimum Number of Device Uses .................................................17 
4.2 
Principle of Operation / Mechanism ...........................................................................18 
4.3 
Indications for Use .....................................................................................................19 
5.0 
OBJECTIVE ..................................................................................................................19 
6.0 
STUDY POPULATION ..................................................................................................19 
7.0 
ENDPOINTS .................................................................................................................20 
7.1 
Primary Endpoint .......................................................................................................20 
7.2 
Secondary Endpoints .................................................................................................20 
7.3 
Statistical Methods ....................................................................................................20 
7.3.1 
Analysis Datasets ..................................................................................................20 
7.3.2 
General Principles .................................................................................................20 
7.3.3 
Analysis of Primary Endpoint .................................................................................20 
7.3.4 
Analysis of Secondary Endpoints ...........................................................................21 
7.3.5 
Safety Analysis ......................................................................................................21 
7.3.6 
Sample Size ..........................................................................................................21 
7.4 
Statistical Analysis Plan .............................................................................................22 
8.0 
STUDY DESIGN ...........................................................................................................22 
8.1 
Overall Design ...........................................................................................................22 
8.2 
Number of Sites & Subjects .......................................................................................22 
8.3 
Study Duration ...........................................................................................................22 
8.4 
Subject Eligibility Criteria ...........................................................................................22 
8.4.1 
Inclusion Criteria ....................................................................................................22 
8.4.2 
Exclusion Criteria ...................................................................................................23 

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9.0 
STUDY METHODOLOGY .............................................................................................24 
9.1 
Study Summary & Schema ........................................................................................24 
9.2 
Screening ..................................................................................................................26 
9.3 
Informed Consent ......................................................................................................26 
9.3.1 
Vulnerable Population ............................................................................................26 
9.4 
Point of Enrollment & Numbering of Study Subjects ..................................................26 
9.5 
Schedule of Visits & Testing Requirements ...............................................................27 
9.6 
Subject Assessments & Study Procedures ................................................................27 
9.6.1 
Baseline .................................................................................................................27 
9.6.2 
Pre-PCI Procedure Angiogram ..............................................................................28 
9.6.3 
PCI Procedure .......................................................................................................28 
9.6.4 
6 – 12 Hours Post-Procedure .................................................................................29 
9.6.5 
18 – 24 Hours Post-Procedure / Discharge ............................................................29 
9.6.6 
Thirty (30) Days Post-Procedure ............................................................................30 
9.6.7 
Early Withdrawal/Premature Discontinuation of Subjects .......................................30 
10.0 
MEASURES TO AVOID & MINIMIZE BIAS ...................................................................30 
10.1 
Clinical Events Committee .........................................................................................30 
10.2 
Angiographic Core Laboratory ...................................................................................31 
11.0 
ADVERSE EVENTS ......................................................................................................31 
11.1 
Adverse Event Definitions ..........................................................................................31 
11.2 
Adverse Event Collection & Documentation ...............................................................31 
11.3 
Adverse Event Reporting Timeframes .......................................................................32 
11.4 
Adverse Event Relationship .......................................................................................32 
12.0 
RISK/BENEFIT ANALYSIS ............................................................................................33 
12.1 
Potential Benefits of Study Participation ....................................................................33 
12.2 
Alternative Treatment ................................................................................................33 
12.3 
Potential Risks Associated with Study Participation ...................................................33 
12.4 
Methods to Minimize Risks ........................................................................................34 
12.5 
Risk-to-Benefit Rationale ...........................................................................................34 
13.0 
ADMINISTRATIVE PROCEDURES ..............................................................................35 
13.1 
Records & Reports ....................................................................................................35 
13.1.1 
Case Report Forms ............................................................................................35 
13.1.2 
Sponsor / CRO Study Records ..........................................................................35 

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Document ID: ST-2955 
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13.1.3 
Investigator Study Records ................................................................................35 
13.1.4 
Investigator Reporting Requirements .................................................................35 
13.1.5 
Record Storage & Retention ..............................................................................36 
13.2 
Data Management .....................................................................................................36 
13.3 
Device Accountability .................................................................................................36 
13.4 
Site Selection ............................................................................................................37 
13.5 
Site Training ..............................................................................................................37 
13.6 
Site Monitoring ...........................................................................................................37 
13.7 
Institutional Review Board (IRB) ................................................................................38 
13.8 
Protocol Deviations ....................................................................................................38 
13.9 
Protocol Amendments ...............................................................................................38 
13.10 Study Termination .....................................................................................................39 
13.11 Subject Confidentiality ...............................................................................................39 
13.12 Statements of Compliance .........................................................................................39 
13.13 Publications & Public Disclosure ................................................................................39 
13.14 Study Contacts ..........................................................................................................40 
14.0 
DEFINITIONS ................................................................................................................40 
15.0 
REFERENCES ..............................................................................................................46 
16.0 
REVISION HISTORY ....................................................................................................48 
APPENDIX A: GUIDELINER CATHETER INVESTIGATIONAL INSTRUCTIONS FOR USE ....49 
APPENDIX B: TRAPLINER CATHETER INVESTIGATIONAL INSTRUCTIONS FOR USE ......50 
APPENDIX C: TURNPIKE CATHETER INVESTIGATIONAL INSTRUCTIONS FOR USE ........51 
APPENDIX D: SPECTRE GUIDEWIRE INVESTIGATIONAL INSTRUCTIONS FOR USE........52 
APPENDIX E: RAIDER GUIDEWIRE INVESTIGATIONAL INSTRUCTIONS FOR USE ...........53 
APPENDIX F: WARRIOR GUIDEWIRE INVESTIGATIONAL INSTRUCTIONS FOR USE........54 
APPENDIX G: BANDIT GUIDEWIRE INVESTIGATIONAL INSTRUCTIONS FOR USE ...........55 
APPENDIX H: R350 GUIDEWIRE INVESTIGATIONAL INSTRUCTIONS FOR USE ................56 
 
LIST OF FIGURES 
Figure 1: GuideLiner Catheter ...................................................................................................15 
Figure 2: TrapLiner Catheter .....................................................................................................15 
Figure 3: Turnpike Catheters .....................................................................................................16 

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Figure 4: Study Flow Diagram ................................................................................................25 
 
LIST OF TABLES 
Table 1: Study Device Regulatory Clearance ............................................................................14 
Table 2: Principles of Operation ................................................................................................18 
Table 3: Investigational Indications for Use ...............................................................................19 
Table 4: Visits & Testing Requirements ....................................................................................27 
Table 5: Procedure-Related Medications Recommendations ....................................................29 
Table 6: Investigator Reporting Requirements ..........................................................................36 
 
 
 

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1.0 
ABBREVIATIONS 
The following is a list of abbreviations used in the body of this document. Abbreviations solely 
used in tables (e.g., table headers) are described in the table footer and are not included below. 
ACE 
Angiotensin converting enzyme 
ACT 
Activated clotting time 
ADE 
Adverse device effect 
AE 
Adverse event 
ALT 
Alanine aminotransferase 
ARB 
Angiotensin receptor block 
AST 
Aspartate aminotransferase 
CABG 
Coronary artery bypass graft 
CAD 
Coronary artery disease 
CEC 
Clinical events committee 
CFR 
Code of federal regulations (U.S.) 
CHF 
Congestive heart failure 
CK 
Creatine kinase 
CK-MB 
Creatine kinase with M (muscle) and B (brain) subunits 
CRF 
Case report form 
(e)CRF 
(electronic) case report form 
CRO 
Contract Research Organization 
CTO 
Chronic total occlusion 
CV 
Curriculum vitae 
EDC 
Electronic data capture 
FAS 
Full analysis set 
FDA 
Food and Drug Administration (U.S.) 
GCP 
Good clinical practice 
GUSTO 
Global Use of Strategies to Open Occluded Coronary Arteries 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed consent form 
ICH 
International Conference on Harmonization 
IFU 
Instructions for use 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
MACE 
Major cardiac adverse event 
MDR 
Medical Device Reporting (to FDA) 
MI 
Myocardial infarction 
NYHA 
New York Heart Association 
O.D. 
Outer diameter 
PCI 
Percutaneous coronary intervention 

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PI 
Principal Investigator 
PTCA 
Percutaneous transluminal coronary angioplasty 
PTFE 
Polytetrafluoroethylene 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
TIMI 
Thrombolysis in myocardial infarction 
UADE 
Unanticipated (serious) adverse device effect 
ULN 
Upper limit of normal 
2.0 
INTRODUCTION 
Chronic total occlusions (CTO) are complex lesions that are relatively common in patients 
undergoing coronary angioplasty (Patel 2013) and present a challenge in achieving total 
coronary revascularization (Christofferson 2005; Fefer 2012). CTOs are defined as complete 
occlusions of a coronary vessel evolving for more than three months (Stone 2005). Current 
treatment options include bypass surgery, percutaneous revascularization, or continued medical 
therapy alone (Fefer 2012), and it has been shown that incomplete revascularization is 
associated with negative long-term clinical outcomes (Farooq 2013).   
Studies have shown the prevalence of CTOs to range from 18-52% in patients with coronary 
artery disease (CAD) undergoing coronary angiogram, depending on the definition used for 
CAD (> 50% vs. ≥ 70% vessel diameter stenosis) (Christofferson 2005; Fefer 2012). Despite the 
prevalence of CTOs, a significant portion go untreated, which highlights the complexity of the 
treatment and the perception of increased risk by operators (Fefer 2012; Christofferson 2005; 
Grantham 2009). Historical technical success rates range from 60-70% with the antegrade 
approach (Joyal 2010), however recent improvements in technology and procedural techniques 
have increased successful procedure rates (Joyal 2010). Innovative guidewire methods 
including retrograde and dissection re-entry techniques have become essential complements to 
the traditional antegrade approach (Joyal 2012). 
Benefits from successful CTO revascularization include alleviation of symptoms, avoidance of 
coronary artery bypass graft (CABG) surgery, improved left ventricular function, and potentially 
better survival rates. For a CTO to be successfully treated, there needs to be technical success 
and an absence of complications (Joyal 2010; Grantham 2009). 
Teleflex has developed a series of guidewires and catheters that are being studied under this 
protocol for the intended use of facilitating the safe and effective crossing of de novo CTOs and 
placement of conventional guidewires beyond the lesion via either a true lumen or subintimal 
pathway. The Teleflex study devices include the GuideLiner® V3 catheter (hereafter referred to 
as “GuideLiner catheter”), TrapLiner® catheter, Turnpike® catheter, and a series of five coronary 
guidewires (SpectreTM guidewire, R350TM guidewire, RaiderTM guidewire, WarriorTM guidewire, 
and BanditTM guidewire). All study devices are currently 510(k) cleared for non-CTO indications.  

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3.0 
REGULATORY CLASSIFICATION 
All study devices are currently 510(k) cleared for non-CTO indications, as shown in Table 1. 
The data captured in this study will be used to support U.S. Food and Drug Administration 
(FDA) 510(k) clearance for CTO indications. 
Table 1: Study Device Regulatory Clearance 
Study Device 
510(k) Number 
Clearance Date 
GuideLiner catheter 
K172090 
10/20/17 
TrapLiner catheter 
K180088, K161901 
4/4/18, 2/3/17 
Turnpike catheter 
K151981, K142065 
8/13/15, 11/25/14 
Spectre guidewire 
K163444 
1/6/17 
R350 guidewire 
K151234 
11/18/15 
Raider guidewire 
K173532 
12/15/17 
Warrior guidewire 
K180128 
2/16/18 
Bandit guidewire 
K181647 
7/20/18 
4.0 
TREATMENT DESCRIPTION 
4.1 
Device Description 
The Teleflex study devices include the GuideLiner catheter, TrapLiner catheter, Turnpike 
catheter, and a series of five coronary guidewires (Spectre, R350, Raider, Warrior, and Bandit). 
A description of each device is provided below. Investigational Instructions for Use (IFU) are 
provided in Appendices A-H. 
4.1.1 Guide Extension Catheters 
Either the GuideLiner or TrapLiner catheter should be used in all cases in which a guide 
extension catheter is needed; see justification in Section 4.1.4. 
GuideLiner Catheter 
The GuideLiner V3 catheter (Figure 1) is a rapid-exchange guide extension catheter designed 
for use in the coronary and peripheral vasculature. It is available in five sizes – 5F, 5.5F, 6F, 7F, 
and 8F. All sizes of the GuideLiner V3 catheter have a 150 cm working length, consisting of a 
125 cm long stainless steel pushwire shaft followed distally by a 25 cm long full-round, silicone-
wiped guide extension segment. The distal 17 cm of the 125 cm pushwire shaft is covered with 
a semi-circular shaped polymer that meets the proximal end of the full-round guide extension 
segment. The GuideLiner V3 catheter has two platinum-iridium marker bands; the distal marker 
band is located at the distal tip and the proximal marker band is located near the collar. The 
GuideLiner V3 catheter also has two positioning marks located 95 cm (single mark) and 105 cm 
(double mark) from the distal tip.  

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Figure 1: GuideLiner Catheter 
 
TrapLiner Catheter 
The TrapLiner catheter (Figure 2) is a rapid-exchange guide extension catheter with a trapping 
balloon on the distal end of the pushrod. It is available in 6F, 7F, and 8F sizes. The stainless-
steel pushrod is covered on the distal end by a semi-circular polymer (“half-pipe”) and 
transitions to a hydrophilic coated full-round polymer guide extension section. There are two 
radiopaque marker bands on the guide extension segment, one on the distal tip and one on the 
collar. The trapping balloon is located proximal to the half-pipe and has a single radiopaque gold 
marker under the proximal end of the balloon. 
Figure 2: TrapLiner Catheter 
 
 
4.1.2 Turnpike Catheter 
At least one model of the Turnpike catheter must be used in each procedure; see justification in 
Section 4.1.4. 
The Turnpike catheter is single lumen and designed for use in the coronary and/or peripheral 
vasculature. The catheter shaft is constructed with an outer polymer layer that encapsulates a 
braid and a dual-layer coil. The distal 60 cm of each catheter has a hydrophilic coating.  
The Turnpike catheter is available in four design versions (Figure 3):  
• 
Turnpike catheter (long, flexible, radiopaque distal tip): Model 5642 and 5643 

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• 
Turnpike LP catheter (lower profile & increased flexibility): Model 5638 and 5639 
• 
Turnpike Spiral catheter (adds an outer coil onto the distal shaft for additional 
rotational advancement): Model 5640 and 5641 
• 
Turnpike Gold catheter (outer coil on the distal shaft and a gold-plated, stainless steel, 
threaded distal tip): Model 5621 and 5622.  
Each configuration is available in 135 cm and 150 cm lengths.   
Figure 3: Turnpike Catheters 
Turnpike Catheter 
 
Turnpike Spiral Catheter 
 
Turnpike Gold Catheter 
 
Turnpike LP Catheter 
 
 
4.1.3 Guidewires 
At least one investigational guidewire must be used in each procedure. To ensure adequate 
representation of each guidewire in the study analysis, each of the following four guidewire 
devices should be used in a minimum of 20 subjects: Spectre, Raider, Warrior, and Bandit. The 
R350 guidewire should be used for all retrograde cases for which wire externalization is 
performed. Sites must promptly provide device use data on the applicable electronic case report 
forms (eCRF) after each enrollment so that the Sponsor/CRO can appropriately monitor usage 
throughout the enrollment period. 
Spectre Guidewire 

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The Spectre guidewire is a nitinol and stainless-steel guidewire with a 0.014” diameter and 
straight shapeable tip. It is available in standard (Model 7386) and extended (Model 7387) 
lengths. The distal 25 cm of the guidewire has a spring coil with a 3 cm platinum coil on the 
distal tip that is visible under fluoroscopic methods. The distal 42 cm of the guidewire has a 
hydrophilic coating and the proximal portion has a polytetrafluoroethylene (PTFE) coating. 
Model 7386 has a modified proximal end to allow for guidewire extension. 
Raider Guidewire 
The Raider guidewire is a stainless-steel core guidewire with a maximum outer diameter of 
0.014” and a straight, shapeable tip. It is available in standard and extended lengths. The 
standard length is compatible with a guidewire extension. The distal portion of the guidewire 
includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The 
proximal portion has a PTFE coating. It is available in standard (Model 7448) and extended 
(Model 7449) lengths. 
Warrior Guidewire 
The Warrior guidewire is a 0.014” diameter stainless steel core guidewire with a 0.009” diameter 
tapered distal tip. The distal 20 cm of the guidewire has a spring coil, of which the distal 2.5 cm 
is visible under fluoroscopic methods. The guidewire has a straight shapeable tip with a tip load 
of 14 grams. The distal portion of the guidewire has a hydrophilic coating and the proximal 
portion has a PTFE coating. It is available in standard (Model 7388) and extended (Model 7389) 
lengths. The proximal end of the standard version has a guidewire extension feature 
Bandit Guidewire 
The Bandit guidewire is a 0.014” diameter stainless steel core guidewire with a 0.008” diameter 
tapered distal tip. It is available in standard and extended lengths. The standard length (Model 
7444) is compatible with a guidewire extension. The distal portion of the guidewire includes a 
radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal 
portion has a PTFE coating. It is also available in an extended length (Model 7445).  
R350 Guidewire 
The R350 guidewire (Model 7390) is 350 cm in length with a 0.013” maximum outer diameter 
(O.D) (0.012" nominal O.D.). It is composed of a nitinol alloy mandrel with a straight, radiopaque 
5 cm gold-coated tungsten coil distal tip. The proximal 150 cm of the R350 guidewire has a 
PTFE coating, while the distal 200 cm has a hydrophilic coating. 
4.1.4 Justification for Minimum Number of Device Uses 
CTO patient populations often have different characteristics that cannot be entirely predicted, 
such as overall patient anatomy, lesion complexity, morphology, and calcification; therefore, it 
would not be appropriate to dictate in how many subjects each investigational device will be 
utilized, especially taking into consideration that Investigators will have an entire CTO toolbox at 
their disposal. While investigational devices are one component of the toolbox, other 
commercial devices play different roles and will also be necessary for procedural success.  

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Specifically considering the Turnpike catheter, each model has specific characteristics to 
address challenges presented by a variety of CTOs (e.g., the Turnpike Gold and Spiral 
catheters are generally used in more heavily calcified lesions).  
Due to the different patient characteristics and device characteristics outlined here, minimum 
sample sizes have not been established for the GuideLiner or TrapLiner catheters, individual 
Turnpike catheter models, or the R350 guidewire.  
As an alternative to establishing minimum sample sizes for these study devices, the following 
device use guidelines are provided to ensure adequate representation of each device in the 
study analysis:   
• 
The GuideLiner catheter or TrapLiner catheter should always be used when any guide 
extension is necessary for completion of a study PCI procedure 
• 
At least one model of the Turnpike catheter must be used in all cases 
• 
The R350 guidewire should be used for all retrograde cases for which wire 
externalization is performed   
4.2 
Principle of Operation / Mechanism 
The principles of operation for the study devices are summarized in Table 2 below. 
Table 2: Principles of Operation 
Device Name 
Principles of Operation 
GuideLiner 
catheter 
The GuideLiner catheter is delivered inside a guide catheter and over a guidewire to 
access discrete regions of the coronary and peripheral vasculature. The stiffer 
proximal shaft of the GuideLiner provides pushability of the catheter through tortuous 
vessels and the floppy distal segment extends the working length of the guide 
catheter to facilitate placement of interventional devices in discrete regions of the 
vasculature. 
TrapLiner 
catheter 
The TrapLiner catheter is delivered inside a guide catheter and over a guidewire to 
access discrete regions of the coronary and peripheral vasculature. The stiffer 
proximal shaft of the TrapLiner provides pushability of the catheter through tortuous 
vessels and the floppy distal segment extends the working length of the guide 
catheter to facilitate placement of interventional devices in discrete regions of the 
vasculature. The TrapLiner catheter has a trapping balloon that, when inflated within 
the guide catheter, facilitates exchange of an interventional device while maintaining 
the position of the guidewire within the vasculature. 
Turnpike 
catheter 
The Turnpike catheters are delivered inside a guide catheter and over a guidewire to 
access discrete regions of the coronary and/or peripheral vasculature. They may be 
used to facilitate placement and exchange of guidewires and to subselectively 
infuse/deliver diagnostic and therapeutic agents. 
Guidewires 
Guidewires are advanced through guide catheters and microcatheters to access 
discrete regions of the coronary and peripheral vasculature. 

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4.3 
Indications for Use 
The indications for use for the study devices are shown in Table 3 below.  The data captured in 
this study will be used to support U.S. Food and Drug Administration (FDA) 510(k) clearance for 
CTO indications.  
Table 3: Investigational Indications for Use 
Device Name 
Indications for Use 
GuideLiner catheter 
 
 
GuideLiner catheters are intended to be used in conjunction with guide 
catheters to access discrete regions of the coronary and/or peripheral 
vasculature, to facilitate placement of interventional devices, and to assist 
in crossing de novo coronary chronic total occlusions (CTO). 
 
TrapLiner catheter 
 
 
The TrapLiner catheter is intended for use in conjunction with guide 
catheters to access discrete regions of the coronary and/or peripheral 
vasculature, to facilitate placement of interventional devices, to facilitate 
the exchange of an interventional device while maintaining the position of 
a guidewire within the vasculature, and to assist in crossing de novo 
coronary chronic total occlusions (CTO). 
 
Turnpike catheter 
 
 
The Turnpike catheters are intended to be used to access discrete 
regions of the coronary and/or peripheral vasculature. They may be used 
to facilitate placement and exchange of guidewires, to subselectively 
infuse/deliver diagnostic and therapeutic agents, and to assist in crossing 
de novo coronary chronic total occlusions (CTO).  
Guidewires 
 
 
The Teleflex guidewires are intended for use in percutaneous procedures 
to introduce and position catheters and other interventional devices within 
the coronary and peripheral vasculature, including use in crossing or 
assisting in crossing de novo coronary chronic total occlusions (CTO). 
Investigational IFUs are provided in Appendices A-H. 
5.0 
 OBJECTIVE  
The objective of this study is to evaluate angiographic confirmation of placement of any 
guidewire beyond the CTO, in the true vessel lumen, in patients undergoing CTO percutaneous 
coronary intervention (PCI) in which at least one Teleflex guidewire and at least one Turnpike 
catheter are used. The data captured in this study will be used to support U.S. Food and Drug 
Administration (FDA) 510(k) clearance for CTO indications. 
6.0 
STUDY POPULATION 
The population for this study is subjects with signs and/or symptoms considered typical of 
ischemic heart disease attributed to a de novo CTO (see section 14.0 for definition) in a native 
coronary artery who are suitable candidates for a percutaneous revascularization. 

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7.0 
ENDPOINTS 
7.1 
Primary Endpoint 
The primary endpoint for the study is procedure success through discharge or 24 hours post-
procedure, whichever comes first. Procedure success is defined as angiographic visualization of 
any guidewire in a position either distal or proximal to the occlusion depending on the route of 
access and the absence of in-hospital major adverse cardiac events (MACE; defined in section 
14.0).  
7.2 
Secondary Endpoints 
The secondary endpoints for the study are:  
• 
Frequency of successful recanalization (defined as angiographic confirmation of 
crossing the chronic total occlusion and restoring blood flow to the affected area). 
• 
Frequency of MACE through discharge or 24 hours post-procedure, whichever comes 
first (in-hospital), and at 30 days post-procedure (see section 14.0 for MACE definition). 
The components of MACE will also be reported separately. 
• 
Frequency of clinically significant perforation (defined as any perforation resulting in 
hemodynamic instability and/or requiring intervention including pericardiocentesis, 
embolization, prolonged balloon occlusion, stent graft, or comparable therapy). 
• 
Procedural success according to crossing technique. 
• 
Technical success (see section 14.0 for definition). 
7.3 
Statistical Methods 
7.3.1 Analysis Datasets 
All analyses will be conducted under the principles of intent-to-treat, using the full analysis set 
(FAS) as defined in ICH E9 (Statistical Principles for Clinical Trials). Primary analyses will 
include all available data on all enrolled subjects. 
7.3.2 General Principles 
Standard summary statistics will be calculated and reported; for continuous variables, statistics 
will include means, standard deviations, medians and ranges or interquartile ranges. 
Categorical variables will be summarized in frequency distributions. 
All statistical analyses will be performed using SAS (version 9.4 or higher, SAS Institute Inc. 
Cary, NC), R (version 3.2 or higher, R Foundation for Statistical Computing, Vienna, Austria) or 
other widely accepted statistical or graphical software. 
7.3.3 Analysis of Primary Endpoint 
The primary endpoint is procedure success through discharge or 24 hours post-procedure, 
whichever comes first.  This endpoint will be assessed for each enrolled subject and presented 
as a proportion of successes with corresponding confidence limits calculated via the exact 

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binomial method. Note that enrollment occurs when an investigational guidewire has entered 
the guide catheter. 
Results will then be compared to a performance goal derived from the literature on comparable 
products in the intended study population. Formally, the hypotheses to be tested are as follows: 
H0: µ ≤ PG 
HA: µ > PG, 
where µ is the proportion of successes and PG is the performance goal. The hypotheses will be 
tested at a one-sided alpha level of 0.05 and study success will be declared if the performance 
goal is met (i.e., if the null hypothesis above is rejected in favor of the alternative hypothesis). 
The performance goal (PG) is derived from the literature on CTO crossing using similar 
endpoints and populations. Specific references and resulting analysis are as follows: 
Study 
Procedural Success 
% (n/N) 
95% confidence 
interval 
Olivari (2003) 
73.3% (286/390) 
(68.6%, 77.7%) 
Prasad (2007) 
69.7% (879/1262) 
(67.0%, 72.2%) 
Valenti (2008) 
70.8% (344/486) 
(66.5%, 74.8%) 
Kandzari (2015) 
79.0% (109/138) 
(71.2%, 85.5%) 
Kandzari (2018) 
73.0% (119/163) 
(66.2%, 79.8%) 
Meta-analyzed rate 
73.2% 
 
The meta-analyzed rate is derived from study-level pooling incorporating the five studies, with a 
resulting success rate of 73.2%. Incorporating a 10% statistical delta for hypothesis testing 
purposes, the performance goal for the primary endpoint is therefore PG = 63.2%. 
7.3.4 Analysis of Secondary Endpoints 
Secondary endpoints will be summarized and tabulated without formal hypothesis testing 
according to the general principles in section 7.3.2 above. 
7.3.5 Safety Analysis 
Summary tables and listings will be provided for all reported adverse events, which will 
additionally be reported by seriousness and relatedness. Such summaries will be comprised of 
the number and percentage of subjects with an adverse event and the total number of such 
events. The proportion of subjects with events will be considered primary for analysis of adverse 
events. 
7.3.6 Sample Size 
The postulated success rate for the primary endpoint is estimated to be 73.2%, based on the 
literature references cited above; the performance goal of 63.2% is as previously defined. Given 
a one-sided test at 0.05 alpha and desired power of 80%, the required evaluable sample size is 
135. A study sample size of 150 total subjects therefore provides adequate powering for 
hypothesis testing as described in section 7.3.3 above. 

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7.4 
Statistical Analysis Plan 
Refer to the separate Statistical Analysis Plan (SAP) for additional details on statistical design, 
method and analytical procedures. Any departure or deviation from these planned statistical 
methodologies will be documented and will include the statistical rationale for divergence. 
8.0 
STUDY DESIGN 
8.1 
Overall Design 
The investigation is a prospective, multicenter, single-arm, intent-to-treat, literature-controlled 
clinical study.  
8.2 
Number of Sites & Subjects 
The study will be conducted in up to 15 investigational sites in the U.S. This study will enroll up 
to 150 patients to provide adequate powering for hypothesis testing and an evaluable sample 
size of at least 135 patients. The study Sponsor and CRO will manage sites so that no single 
site enrolls more than approximately 20% of the total study enrollment. 
8.3 
Study Duration 
Enrollment is expected to take approximately 12 – 18 months. Each study subject will actively 
participate in the study through hospital discharge. The overall study duration, from IRB 
approvals, first patient screening, to the final follow-up visit, data analysis and final report, is 
expected to be approximately 18 – 24 months. 
8.4 
Subject Eligibility Criteria 
Eligible subjects have signs and/or symptoms considered typical of ischemic heart disease 
attributed to a de novo CTO (see section 14.0 for definition) in a native coronary artery and are 
suitable candidates for a percutaneous revascularization. 
8.4.1 Inclusion Criteria 
Subjects must meet all of the following inclusion criteria: 
General inclusion criteria 
1. At least 18 years of age at the time of consent 
2. Experiencing clinical symptoms considered suggestive of ischemic heart disease (e.g., chest 
pain or discomfort, heart failure) or has evidence of myocardial ischemia (e.g., abnormal 
functional study) attributed to the CTO target vessel and is scheduled for clinically indicated 
percutaneous revascularization 
3. Subject is eligible and consents to undergo PCI procedure 
4. Acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, 
and emergency CABG 
5. Willing and able to sign a study Informed Consent Form (ICF) approved by a local or central 
Institutional Review Board (IRB) 

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6. Female subjects of childbearing potential must have a negative pregnancy test per standard 
of care for PCI and be practicing contraception 
Angiographic inclusion criteria 
7. A minimum of one de novo lesion with at least one target segment in a native coronary 
vessel meeting the definition of CTO (any non-acute total coronary occlusion fulfilling the 
angiographic characteristics consistent with high-grade native coronary stenosis 
(Thrombolysis in Myocardial Infarction (TIMI) score of 0 or 1) and estimated to be in duration 
of ≥ 3 months by clinical history and/or comparison with antecedent angiogram or 
electrocardiogram) 
8.4.2 Exclusion Criteria 
Subjects must not meet any of the following exclusion criteria: 
General exclusion criteria 
1. History of allergy to iodinated contrast that cannot be effectively managed medically 
2. Evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment 
defined as CK-MB greater than 3 times the upper limit of normal (ULN) 
3. Previous coronary interventional procedure of any kind within 30 days prior to the procedure 
4. Any contraindication to cardiac catheterization or to any of the standard concomitant 
therapies used during routine cardiac catheterization and PCI (e.g., aspirin, clopidogrel, 
unfractionated heparin) 
5. Target lesion requires treatment with another device, after successful crossing with a study 
device, other than PTCA devices prior to stent placement 
6. Atherectomy procedure is planned for the target lesion 
7. Known history of clinically significant abnormal laboratory findings ≤ 14 days prior to 
enrollment, including:  
• 
Neutropenia (<1000 neutrophils/mm3)  
• 
Thrombocytopenia (<100,000 platelets/mm3) 
• 
AST, ALT, alkaline phosphatase, or bilirubin > 1.5 × ULN 
• 
Serum creatinine >2.0 mg/dL 
8. Evidence of current clinical instability including the following: 
• 
Sustained systolic blood pressure <100 mmHg or cardiogenic shock 
• 
Acute pulmonary edema or severe congestive heart failure (CHF). Severe CHF is 
defined as NYHA Class IV. 
• 
Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade 
• 
Suspected dissecting aortic aneurysm 
• 
Hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, 
restrictive cardiomyopathy, or congenital heart disease 
9. History of stroke or transient ischemic attack within 6 months prior to procedure 

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10. Active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to procedure 
11. History of bleeding diathesis or coagulopathy or refusal of blood transfusions 
12. Other pathology such as cancer, known mental illness, etc., which might, in the opinion of 
the Investigator, put the patient at risk or confound the results of the study 
13. Unable or unwilling to comply with the protocol 
14. Currently participating in an investigational drug or device study that has not completed the 
primary endpoint or that clinically interferes with the current study endpoints; or requires 
coronary angiography, intravascular ultrasound, or other coronary artery imaging 
procedures 
Angiographic exclusion criteria 
15. Occlusion involves segment within previous stent (“in-stent occlusions”) 
16. Extensive lesion-related thrombus (TIMI thrombus grade 3 or 4) 
17. Previous stenting (drug-eluting or bare metal) in the target vessel unless the following 
conditions are met: 
• 
It has been at least 9 months since the previous stenting 
• 
Target lesion is ≥15 mm away from the previously placed stent 
• 
Previously stented segment (stent plus 5 mm on either side) has no more than 40% 
diameter stenosis, based on visual estimate 
18. Target vessel has other lesions proximal to the total occlusion identified with > 75% 
diameter stenosis based on visual estimate; exception: planned stenting of a lesion proximal 
to the target lesion that can be covered by a single stent (i.e., tandem lesions) is acceptable 
9.0 
STUDY METHODOLOGY 
9.1 
Study Summary & Schema 
Figure 4 summarizes the sequence of study assessments, procedures, and activities. 

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Figure 4: Study Flow Diagram 
 
 

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9.2 
Screening 
Screening is defined as the process of reviewing a patient’s medical records against the study 
eligibility (non-angiographic inclusion and exclusion) criteria to determine if the patient is 
potentially eligible to enroll in the study. It is expected that the medical records will contain 
adequate information to determine if a patient meets most of these criteria. If the Investigator (or 
designee) determines the patient meets all non-angiographic inclusion criteria and no non-
angiograph exclusion criteria (except criteria verified by blood testing after consent), they can be 
consented for study participation, after which all remaining non-angiographic eligibility criteria 
will be verified prior to the procedure. If any criteria are not met prior to the procedure, the 
patient will be considered a screen failure and will be tracked on the Screen Failure Log. 
Angiographic eligibility criteria will be verified at the time of procedure. If any angiographic 
eligibility criteria are not met, the patient will be considered a screen failure and recorded as 
such on the Screen Failure Log. 
9.3 
Informed Consent 
Prior to enrolling patients in this study, the site will be required to have an Institutional Review 
Board (IRB) approved informed consent form (ICF). The contract research organization (CRO) 
must approve any modifications made to the Sponsor’s template ICF prior to IRB submission. 
Written informed consent will be obtained from the patient prior to the subject’s participation in 
the study. The Investigator (or authorized designee) will explain the nature of the planned 
treatment and objectives of the study to the patient, allowing adequate time for the patient to 
read and review the consent form and to ask questions. The patient and the Investigator (or 
authorized designee) will sign and date the ICF.   
The site will retain the original signed ICF in the subject’s study records and will provide a copy 
of the signed ICF to the subject. The site will document the consent process (e.g., that the 
subject was consented, the date on which the consent was obtained, and that a copy of the 
signed ICF was given to the subject) in the subject’s medical records.  
Subjects will be informed of any new information that may make him/her change their mind 
about staying in the study. Subjects may be asked to sign a new ICF if this occurs. 
9.3.1 Vulnerable Population 
Sponsor is not anticipating enrollment of a vulnerable patient population (ref. ISO 14155:2011 
section A.15). 
9.4 
Point of Enrollment & Numbering of Study Subjects 
A patient will be considered enrolled as a study subject once an investigational guidewire has 
entered the guide catheter.  
The site staff assigns the lowest available subject number progressing sequentially for each 
enrolled subject (e.g., 001, 002, 003). As soon as possible after a subject is enrolled, a member 
of the site’s study team will notify the CRO, preferably by an entry in the database (EDC) or via 
email notification. 

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9.5 
Schedule of Visits & Testing Requirements 
Table 4 outlines the visits, visit windows, and testing requirements at each evaluation time point.  
Table 4: Visits & Testing Requirements 
Testing & Data Collection 
Screening / 
Baseline 
PCI Procedure 
 
(Within 30 days 
of Screening 
Assessment) 
6-12 Hrs. 
Post-
procedure 
Discharge 
OR 
18-24 Hrs. 
Post-procedure 
(whichever 
comes first) 
30 days (± 7 
days) 
Inclusion and exclusion criteria 
√ 
 
 
 
 
Informed consent  
√ 
 
 
 
 
Demographics 
√ 
 
 
 
 
Medical & surgical history  
(within 14 days of procedure) 
√ 
 
 
 
 
Cardiac medication review  
√ 
√ 
 
√ 
√ 
Pregnancy test  
(if female of child-bearing potential) 
√ 
 
 
 
 
Blood test (total CK and CK-MB) 
√1 
 
√ 
√ 
 
Angiogram (pre- and post-PCI) 
 
√  
 
 
 
PCI procedure 
 
√ 
 
 
 
Adverse event monitoring 
 
√ 
√ 
√ 
√ 
Device deficiency assessment 
 
√ 
 
 
 
1 Must be obtained within 72 hours of the procedure. 
 
9.6 
Subject Assessments & Study Procedures 
Note: See Section 14.0 for definitions of endpoint-related terms used in this section. 
9.6.1 Baseline 
The following standard of care evaluations and assessments will be performed at baseline: 
• 
Demographics 
• 
Medical and surgical history obtained within 14 days of the procedure (to include any 
previous catheterizations, vascular procedures/surgery, and concomitant diseases) 
• 
Cardiac medication review (see Section 14.0) 
• 
Blood test: Venous blood will be obtained for laboratory analysis; tests will include 
cardiac enzymes (total CK and CK-MB). Blood test results must be obtained within 
72 hours of the procedure 
• 
Pregnancy test (if female and of childbearing potential), per standard of care for PCI 
After the baseline evaluations, the inclusion and exclusion criteria should be re-reviewed to 
ensure that the subject continues to be eligible for the study.  

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9.6.2 Pre-PCI Procedure Angiogram 
Selection criteria for access approach (femoral or radial artery) will be at the discretion of the 
Investigator and will be based on a variety of clinical factors such as patient anatomy, 
vasculature, and other possible comorbidities.   
Standard catheterization and angiographic procedures will be followed during this study and any 
adverse events that occur during and after the procedure will be collected. A pre-procedure 
angiogram of the target vessel will be completed per the Angiographic Core Laboratory 
Guidelines prior to any interventions on the CTO. Assessment of angiographic eligibility is 
based on a visual assessment of the pre-procedure angiogram.  
9.6.3 PCI Procedure 
The PCI procedure will be performed with the study device(s) following these guidelines: 
• 
At least one Teleflex guidewire and at least one Turnpike catheter must be used during 
a study PCI procedure 
• 
The R350 guidewire should be used for all retrograde cases for which wire 
externalization is performed.   
• 
The GuideLiner catheter or TrapLiner catheter should be used when any guide 
extension is necessary for completion of a study PCI procedure 
• 
Additional study devices and commercially available guidewires and catheters may be 
used during a study PCI procedure at the discretion of the physician 
Post-procedure angiographic imaging of the CTO must be captured and performed per the 
instructions provided by the core laboratory and must be captured in a precise manner as was 
used for the pre-procedure images. Angiographic images of the CTO must be sent to the core 
lab per specified method. 
If the subject is returned to the procedure room and a guiding catheter is reinserted and a 
dilatation is performed, this will be considered a repeat intervention. 
Standard PCI procedural data will be collected on the CRFs such as: 
• 
Vessel and lesion characteristics  
• 
TIMI grade flow pre and post treatment 
• 
Approach technique(s) 
• 
Type and size of devices used 
• 
The order in which guidewires were used and which guidewire was the crossing 
guidewire 
• 
Procedural durations including start/end times 
• 
Air Kerma (Gy) and total fluoroscopy time 
• 
Procedure-related medications 
• 
Adverse event assessment including perforation and dissection classifications 
• 
Device deficiency assessment 

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See Section 14.0 for procedure-related definitions and Table 5 below for recommendations for 
procedure-related medications. 
Table 5: Procedure-Related Medications Recommendations 
Timepoint 
Medication Recommendations 
Pre-procedure 
1. Aspirin: 100-325 mg non-enteric coated aspirin orally at least one hour and 
no more than 23 hours prior to procedure, or per hospital protocol. 
2. Clopidogrel: 300 mg loading dose the day before the procedure or 600 mg 
the day of the procedure or sufficient existing steady state blood 
concentration, or per hospital protocol. If the patient had been taking 
Clopidogrel (75 mg/day) for three or more consecutive days prior to the 
procedure, the loading dose need not be given. 
Note: The use of glycoprotein IIb/IIIa inhibitors is not recommended. 
Peri-procedure 
• 
Heparin dose as required to maintain an activated clotting time (ACT)>250 
seconds. 
Post-procedure 
• 
Aspirin: 100-325 mg administered daily, or per hospital protocol; AND 
• 
Clopidogrel: 75 mg by mouth daily or per hospital protocol; OR 
• 
Ticagrelor: 90 mg twice daily or per hospital protocol; OR 
• 
Prasugrel: 10 mg daily (5 mg if >75 years old or <60 kg weight), or per 
hospital protocol. 
Note: the use of glycoprotein IIb/IIIa inhibitors is not recommended. 
9.6.4 6 – 12 Hours Post-Procedure  
The following evaluations and assessments will be performed: 
1. Blood test: total CK and CK-MB 
2. Adverse event assessment  
If CK-MB is > 3x the upper limit of normal (ULN), a series of CK-MB measurements may be 
performed per institutional standards starting from when the first elevation is noted. All CK and 
CK-MB values will be recorded on the appropriate eCRF. 
9.6.5 18 – 24 Hours Post-Procedure / Discharge 
The following evaluations and assessments will be performed at 18-24 hours post-procedure or 
directly prior to discharge, whichever occurs first: 
1. Cardiac medication review (refer to section 14.0 for definition) 
2. Blood test: total CK and CK-MB 
3. Adverse event assessment  
If CK-MB is > 3x the upper limit of normal (ULN), a series of CK-MB measurements may be 
performed per institutional standards starting from when the first elevation is noted. All CK and 
CK-MB values will be recorded on the appropriate eCRF. 

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9.6.6 Thirty (30) Days Post-Procedure 
The following evaluations and assessments will be performed at 30 days (±7 days) post-
procedure via phone call and/or clinic visit and consist of: 
1. Cardiac medication review (refer to section 14.0 for definition) 
2. Adverse event assessment  
At the conclusion of this follow-up subjects will exit from this study via completion of the Study 
Completion eCRF. Subjects will continue to be followed by their physician per usual care. 
9.6.7 Early Withdrawal/Premature Discontinuation of Subjects 
Subjects may be withdrawn early from the study for several reasons including: 
• 
Subject death 
• 
Subject request for withdrawal (withdrawal of consent) 
• 
Investigator decision, to be fully documented 
• 
Safety reasons, as determined by Investigator, CEC, or FDA 
If a subject is discontinued from the study early, a Study Completion eCRF must be completed 
describing the reason for early discontinuation. If a subject chooses to withdraw from the study 
and withdraws consent for disclosure of future information, no further evaluation(s) should be 
performed, and no additional data will be collected. The Sponsor may retain and continue to use 
any data collected prior to the withdrawal of consent. 
10.0 MEASURES TO AVOID & MINIMIZE BIAS 
The study has several measures that have been implemented to avoid and minimize bias 
including: 
• 
Use of an independent CRO for study operations management, monitoring, and data 
management. 
• 
Establishment of a Clinical Events Committee to independently review and adjudicate 
adverse events. 
• 
Use of an independent angiographic core laboratory for systematic review of images 
removing any potential for Investigator bias. 
10.1 
Clinical Events Committee  
All adverse events will be arbitrated by the Clinical Events Committee (CEC). The CEC, which is 
made up of at least two interventional cardiologists who are not Investigators in the study, will 
adjudicate and classify adverse events for seriousness, and device and/or procedure 
relationship following written CEC Adjudication Guidelines. Sites will be expected to provide 
supporting de-identified source documentation as requested to assist CEC adjudication.  

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10.2 
Angiographic Core Laboratory 
An angiographic core laboratory will be used to provide an unbiased assessment of 
angiographic imaging. The angiographic core laboratory will provide image acquisition and 
processing instructions to the sites. The angiographic core laboratory will follow its own Charter 
or similar procedure to systematize their image review in compliance with the study protocol. 
11.0 ADVERSE EVENTS 
11.1 
Adverse Event Definitions 
Refer to Section 14.0 for adverse event definitions. 
The following are not considered adverse events for this study: 
• 
Any condition that is recorded as pre-existing on the Baseline CRF, unless there is a 
worsening of that condition in terms of nature, severity, or degree of incidence.   
• 
Any normal expected symptoms associated with PCI unless the event involves a 
clinically significant change in severity or duration of symptoms or requires clinical 
intervention that is different from ordinary postoperative care. The following are 
examples of the normal responses to all PCI procedures and are not considered AEs:  
• 
Transient arterial spasm resolving spontaneously OR with medication only 
• 
Transient sinus bradycardia with heart rate ≤ 50 bpm, with no hemodynamic impact, 
and resolving spontaneously (Prophylactic placement and automatic activation of a 
cardiac pacer during this transient period does not constitute an intervention) 
• 
Minor discomfort or bruise at the arterial access place 
• 
Small amount of bleeding at point of arterial access that does not result in a 
hematoma > 5 cm, need for transfusion, or hemodynamic compromise 
• 
Side effects of standard-of-care medications 
11.2 
Adverse Event Collection & Documentation 
Collection of adverse events will start when subjects are enrolled and will be assessed and 
reported throughout the study. Investigators must obtain all information available to determine 
the causality and outcome of the adverse event and to assess whether it meets the criteria for 
classification as a related serious adverse event requiring immediate notification. All adverse 
events will be followed until resolution or Investigator determination that the subject’s condition 
is stable. 
All reported adverse events will be documented on the Adverse Event CRF. Copies of de-
identified source documentation that contain significant information related to the event, such as 
progress notes, consultations, nurse’s notes, operative reports and subject summaries, etc. may 
be requested by the Sponsor, CRO, CEC and/or angiographic core lab as needed for evaluation 
and adjudication.  

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Device deficiencies will also be collected. If a device deficiency results in the subject 
experiencing any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs, these outcomes will be reported as an adverse event on an Adverse Event CRF. 
Any malfunctioning devices will be returned to the Sponsor by the Site for further evaluation. 
In case of subject death, it is requested that a copy of the death certificate and a copy of the 
autopsy report, if applicable, be sent to the CRO. Any other source documents related to the 
death should also be provided to the CRO. If no source documents are available, the PI is 
required to describe the circumstances of the subject’s death in written communication (e.g., 
letter, e-mail). 
11.3 
Adverse Event Reporting Timeframes 
The Investigator is responsible for reporting serious adverse events to the IRB in accordance 
with the IRB’s procedures. Unanticipated adverse device effects (UADEs) have special 
reporting requirements for both the Investigator and Sponsor, as described in 21CFR812.150: 
• 
Investigator Report: If a subject experiences a UADE, the Investigator must notify the 
Sponsor and the reviewing IRB as soon as possible, but no later than 10 working days 
after the Investigator first learns of the effect. 
• 
Sponsor Report: UADEs will be reported to the Food and Drug Administration (FDA), 
all reviewing IRBs, and participating Investigators as soon as possible, but no later than 
10 working days after receiving notice of the UADE. 
Sites will also follow regulations for reporting serious device-related injury and/or deaths by way 
of the MedWatch process (Medical Device Reporting [MDR] for Device User Facilities for FDA 
approved/cleared product). The FDA and Sponsor understand that FDA may receive duplicate 
reports of serious potentially related adverse events due to the clinical trial data collection 
process and the duplicate MDR reporting process. The FDA and Sponsor also understand that 
event information may be reported via the MDR process prior to Sponsor event monitoring and 
CEC adjudication. 
11.4 
Adverse Event Relationship 
The Investigator and the CEC will assess the relationship of the adverse event to the device 
treatment or procedure as follows: 
• 
Definitely: The adverse event follows a strong temporal sequence to the receipt (or 
attempted receipt) of the device treatment or procedure. This can include an adverse 
event that occurs after the study procedure.  
• 
Probably: The adverse event follows a reasonable temporal sequence to the receipt (or 
attempted receipt) of the device treatment or procedure, and the possibilities of other 
factors, such as underlying and concomitant illness, concomitant medications, or 
concurrent treatment can be excluded. 
• 
Possibly: The adverse event follows a reasonable temporal sequence from receipt (or 
attempted receipt) of the device treatment or procedure and the possibility of device 

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treatment or procedure involvement cannot be excluded. However, other factors such as 
underlying or concomitant illness, concomitant medications, or concurrent treatment are 
presumable. 
• 
Unlikely: The adverse event has an improbable temporal sequence to the receipt (or 
attempted receipt) of the device treatment or procedure, or it can be reasonably 
explained by other factors, including underlying or concomitant illness, concomitant 
medications, or concurrent treatment. 
• 
Not Related: The adverse event has no temporal sequence to the interventional 
procedure, the device treatment, or any user handling, or it can be explained by other 
factors, including underlying disease or concomitant illness, concomitant medication, or 
concurrent treatment. 
Adverse events adjudicated by the CEC as definitely or probably will be considered related 
adverse events for data analytic purposes. Events adjudicated by the CEC as possibly, unlikely 
or not related will not be considered related adverse events for data analytic purposes.  
All reported major cardiac adverse events, regardless of relationship, will result in a procedure 
failure for data analytic purposes. Refer to Section 14.0 for definitions of MACE and procedure 
success.   
12.0 RISK/BENEFIT ANALYSIS 
12.1 
Potential Benefits of Study Participation 
There are no guaranteed benefits from participation in this study; however, it is possible that 
treatment with a study device may have the following benefits: 
• 
Potentially lower-risk catheter-based revascularization of a coronary artery that may 
otherwise require surgical intervention via CABG 
• 
Reduction in symptoms of CAD 
• 
Improvement in quality of life 
12.2 
Alternative Treatment 
There is no obligation for a patient to take part in this study. Alternative treatments may include: 
• 
Surgical intervention via CABG 
• 
Interventional procedure using commercially available CTO devices (e.g., Boston 
Scientific CrossBoss Catheter, Stingray LP catheter and Stingray Guidewire; Boston 
Scientific TruePath CTO Device; Asahi guidewires and/or Corsair microcatheter) 
12.3 
Potential Risks Associated with Study Participation 
As with any surgical procedure, use of the study devices during PCI involves some risks. The 
potential risks or discomforts listed below may be associated with the study devices. Risks 
associated with the PCI procedure will be listed in the Site’s procedure consent form used per 

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their standard of care. The list below includes possible risks associated with the use of the study 
devices in a CTO population.  
The frequency and severity of adverse events can vary, and may necessitate additional medical 
intervention, including surgery. 
Bleeding 
Cardiac arrest 
Cardiac tamponade 
CVA / stroke 
Death 
Embolism 
Hematoma 
Hypertension 
Hypotension 
Infection 
Inflammatory response 
Myocardial infarction 
Pericardial effusion 
Septal hematoma 
Slow-flow / occlusion 
Stent dislodgement 
Tachycardia 
Thrombosis 
Vessel dissection 
Vessel perforation 
Vessel rupture 
Vessel spasm 
Additional possible risks from the evaluations required during this study (but not directly related 
to the use of the study devices) include:  
Laboratory Testing Risks: 
For blood tests, a sample will be taken by inserting a needle into a vein in the arm. Some risks 
of this procedure include fainting, infection, bruising, formation of a blood clot, pain, and/or 
bleeding at the site of the needle puncture. 
12.4 
Methods to Minimize Risks 
A risk analysis has been conducted and risks have been minimized through appropriate design 
control and confirmed by pre-clinical bench and laboratory testing. 
To mitigate the risks above, Teleflex will work with interventional cardiologists trained 
specifically in CTO revascularization techniques, train all study personnel, and provide device 
labeling that contains all appropriate information to treat the patient.  
12.5 
Risk-to-Benefit Rationale 
The results from the risk analysis and risk mitigation measures, combined with commercial 
experience with study devices, support reasonable assurance of the safety and efficacy of the 
Teleflex study devices. The evidence supporting the safety and effectiveness of the Teleflex 
study devices is also based on a foundation of CTO PCI clinical investigations (reference Asahi 
Intecc NCT02379923; Kandzari 2018) and seven years of market experience with similar 
market-released CTO products (reference BridgePoint Medical System [now Boston Scientific] 
CrossBoss/Stingray K102725 (2011)). The evidence supports a clinical benefit to risk 
determination that is favorable for the Teleflex study devices. 

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13.0 ADMINISTRATIVE PROCEDURES 
13.1 
Records & Reports 
13.1.1 Case Report Forms 
A clinical trial database, commonly referred to as an electronic data capture (EDC) system will 
be used to collect study-required data on eCRFs. The Principal Investigator (PI) at the site is 
responsible for ensuring the eCRFs are accurate and completed in a reasonable timeframe. The 
PI is required to review and approve the eCRF on the appropriate page(s) to verify the 
completeness, accuracy, and authenticity of the recorded data.  
13.1.2 Sponsor / CRO Study Records 
The Sponsor and CRO are responsible for maintaining study records and reports per applicable 
ICH Good Clinical Practices (GCP), FDA regulations, ISO 14155, and applicable standard 
operating procedures and study specific-plans (e.g., Monitoring Plan, Data Management Plan, 
Training Plan, and Statistical Analysis Plan). 
13.1.3 Investigator Study Records 
The Investigator will maintain the following accurate, complete, and current records relating to 
their participation in the study as follows: 
• 
All significant correspondence that pertains to the investigation. 
• 
Records of each subject’s case history and exposure to the investigational device. Case 
histories include the CRFs and supporting data including, for example, signed and 
dated ICFs and medical records including, for example, progress notes of the physician, 
the individual’s hospital chart(s), and the nurses’ notes. Such records will include: 
• 
Documents evidencing the informed consent process. The case history of each 
individual will document that informed consent was obtained at the appropriate time. 
• 
All relevant observations, including records concerning adverse device effects 
(whether anticipate or unanticipated), information and data on the condition of each 
subject upon entering, and during the course of, the investigation, including 
information about relevant previous medical history and the results of all diagnostic 
tests. 
• 
A record of the exposure of each subject to the investigational device, including the 
date and time of each use, and any other therapy.  
• 
The protocol, with documents showing the dates and reasons for each deviation from 
the protocol.  
• 
Signed Investigator Agreements, financial disclosure agreements, Investigator signature 
pages from the protocol, and curriculum vitae (CV). 
• 
IRB approval documents including approval of the protocol, protocol amendments and 
ICF. 
13.1.4 Investigator Reporting Requirements 
Investigator reporting requirements are noted in Table 6 below. 

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Table 6: Investigator Reporting Requirements  
Report 
Submitted To 
Description 
Unanticipated Adverse 
Device Effects (UADE) 
Sponsor/ CRO 
& IRB 
Notification within 10 working days after the Investigator 
first learns of the effect. 
Device deficiency that 
might have led to a 
serious adverse event if 
appropriate action had 
not been taken, 
intervention had not 
occurred, or 
circumstances had 
been less fortunate 
Sponsor/ 
CRO 
Notification within 5 working days after the Investigator 
first learns of the device deficiency that might have led to 
an SAE. 
Serious Adverse 
Events (SAE) 
IRB 
Per IRB reporting requirements. 
Withdrawal of IRB 
approval 
Sponsor/ CRO 
Notification within 5 working days of withdrawal. 
Progress Report 
Sponsor/ CRO 
& IRB 
Periodic report detailing the progress of the study, 
occurring at least annually. 
Deviations from 
protocol (CFR 812.150) 
 
 
 
 
Sponsor/ CRO 
& IRB 
Emergency Use: Notification must be made within 5 
working days of the occurrence of an emergency 
deviation (made to protect the life or physical well-being 
of a subject). 
Other: If the deviation affects scientific soundness of the 
study or the rights, safety, or welfare of the subject (and 
is not an emergency), prior approval must be obtained 
from Sponsor the reviewing IRB, and FDA when 
required. 
Failure to obtain 
informed consent 
Sponsor/ CRO 
& IRB 
Notification within 5 working days.  
Final Report 
Sponsor/ CRO 
& IRB 
Submitted within 3 months after termination or 
completion of the investigation. 
 
13.1.5 Record Storage & Retention 
Refer to Clinical Research Agreement for trial data storage, access, and retention requirements. 
13.2 
Data Management 
Correction of missing or unclear data will be requested as necessary throughout the study. The 
CRO may request additional information including source documentation as needed. The CRO 
will also be responsible for confirming the overall integrity of the data. Refer to the study-specific 
Data Management Plan for more details. 
13.3 
Device Accountability 
All Teleflex study devices are FDA 510(k)-cleared and are being studied in this protocol for 
potential expanded indications. Because each of these devices are commercially available, 

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device accountability is not required. The Investigators will be trained to the investigational IFUs 
provided in Appendices A-H.  
All commercial devices are labeled with reference and lot numbers. The specific reference and 
lot numbers will be recorded on the applicable eCRF when the device is used as part of the 
study.  
13.4 
Site Selection 
Potential investigative sites are nominated for inclusion in the study based on their research 
history, expertise in treating CTO lesions, and familiarity with the Teleflex devices. The Sponsor 
and CRO will further assess each potential site to ensure the Investigators and his/her staff 
meet the minimum following criteria: 
• 
The site has an interventional cardiologist that can act as principal Investigator 
• 
The Investigators are qualified by experience and training 
• 
The site has adequate research support staff with the availability to fulfill the clinical 
study requirements specified in the protocol 
• 
The site has adequate access to CTO patients  
• 
The site is not participating in another investigational study that is currently enrolling 
subjects with competing eligibility criteria; studies that have completed enrollment and 
are in the subject follow-up phase would not exclude the site from participation in the 
CTO study 
• 
The Investigators are not on the FDA disqualified or debarred list 
Additional details are specified in the study-specific Site Selection Questionnaires used to select 
eligible sites. 
13.5 
Site Training 
Training of the clinical site personnel will be the responsibility of the study Sponsor and the 
CRO. Site personnel will be trained per the study-specific Training Plan. All site personnel will 
undergo training prior to performing any study-related procedures. All training will be 
documented. Existing site personnel who have been delegated new tasks and new site 
personnel will undergo training as designated in the Training Plan.  
13.6 
Site Monitoring 
This clinical study will be monitored according to a study-specific Monitoring Plan that complies 
with GCP. Monitors will assess for appropriate study conduct and data integrity, including review 
of eCRFs and parity checks with the source documentation, worksheets, and hospital charts. At 
a minimum, the ICF and the ICF process, eligibility criteria, primary and secondary endpoint 
data, and adverse event data will be 100% monitored and compared to source documentation.  

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13.7 
Institutional Review Board (IRB) 
A central or institutional (“local”) IRB will review and approve this study for each participating 
site. The site must submit the protocol and ICF to the IRB and forward a copy of the written 
approval to the CRO. The study identification (study number, protocol title, and version), 
documents approved (e.g., protocol, ICF), and the date of the review should be clearly stated on 
the IRB approval documentation, and the approval must be signed by the IRB. The site will not 
be activated to enroll subjects until a copy of written and dated approval has been received by 
the CRO and other applicable study activation requirements (as outlined in the Monitoring Plan) 
are complete. 
The site must submit any protocol or ICF amendments to the IRB and is required to forward a 
copy of the written approval to the CRO. An IRB approval of the amended document(s) must be 
obtained before implementation and before new subjects are consented to participate in the 
study using the amended ICF, if applicable. The IRB should also be informed of any event likely 
to affect the safety of subjects or the conduct of the study. 
The ICF must be reviewed by the CRO prior to submission to the IRB for approval. 
13.8 
Protocol Deviations 
A protocol deviation is defined as a circumstance in which the Investigator or other site 
personnel did not conduct the trial according to the protocol, applicable laws/regulations, or any 
study agreements (e.g., Clinical Research Agreement or Investigator Agreement).  
Every attempt will be made to adhere to the protocol. However, should an Investigator be 
required to deviate from the protocol to protect the life or physical well-being of a study subject 
in an emergent circumstance, such notice will be given to the Sponsor or CRO as soon as 
possible, but no more than 5 working days from the date the emergency occurred. Except for an 
emergent circumstance, prior approval from the Sponsor and the IRB is required for any change 
in, or deviation from, the protocol as such changes may affect the scientific soundness of the 
protocol or the rights, safety, and welfare of study subjects.  
Protocol deviations will be documented on the Protocol Deviation eCRF. Deviations are 
reportable to the Institution’s governing IRB during the annual reporting process, unless 
otherwise directed by the governing IRB requirements. Repeated serious protocol deviations will 
be closely monitored by the CRO/Sponsor. If excessive deviations or a failure to reduce 
deviations is noted, the Sponsor reserves the right to suspend study enrollment or terminate the 
site from the study until a sufficient system is in place at the site to reduce further deviations (21 
CFR 812.46(a)).  
13.9 
Protocol Amendments 
Changes to the protocol must be documented in a formal protocol amendment prior to 
implementation in the study. Amendments to the protocol will be initiated by the Sponsor or 
CRO and must be approved by the IRB prior to implementation at the site. 

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13.10 Study Termination 
No formal statistical rule for early termination of this study for insufficient effectiveness of the 
study devices is defined. 
The Sponsor reserves the right to terminate or suspend the study for valid scientific or business 
reasons, or reasons related to the protection of subjects (e.g., the discovery of an unexpected, 
significant, or unacceptable risk to subjects).   
If the study is terminated prematurely or suspended, the Sponsor will promptly inform all 
Investigators of the termination or suspension and the reason(s). The IRB will also be informed, 
either by the Sponsor or Investigator, and provided with the reasons(s) for the termination or 
suspension. If applicable, regulatory authorities will be informed. 
The IRB may choose to discontinue the study at any Site for which they granted approval if the 
research study is not conducted in accordance with the IRB’s requirements or the research 
study indicates unexpected serious harm to subjects.    
13.11 Subject Confidentiality 
All information and data sent to the CRO concerning a subject or their participation in this study 
will be considered confidential. The Sponsor, CRO, Monitors, CEC, IRB, and regulatory 
representatives will have access to these confidential files and have the right to inspect and 
copy all records pertinent to this study for data verification. All data used in the analysis and 
reporting of this study will be without identifiable references to a subject. Subject names and 
contact information will be available to the Sponsor, CRO, and Monitors during review of 
medical records. Subject names may be available to the core laboratory and the CEC as they 
review study-related radiographic images and source documentation. This information will be 
treated with adherence to professional standards of confidentiality. In addition, upon regulatory 
request, subject records shall be provided to U.S. regulatory agencies. 
13.12 Statements of Compliance 
This study is to be conducted in accordance with ethical principles that have their origin in the 
Declaration of Helsinki, as defined in the following U.S. and international standards for good 
clinical practice: 
• 
International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice 
E6 (R2) (2016) 
• 
U.S. Code of Federal Regulations (CFR) regarding clinical studies (21 CFR including 
parts 11, 50, 54 and 56 and 812) and HIPAA (45 CFR 164.508) 
• 
ISO 14155: 2011 
13.13 Publications & Public Disclosure 
A publication committee will be formed to develop the publication plan and to oversee the 
development of the multi-center publication related to this study.  Refer to the Clinical Research 
Agreement for publications and public disclosure requirements and conditions.  

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13.14 Study Contacts 
Refer to the Sponsor Contact List for detailed contact information, including names, telephone 
numbers and email addresses for the Sponsor and CRO. 
14.0 DEFINITIONS 
Adverse device effect (ADE): An adverse event related to the use of an investigational 
medical device. [ISO 14155:2011(E)] 
• 
This definition includes AEs resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device. This definition also includes any event resulting from use 
error or from intentional misuse of the investigational medical device. 
Adverse event (AE): Any untoward medical occurrence in a clinical investigation subject that 
does not necessarily have a causal relationship with the study treatment. An AE can therefore 
be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or 
disease temporally associated with the use of an investigational product, whether or not related 
to the investigational product. An untoward event that is related to the study device may be 
referred to as an Adverse Device Event. [ref. ICH E6(R2) Good Clinical Practice: Consolidated 
Guidance]. 
Bleeding complications: Bleeding complications will be defined according to the GUSTO 
(Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, 
moderate, and mild bleeding events. 
Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes 
hemodynamic compromise and requires intervention. 
Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic 
compromise. 
Mild: Bleeding that does not meet criteria for either moderate or severe bleeding. 
Cardiac death: Any fatal event not attributable to a noncardiac cause. [Kandzari, 2018] 
Cardiac medication: Cardiac medications include: 
• 
Antiplatelet medications such as aspirin, Clopidogrel, Prasurgrel, Ticlid, Ticagrelor 
• 
Angiotensin converting enzyme (ACE) inhibitors 
• 
Angiotensin receptor blockers (ARBs) 
• 
Beta-blockers 
• 
Calcium channel blockers 
• 
Statins 
• 
Other lipid lower agents 
• 
Proton pump inhibitors 
• 
Diuretics 

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• 
Anticoagulants 
• 
Vasodilators 
Chronic total occlusion (CTO): Any non-acute total coronary occlusion fulfilling the 
angiographic characteristics consistent with high-grade native coronary stenosis (TIMI score of 
0 or 1) and estimated to be in duration of ≥ 3 months by clinical history and/or comparison with 
antecedent angiogram or electrocardiogram. [aligns with Asahi Intecc CTO-PCI, NCT02379923; 
ref. Kandzari 2018] 
Crossing time: Time from initial CTO guidewire entered into guide to successful crossing. 
[definition provided by Dr. David E. Kandzari] 
Device deficiency: Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. [ISO 14155:2011(E)] 
• 
Note: Device deficiencies include malfunctions, use errors, and inadequate labelling. 
Dissection Classification System [NHLBI 1989 classification system]:  
• 
Type A: Minor radiolucent areas within the coronary lumen during contrast injection with 
little or no persistence of contrast after the dye has cleared 
• 
Type B: Parallel tracts or double lumen separated by a radiolucent area during contrast 
injection, with minimal or no persistence after dye clearance 
• 
Type C: Appear as contrast outside the coronary lumen (“extraluminal cap”) with 
persistence of contrast after dye has cleared from the lumen 
• 
Type D: Spiral (“barber shop pole”) luminal filling defects, frequently with excessive 
contrast staining of the dissected false lumen 
• 
Type E: Appear as new, persistent filling defects within the coronary lumen 
• 
Type F: Dissections that lead to total occlusion of the coronary lumen without distal 
antegrade flow 
• 
Note: Type E and F dissections may represent thrombus 
J-CTO Score [Morino et al., 2011]: Difficulty grading and time assessment tool for predicting 
successful guidewire crossing through CTO of native coronary lesions, via the J-CTO score 
sheet.  

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Major adverse cardiac event (MACE): Any serious adverse experience that includes cardiac 
death, target lesion revascularization, or post-procedural MI (Q-wave or non-Q-wave, with CK-
MB > 3 ULN). Classification of an event as a MACE will be performed by the CEC. [aligns with 
Asahi Intecc CTO-PCI, NCT02379923, which was based on Academic Research Consortium 
definitions; ref. Kandzari 2018] 

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Myocardial infarction (MI): Q-wave or non-Q-wave, with CK-MB > 3 ULN [aligns with Asahi 
Intecc CTO-PCI, NCT02379923, which was based on Academic Research Consortium 
definitions; ref. Kandzari 2018] 
NYHA Heart Failure Classification [Dolgin et al, 1994]: 
I 
No limitation of physical activity. Ordinary physical activity does not cause undue 
fatigue, palpitation, dyspnea (shortness of breath). 
II 
Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity 
results in fatigue, palpitation, dyspnea (shortness of breath). 
III 
Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity 
causes fatigue, palpitation, or dyspnea. 
IV 
Unable to carry on any physical activity without discomfort. Symptoms of heart failure 
at rest. If any physical activity is undertaken, discomfort increases. 
Perforation Classifications [Ellis et al., 1994]: 
• 
Type I: Extraluminal crater without extravasation. 
• 
Type II: Pericardial or myocardial blush without contrast jet extravasation. 
• 
Type III: Extravasation through frank (≥ 1mm) perforation. 
Procedure success: Angiographic visualization of any guidewire in a position either distal or 
proximal to the occlusion depending on the route of access and the absence of in-hospital major 
adverse cardiac events (MACE). [aligns with Asahi Intecc CTO-PCI, NCT02379923; ref. 
Kandzari 2018] 
Procedure times [aligns with Asahi Intecc CTO-PCI, NCT02379923; ref. Kandzari 2018]:  
• 
Procedure start time: The first successful insertion of the guide catheter at an 
arteriotomy site is considered the start of the procedure.   
• 
Procedure end time: The procedure is considered complete once the guide catheter is 
removed from the arteriotomy site. 
• 
Total study device procedure time: The first successful insertion of a study device 
(catheter or guidewire) into the target artery is considered the start of the study device 
procedure. The study device procedure is considered complete once all study devices 
have been removed. 
Serious adverse event (SAE): Any untoward medical occurrence that results in death, is life-
threatening, requires inpatient hospitalization or prolongation of existing hospitalization, or 
results in persistent or significant disability/incapacity. [ref: ICH E6(R2) Good Clinical Practice: 
Consolidated Guidance]  
• 
Note: An AE is considered “life-threatening” if, in the view of either the Investigator or 
Sponsor, its occurrence places the subject at immediate risk of death. It does not 
include an AE that, had it occurred in a more severe form, might have caused death. 
Successful recanalization: Angiographic confirmation of crossing the chronic total occlusion 
and restoring blood flow to the affected area. [aligns with Asahi Intecc CTO-PCI, NCT02379923; 
ref. Kandzari 2018] 

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Target lesion: The CTO lesion being treated.  
Technical success: Successful guidewire recanalization. [Kandzari 2018]  
• 
Note: The technical success definition is applicable to investigational devices as at least 
one investigational guidewire must be used in every procedure.   
TIMI: Thrombolysis in myocardial infarction grading scale. [TIMI Study Group, 1985] 
TIMI 0 - no perfusion 
There is no antegrade flow beyond the point of 
occlusion. 
TIMI I - penetration without perfusion 
The contrast material passes beyond the area of 
obstruction but “hangs up” and fails to opacify the 
entire coronary bed distal to the obstruction for the 
duration of the cineangiographic filming sequence. 
TIMI II - partial perfusion 
The contrast material passes across the 
obstruction and opacifies the coronary bed distal to 
the obstruction. However, the rate of entry of 
contrast material into the vessel distal to the 
obstruction or its rate of clearance from the distal 
bed (or both) are perceptibly slower than its entry 
into or clearance from comparable areas not 
perfused by the previously occluded vessel – e.g., 
the opposite coronary artery or the coronary bed 
proximal to the obstruction. 
TIMI III - complete perfusion 
Antegrade flow into the bed distal to the obstruction 
occurs as promptly as antegrade flow into the bed 
proximal to the obstruction, and clearance of 
contrast material from the involved bed is as rapid 
as clearance from uninvolved bed in the same 
vessel or the opposite artery. 
TIMI Thrombus Grading Scale [Gibson, 2001] 
Grade 0 
No angiographic evidence of thrombus 
Grade 1 
Angiographic features suggestive of thrombus 
• 
Decreased contrast density 
• 
Haziness of contrast 
• 
Irregular lesion contour 
• 
A smooth convex meniscus at the site of a total occlusion 
• 
Suggestive, but not firmly diagnostic of a thrombus 
Grade 2 
Definite thrombus present in multiple angiographic projections 
• 
Marked irregular lesion contour with a significant filling defect – the 
thrombus’ greatest dimension is < ½ vessel diameter 
Grade 3 
Definite thrombus appears in multiple angiographic views 
• 
Greatest dimension from > ½ to < 2 vessel diameters 
Grade 4 
Definite large size thrombus present 
• 
Greatest dimension ≥ 2 vessel diameters 

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Grade 5 
Definite complete thrombotic occlusion of a vessel 
• 
A convex margin that stains with contrast persisting for several 
cardiac cycles 
Unanticipated Adverse Device Effect (UADE): Any serious adverse effect on health or safety 
or any life-threatening problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or application), or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, or 
welfare of subjects. [21 CFR 812.3(s)]

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15.0 REFERENCES 
Asahi Intecc. The Asahi Intecc PTCA Chronic Total Occlusion Study (CTO-PCI). In: 
ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2017-Jan-
27. Available from: https://clinicaltrials.gov/ct2/show/NCT02379923. 
Christofferson R, Lehmann K, Martin G, Every N, et al. Effect of Chronic Total Coronary 
Occlusion on Treatment Strategy. Am J Cardiol. May 2005;95(9):1088-1091. 
Dolgin M, Association NYH, Fox AC, Gorlin R, Levin RI, New York Heart Association. Criteria 
Committee. Nomenclature and criteria for diagnosis of diseases of the heart and great 
vessels. 9th ed. Boston, MA: Lippincott Williams and Wilkins; March 1, 1994. 
Ellis S, Ajluni S, Arnold A, Popma J, et al. Increased Coronary Perforation in the New Device 
Era: Incidence, Classification, Management, and Outcome. Circulation. 1994;90:2725-
2730. 
Farooq V, Serruys P, Garcia-Garcia H, Zhang Y, et al. The Negative Impact of Incomplete 
Angiographic Revascularization on Clinical Outcomes and its Association with Total 
Occlusions: The SYNTAX (Synergy Between Percutaneous Coronary Intervention with 
Taxus and Cardiac Surgery) Trial. J Am Coll Cardiol. 2013;61(3):282-294. 
Fefer P, Knudtson ML, Cheema AN, Galbraith PD, et al. Current perspectives on coronary 
chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J 
Am Coll Cardiol. Mar 2012;59(11):991-997. 
Gibson CM, de Lemos JA, Murphy SA, et al. Combination Therapy with Abciximab Reduces 
Angiographically Evident Thrombus in Acute Myocardial Infarction - a TIMI 14 Substudy. 
Circulation. 2001;103(21):2550-2554. 
Grantham JA, Marso SP, Spertus J, House J, et al. Chronic Total Occlusion Angioplasty in the 
United States. JACC Cardiovasc Interv. June 2009;2(6):479-486. 
Joyal D, Afilalo J, Rinfret S. Effectiveness of Recanalization of Chronic Total Occlusions: A 
Systematic Review and Meta-Analysis. Am Heart J. Jul 2010;160(1):179-187. 
Joyal D, Thompson C, Grantham A, Buller C, et al. The Retrograde Technique for 
Recanalization of Chronic Total Occlusions: A Step-by-Step Approach. JACC Cardiovasc 
Interv. Jan 2012;5(1):1-11. 
Kandzari D, Kini A, Karmpaliotis D, et al. Safety and Effectiveness of Everolimus-Eluting Stents 
in Chronic Total Coronary Occlusion Revascularization: Results from the EXPERT CTO 
Multicenter Trial. JACC Cardiovasc Interv. May 2015;8(6):761-769.  
Kandzari D, Grantham JA, Karmpaliotis D, Lombardi W, et al. Safety and Efficacy of Dedicated 
Guidewire and Microcatheter Technology for Chronic Total Coronary Occlusion 
Revascularization: Principal Results of the Asahi Intecc Chronic Total Occlusion Study. 
Coronary Artery Disease. Dec 2018;29(8):618-623. 

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Morino Y, Abe M, Morimoto T, et al. Predicting Successful Guidewire Crossing Through Chronic 
Total Occlusion of Native Coronary Lesions Within 30 Minutes: The J-CTO (Multicenter 
CTO Registry in Japan) Score as a Difficulty Grading and Time Assessment Tool. JACC: 
Cardiovascular Interventions. Feb 2011;11(2):213-221.  
Olivari Z, Rubartelli P, Piscione F, et al. Immediate Results and One-Year Clinical Outcome 
After Percutaneous Coronary Interventions in Chronic Total Occlusions: Data from a 
Multicenter, Prospective, Observational Study (TOAST-GISE). J Am Coll Cardiol. 
2003;31:1672-1678.  
Patel V, Brayton K, Tamayo A, Mogabgab O, et al. Angiographic Success and Procedural 
Complications in Patients Undergoing Percutaneous Coronary Chronic Total Occlusion 
Interventions: A Weighted Meta-Analysis of 18,061 Patients From 65 Studies. JACC 
Cardiovascular Interventions. Feb 2013;6(2):128-136. 
Prasad A, Rihal C, Lennon R, et al. Trends in Outcomes After Percutaneous Coronary 
Intervention for Chronic Total Occlusions: A 25-Year Experience from the Mayo Clinic. J 
Am Coll Cardiol. Apr 2007;49(15):1611-1618.   
Stone G, Kandzari D, Mehran R, Colombo A, et al. Percutaneous Recanalization of Chronically 
Occluded Coronary Arteries: A Consensus Document: Part I. Circulation. 2005;112:2364-
2372. 
TIMI Study Group. The Thrombolysis in Myocardial Infarction (TIMI) Trial – Phase I Findings. N 
Engl J Med. 1985;312:932-936. 
Valenti R, Migliorini A, Signorini U, et al. Impact of Complete Revascularization with 
Percutaneous Coronary Intervention on Survival in Patients with at Least One Chronic 
Total Occlusion. European Heart Journal. 2008;29:2336-2342. 

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16.0 REVISION HISTORY 
REV 
Description of Change 
Date 
A 
Initial release to FDA 
11 Apr 2019 
B 
Release of IDE-approved copy. In section 7.3.3, updated 
mathematical expression of null hypothesis from H0: µ < PG to H0: µ ≤ 
PG upon recommendation from FDA. Added J-Score definition to 
section 14.0 and reference to section 15.0. 
22 May 2019 
C 
Added 30-Day (± 7 days) assessment to collect 30-day MACE as part 
of secondary objectives for the study.  Updated Figure 4 and Table 4 
to reflect 30-Day assessment. Updated NCT number. Added 
abbreviations of CHF and NYHA to Abbreviations table. Updated 
exclusion criterion 7 in synopsis to reflect corresponding change in 
body of protocol. Updated exclusion criterion 2 to be consistent with 
protocol definition of an MI. Definition of Severe CHF added to 
exclusion criterion 8. References to “Angiographic Core Laboratory 
Guidelines” changed to “instructions provided by the core laboratory” 
Clarified reference to transient sinus bradycardia to heart rate ≤50 
bpm. Added definition of New York Heart Association (NYHA) Heart 
Failure classification. Minor grammatical corrections to entire 
document. 
04 Feb 2020 
 
 
 

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APPENDIX A: GUIDELINER CATHETER INVESTIGATIONAL 
INSTRUCTIONS FOR USE 
 
 

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APPENDIX B: TRAPLINER CATHETER INVESTIGATIONAL 
INSTRUCTIONS FOR USE 
 
 

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APPENDIX C: TURNPIKE CATHETER INVESTIGATIONAL 
INSTRUCTIONS FOR USE 
 
 

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APPENDIX D: SPECTRE GUIDEWIRE INVESTIGATIONAL 
INSTRUCTIONS FOR USE 
 
 

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APPENDIX E: RAIDER GUIDEWIRE INVESTIGATIONAL 
INSTRUCTIONS FOR USE 
 
 

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APPENDIX F: WARRIOR GUIDEWIRE INVESTIGATIONAL 
INSTRUCTIONS FOR USE 
 
 

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APPENDIX G: BANDIT GUIDEWIRE INVESTIGATIONAL 
INSTRUCTIONS FOR USE 
 
 

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APPENDIX H: R350 GUIDEWIRE INVESTIGATIONAL INSTRUCTIONS 
FOR USE