Scoreflex NC - Scoring PTCA Catheter: A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Safety and Device Procedural Success of the Scoreflex NC Scoring PTCA Catheter in Subjects With Stenotic Coronary Arteries During Percutaneous Coronary Intervention.
Phase: NA
Conditions: Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases
Sponsor: OrbusNeich

  
Scoreflex NC – IDE Clinical Study Protocol  
Protocol Number: VP-0730 
 
Phase:  US Investigational Device Exemption (IDE #G180168) 
Date:  30 November 2018 
Version: 1.0 
Clinical Trials Identifier:  NCT03763747 
 
 
Principal Investigator: 
David E. Kandzari, MD, FACC, FSCAI 
Piedmont Heart Institute 
95 Collier Road, Suite 2065 
Atlanta, Georgia 30309 USA 
Phone: +1 404 605 2800 
E-mail: david.kandzari@piedmont.org 
 
Sponsor: 
OrbusNeich Medical Trading, Inc. 
5363 N.W. 35th Avenue  
Fort Lauderdale, FL 33309 USA 
Phone: +1 954 730-0711 
Facsimile: +1 954 730-7601 
E-mail: dmorrell@orbusneich.com 
 
 
 
 
 
 
Notwithstanding the contents of this protocol, the clinical trial will be conducted in accordance with local 
regulations of the US.  This document contains information that is privileged or confidential and may not 
be disclosed unless such disclosure is required by applicable laws and regulations.  The information in this 
document is the property of OrbusNeich Medical Trading, Inc. and may not be reproduced, published, or 
disclosed to others without written authorization from OrbusNeich Medical Trading, Inc. 

 
 
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Protocol Signature Page 
 
Scoreflex NC - Clinical Study Protocol  
Protocol Number: VP-0730 
 
 
Sponsor: OrbusNeich Medical Trading, Inc. 
 
Date:  30 November 2018 
Version: 1.0 
 
We, the undersigned, have read and approve this protocol and agree to its content. 
 
 
__________________________________________ 
Sponsor Representative 
 
__________________________________________ 
Date 
 
 
 
__________________________________________ 
Clinical Study Principal Investigator 
 
__________________________________________ 
Date 
 
 
 
__________________________________________ 
Core Laboratory Director 
 
__________________________________________ 
Date 
 
 
 
 
 

 
 
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PROTOCOL VERSION TRACKING 
 
Version 
Date 
01  
30 November 2018  
 
 
 
 
PROTOCOL REVISION HISTORY 
Version 
Date 
Revision 
01 
30 November 2018 
Initial Release 
 
 
 

 
 
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Protocol Summary 
 
Study Design and Rationale 
 
A prospective, open label, multi-center, single arm, observational study designed to evaluate the 
acute safety and device procedural success of the Scoreflex NC Scoring PTCA catheters in 
subjects with stenotic coronary arteries during percutaneous coronary intervention. 
 
Two-hundred (200) subjects will be treated at up to 15 U.S. sites with the Scoreflex NC Scoring 
PTCA catheter during their index procedure. All subjects will be screened according to the 
protocol inclusion and exclusion criteria and will be followed through hospital discharge.    
 
Study Summary 
Name of Company 
OrbusNeich Medical Trading, Inc. 
Product 
Scoreflex NC Scoring PTCA catheter 
Protocol Number  
VP-0730 
Protocol Title 
Scoreflex NC – Scoring PTCA Catheter  
A prospective, open label, multi-center, single arm, observational 
study designed to evaluate the safety and device procedural success 
of the Scoreflex NC scoring PTCA catheter in subjects with stenotic 
coronary arteries during percutaneous coronary intervention. 
Planned Number of  
Subjects and Sites 
Two-hundred (200) subjects will be enrolled at up to 15 U.S. sites. 
Primary Endpoints 
Device procedural success consisting of the following: 
•  Successful delivery, inflation, deflation, and withdrawal of the 
study balloon 
•  No evidence of vessel perforation, flow limiting dissection 
(grade C or higher) or reduction in TIMI flow from baseline as 
related to the Scoreflex NC study balloon  
•  Final TIMI flow grade of 3 at the conclusion of the PCI 
procedure 
 
Secondary Endpoints 
Angiographic Procedural efficacy: 
•   Final diameter stenosis ≤ 50% in at least one of the Scoreflex NC 
attempted lesions following completion of the interventional 
procedure, including adjunctive stenting 
 
The following clinical endpoints will be measured through hospital 
discharge: 
•In-hospital Major Adverse Cardiac Events (MACE), a 
composite of: 
-- All death (cardiac and non-cardiac) 
-- Myocardial infarction (MI) 
-- Target Lesion Revascularization (TLR), clinically indicated 
•In-hospital stent thrombosis (ST) within the target vessel 
•Clinically significant arrhythmias (requiring intervention) 

 
 
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Peri-procedural endpoints:  
•  Occurrence of Scoreflex NC Study Balloon rupture 
• Improvement in Minimum Lumen Diameter (MLD) following 
use of Scoreflex NC catheter (measured by QCA) 
Randomization 
Not Applicable 
Follow-Up Schedule 
Subjects will be followed through hospital discharge 
Required Medication 
Therapy 
Anti-platelet medications should be prescribed according to the 
standard of care at each investigational site. 
Clinical Inclusion 
Criteria 
1. Subject is ≥ 18 years of age. 
2. Subject or a legally authorized representative must provide 
written informed consent prior to any study related procedures. 
3. Subject must agree not to participate in any other clinical study 
during hospitalization for the index procedure that would 
interfere with the endpoints of this study. 
4. Subjects must have a single or double vessel coronary artery 
disease and clinical evidence of ischemic heart disease, such as 
CAD, stable / unstable angina or silent ischemia.  
 
Angiographic 
Inclusion Criteria 
5. Subject must have de novo or restenotic lesion(s) in native 
coronary arteries, including in-stent restenosis suitable for 
percutaneous coronary intervention.  
6. A maximum of two lesions, including at least one target lesion, in 
up to two coronary arteries. 
7. Target lesion must have a reference vessel diameter (RVD) 
between 1.75 and 4.0 mm by visual estimation. 
8. Target lesion(s) must have a diameter stenosis of ≥70% by visual 
estimation and may include chronic total occlusions (CTO). 
9. The non-target lesion must be located in different coronary 
artery from the Target lesion. 
10. Treatment of non-target lesion, if any, must be completed 
prior to treatment of target lesion and must be deemed a clinical 
angiographic success as visually assessed by the physician.   
Clinical Exclusion 
Criteria 
1.  Subject with a known hypersensitivity or contraindication to 
aspirin, heparin, bivalirudin, anti-platelet medications, or 
sensitivity to contrast media which cannot be adequately pre-
medicated. 
2. Subject with known diagnosis of STEMI or NSTEMI at index 
presentation or within 7 days of study screening.   
3.  Subject with known pregnancy or is nursing. Women of 
child-bearing potential should have a documented negative 
pregnancy test within 7 days before index procedure. 
4. Planned or actual target lesion treatment with an unapproved 
device, atherectomy, laser, cutting balloon or thrombectomy 
during the index procedure. 
5. A serum creatinine level > 2.0 mg/dl within 7 days prior to index 
procedure. 
6. Cerebrovascular accident (CVA) within the past 6 months. 

 
 
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7. Active peptic ulcer or active gastrointestinal (GI) bleeding within 
the past 6 months. 
8. Subject has a known left ventricular ejection fraction (LVEF) 
<30% (LVEF may be obtained at the time of the index procedure 
if the value is unknown, if necessary) 
9. Target lesion located within an arterial or saphenous vein graft or 
graft anastomosis 
 
Angiographic 
Exclusion Criteria 
 
10. More than two lesions requiring treatment. 
11. Target lesion longer than 30 mm by visual estimation. 
12. Extreme angulation (90º or greater) proximal to or within the 
target lesion. 
13. Previous percutaneous intervention of lesions in a target vessel 
(including side branches) conducted within 9 months before the 
study procedure and located within 10 mm from the current 
target lesion. 
14. Target lesion demonstrating severe dissection prior to planned 
deployment of the Scoreflex NC device 
15. Unprotected left main coronary artery disease. (Greater than 
50% diameter stenosis) 
16. Coronary artery spasm of the target vessel in the absence of a 
significant stenosis. 
17. Target lesion with angiographic presence of probable or definite 
thrombus. 
18. Target lesion involves a bifurcation requiring treatment with 
more than one stent or pre-dilatation of a side branch >2.0 
mm in diameter. 
19. Non-target lesion to be treated during the index procedure meets 
any of the following criteria: 
• 
Located within a bypass graft (venous or arterial) 
• 
Left main location 
• 
Chronic total occlusion  
• 
Involves a bifurcation (e.g., bifurcations requiring 
treatment with more than 1 stent) 
• 
Treatment not deemed a clinical angiographic success  
 
A maximum of two lesions, including at least one target lesion, may be treated during the 
index procedure. 
 
Non-target lesion should be treated first and deemed a clinical angiographic success by 
visual assessment prior to treatment of the target lesion. 
 
The lesion identified as the target lesion is intended to be treated during the index 
procedure with a Scoreflex NC study device.  
 
 
 

 
 
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Non-Target Lesion 
• A maximum of one non-target lesion (in addition to one target lesion in a target 
vessel) may be treated in a non-target vessel with a commercial treatment during 
the index procedure and must occur prior to treatment of target lesion. 
• Treatment of non-target lesion must be deemed a clinical angiographic success for 
subjects to be eligible for enrollment into the study. 
• Target and non-target lesions must be located in different coronary arteries. 
 
Target Lesion 
• Lesion that is to be treated with the Scoreflex NC study device during the index 
procedure. 
• Target lesions (maximum of 2) may be located in the same or different coronary 
arteries. 
• Target lesion composed of multiple focal lesions that can be covered with one 
stent will be considered as a single lesion. 
 
Note: A separate Scoreflex NC study device must be used for treatment of each target 
lesion. 
 
  Statistical Methods 
Enrollment 
definition 
A subject is considered enrolled in the study following provision of informed
consent and upon insertion of the investigational device into a guide 
catheter. 
Follow-up 
Schedule 
Subjects will be followed through hospital discharge. 
Primary  
Statistical Plan 
s A single-arm observational trial to evaluate the safety and clinical 
effectiveness through a composite end-point of device procedural success 
and assessment of angiographic efficacy as shown through a clinically 
significant reduction in percent diameter stenosis as determined by an 
independent Core Lab using QCA.  The primary endpoint will be assessed 
using descriptive statistics on the Intention To Treat patient population.  No 
hypothesis testing will be performed.  The primary endpoint will be reported 
using frequencies, percentages, and two-sided exact 95% confidence 
interval. 
 Secondary endpoints are evaluated in the unselected patient population set 
using descriptive statistics. The secondary endpoints are summarized using 
the mean, median, standard deviation, minimum, maximum, and two-sided 
95% confidence intervals. Frequencies, percentages and two- sided exact 
95% confidence intervals will be reported for binary endpoints as 
appropriate, for clinical endpoints.  
Sample Size 
A sample size of two-hundred (200) subjects has been chosen in order to 
characterize the performance of the device. All enrolled subjects will be 
analyzed on an intent-to-treat (ITT) basis as well as per protocol criteria. 

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Investigator Statement 
 
 
I have read the Protocol and Appendices and agree that it contains all necessary details for 
me and my staff to conduct this study as described.  I will provide copies of this Protocol and 
all pertinent information to the study to the study personnel under my supervision.  I will 
discuss this material with them and ensure they are fully informed regarding the study 
devices and the conduct of the study.  I will make all reasonable efforts to adhere to the study 
Protocol. 
 
I will conduct the study in accordance with the Protocol, Good Clinical Practice [GCP] 
guidelines, as well as local regulations, and I accept respective revisions of the Protocol 
approved by authorized personnel of the Sponsor and by regulatory authorities.  I am aware 
that, before beginning this study, the institutional review board responsible for such matters 
in the clinical facility where it will be conducted must approve this Protocol. 
 
I agree to provide all subjects with Informed Consent forms, as required by government 
regulations and GCP guidelines.  I further agree to report to the Sponsor any Adverse Events 
in accordance with the terms of the Protocol and U.S. Food and drug Administration 
regulation 21 Code of Federal Regulations 812.150(a)(1). 
 
 
 
_____________________________________________ 
Site Participating Investigator Name (print) 
 
 
_____________________________________________ 
Signature 
 
 
_____________________________________________ 
Date 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
1. General Information ................................................................................................12 
1.1. Principal Investigator ..........................................................................................12 
1.2. Site Management, Data Coordination and Monitoring .......................................12 
1.3. Clinical Events Committee .................................................................................12 
1.4. Angiographic Core Laboratory ...........................................................................12 
1.5. Sponsor ...............................................................................................................12 
2. Background Information ........................................................................................13 
2.1. Description of Investigational Device ................................................................13 
2.2. Summary of Findings from Non-Clinical Studies ..............................................14 
2.3. Summary of Known and Potential Risks and Benefits .......................................15 
2.4. Statement of Trial Conduct .................................................................................15 
2.5. Study Population .................................................................................................15 
2.6. Summary of Relevant Literature ........................................................................16 
3. Trial Objectives and Purpose .................................................................................19 
4. Trial Design ..............................................................................................................19 
4.1. Selection and Withdrawal of Subjects ................................................................19 
4.2. Inclusion Criteria ................................................................................................19 
4.3. Exclusion Criteria ...............................................................................................20 
4.4. Subject Withdrawal Criteria ...............................................................................21 
5. Treatment of Subjects..............................................................................................22 
5.1. Non-Target Lesion ..............................................................................................22 
5.2. Target Lesion ......................................................................................................22 
5.3. Study Procedures ................................................................................................23 
6. Assessments of Safety and Efficacy ........................................................................26 
6.1. Primary end-point ...............................................................................................26 
6.2. Secondary end-points ..........................................................................................26 
6.3. Angiographic Core Laboratory ...........................................................................27 
6.4. Clinical Events Adjudications ............................................................................27 
7. Adverse Events .........................................................................................................27 
7.1. Serious Adverse Events ......................................................................................28 
7.2. Anticipated Adverse Device Effects ...................................................................28 
7.3. Unanticipated Adverse Device Effects ...............................................................28 
8. Device Failure and Device Malfunction .................................................................28 
9. Statistics ....................................................................................................................29 
10. Direct Access to Source Data/Documents ..............................................................29 
11. Quality Control and Quality Assurance ................................................................30 
11.1 Selection of Clinical Sites and Investigator .......................................................30 
11.2 Protocol and Informed Consent Approval .........................................................30 
11.3 Protocol Deviations ............................................................................................31 
11.4 Training ..............................................................................................................31 
11.5 Good Clinical Practice Compliance ...................................................................31 
11.6 Monitoring .........................................................................................................32 
11.7 Quality Assurance Assessments ........................................................................32 
11.8 Regulatory Agency Inspection ...........................................................................32 

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11.9 Executive Committee .........................................................................................33 
12 Ethics ........................................................................................................................33 
13 Data Handling and Record Keeping .....................................................................33 
13.1 Source Documentation  ......................................................................................33 
13.2 Case Report Form (eCRF) Completion .............................................................33 
13.3 Record Retention ...............................................................................................34 
13.4 Investigational Device Management..................................................................34 
13.5 Close-Out Visit ..................................................................................................35 
14 Insurance .................................................................................................................35 
15 Publication Policy....................................................................................................35 
16 Bibliography ............................................................................................................36 
 
 

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Abbreviations 
AE 
adverse event 
CEC 
Clinical Events Committee 
CRF 
case report form 
FDA 
Food and Drug Administration 
ICF 
informed consent form 
ICH 
International Committee of Harmonization 
IDE 
Investigational Device Exemption 
IRB 
Institutional Review Board 
MI 
myocardial infarction 
PCI 
percutaneous coronary intervention 
PTCA 
Percutaneous Transluminal Coronary Angioplasty 
QCA 
quantitative coronary angiography 
SAE 
serious adverse event 
TIMI 
Thrombolysis In Myocardial Infarction 
TLF 
target lesion failure 
TLR 
target lesion revascularization 
TVF 
target vessel failure 
TVR 
target vessel revascularization 
UADE 
unanticipated adverse device event 
 
 
 

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1. General Information 
1.1. Principal Investigator 
David E. Kandzari, MD, FACC, FSCAI 
95 Collier Road, Suite 2065 
Atlanta, Georgia 30309 USA 
Phone: 404-605-5526 
E-mail: david.kandzari@piedmont.org 
 
1.2. Site Management, Data Coordination and Monitoring  
Clinlogix, LLC 
Spring House Corporate Center  
8 Spring House Innovation Park, Suite 100 
Ambler, PA 19002 USA 
Debra Jovanovich, Senior Clinical Project Manger 
Phone: 215.855.9054 x 7062  
E-mail: debra.jovanovich@clinlogix.com 
 
1.3. Clinical Events Committee 
Clinlogix, LLC 
Spring House Corporate Center  
8 Spring House Innovation Park, Suite 100 
Ambler, PA 19002 USA 
Daniel Rider, Senior Clinical Data Analyst 
Phone: 215.855.9054 x 7040  
E-mail: daniel.rider@clinlogix.com  
 
1.4. Angiographic Core Laboratory 
Beth Israel Deaconess Medical Center Imaging Laboratory [BIDMC-IL] 
940 Commonwealth Avenue 
Boston, MA 02215 USA 
Jeffery J Popma, MD, Director Interventional Cardiology Clinical Services 
Phone: +1 617-632-9210 
E-mail: JPopma@bidmc.harvard.edu 
 
1.5. Sponsor 
OrbusNeich Medical Trading, Inc. 
5363 NW 35th Avenue 
Fort Lauderdale, Florida 33309 USA 
Phone: +1 954-730-0711 
Facsimile: +1 954-730-7601 
 
 Debbie Morrell, Clinical Research Manager 
Phone: +1 954-343-6467 
E-mail: dmorrell@orbusneich.com 
 

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2. Background Information 
The Scoreflex NC Scoring PTCA Catheter is a coronary dilatation catheter designed with a 
short rapid-exchange tip distal to the dilation balloon and an external integral wire on the 
outside of the balloon, such that the guide wire and the integral wire act as scoring elements 
external to the balloon when the balloon is inflated.  The presence of the external scoring 
elements outside the angioplasty balloon create a focal stress pattern which allows for 
opening of lesions at lower pressures using a concept of Focused Force Angioplasty [FFA].   
 
In the early 1990’s, the FFA concept evolved out of the clinical practice of the “buddy wire” 
technique for enhanced angioplasty effectiveness by placing guide wires alongside 
angioplasty balloons as they were inflated.  This practice was developed as the use of fixed-
wire angioplasty balloon catheters was common, therefore a practice was developed of 
placing guide wires across lesions prior to dilation to “protect” the distal vasculature by 
preserving guide wire access in the case of acute vessel closure due to vasospasm or 
dissections post-angioplasty1.Using this technique it was observed that having a guide wire 
across a stenosis when an angioplasty balloon was inflated was useful in dilating calcified2 
and resistant lesions3 in what has become known as the “buddy wire” technique.  Based upon 
this practice, Solar and Ischinger4 introduced the concept of FFA with a balloon angioplasty 
system designed specifically with the guide wire and an external wire on the outside of the 
balloon to introduce high focal stresses along the luminal surface of the balloon.  There are 
several cutting and scoring design concepts based upon FFA that have been introduced to 
the US market, including devices using a parallel external wire similar to the commercially 
available FX miniRAIL. 
 
2.1. Description of Investigational Device 
The Scoreflex NC Scoring PTCA Catheter is a catheter designed for easy guidewire 
exchange and available with balloon diameters in 1.75, 2.0, 2.25, 2.5, 2.75 3.0, 3.5 
and 4.0 mm, in balloon lengths of 10, 15 and 20 mm and a catheter working length 
of 140cm.  The balloon material is made of minimally compliant Grilamid L25 
material and can be inflated by injecting dilute contrast media solution through the 
trailing hub of the catheter.  The nominal inflation pressure is 12 ATM with a rated 
burst pressure of 20 ATM. The proximal shaft of the catheter is composed of a 
female luer connector bonded to a PTFE coated stainless steel hypotube and the 
scoring wire is laser welded to the distal end of the stainless steel hypotube. The 
proximal shaft joins with a smooth transition to the distal shaft (composed of an 
outer nylon tube with the balloon/tip tube and scoring wire welded at the distal tip). 
The cutting section of the scoring wire is outside of the balloon. Two radiopaque 
platinum/iridium marker bands are located on the scoring wire and aligned with the 
balloon shoulders to ensure accurate positioning of the balloon. The tip lumen is 
compatible with a standard 0.014 inch (0.36mm) guidewire. The guidewire enters 
the catheter tip and advances coaxially out the Rx port, thereby allowing both coaxial 
guidance and rapid exchange of catheter with a single standard length guidewire. 
Two marked sections, 5mm in length, are located on the proximal shaft indicating 
the catheter position relative to the tip of either a brachial or femoral guiding catheter. 

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The catheter is lubricated with hydrophilic coating on the tip and the distal outer 
body surface; the tip lumen and the balloon are lubricated with silicone coating The 
design of this dilatation catheter does not incorporate a lumen for distal dye 
injections or distal pressure measurements.  
 
                                          Table 1.0:  Scoreflex NC Device Size Matrix: 
 
 
Balloon Diameter (mm) 
Balloon Length (mm) 
10 
15 
20 
1.75 
X 
  
X 
2.00 
X 
X 
X 
2.25 
  
X 
  
2.50 
X 
X 
X 
2.75 
  
X 
  
3.00 
X 
X 
X 
3.50 
  
X 
  
4.00 
X 
 
X 
 
2.2. Summary of Findings from Non-Clinical Studies 
In Vitro bench testing and characterization of the Scoreflex NC Scoring PTCA 
Catheter has been undertaken according to the requirements of the Guidance of 
Industry and FDA Staff – Class II Special Controls Guidance document for 
Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, 
September 8, 2010.  Likewise, biocompatibility testing was undertaken according 
to the recommendations found in the aforementioned PTCA guidance and ISO 
10993-1:2009, Biological evaluation of medical devices – Part 1: evaluation and 
testing. 
 
 
 
 
 
 

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2.3. Summary of Known and Potential Risks and Benefits 
 
2.3.1. Potential Risks 
There is extensive clinical and commercial experience worldwide with 
cardiac catheterization and interventional procedures utilizing non-
compliant and scoring PTCA catheters. It is expected that the surgical and 
procedural risks will not be significantly different with the use of this device 
or in this clinical trial.    
The Scoreflex NC Scoring PTCA Catheter has been marketed outside of the 
US since 2016.  An on-going, prospective post-market surveillance program 
continues to show these devices to be safe and effective. 
2.3.2. Risk Management 
The investigational plan is specifically designed to manage and minimize 
risks through careful subject selection, thorough training of investigators and 
adherence to the pre-determined time points to assess subject clinical status 
and regular clinical monitoring visits by Sponsor appointed monitoring 
personnel.  
2.3.3. Potential Benefit 
 
The Scoreflex NC Scoring PTCA Catheter is indicated for balloon dilatation 
of a stenotic portion of a coronary artery stenosis in patients evidencing 
coronary ischemia for the purpose of improving myocardial perfusion, 
including in-stent restenosis. PTCA dilation of complex, highly stenosed or 
heavily calcified lesions with non-compliant scoring balloons to optimize 
lesion preparation prior to stent placement may facilitate procedural success.  
Optimal stent deployment is known to reduce the potential of restenosis, stent 
thrombosis and target lesion revascularization. The safety and performance 
demonstrated for non-compliant PTCA scoring catheters demonstrate that the 
risk-to-benefit ratio is within reason for the foreseeable risks.   
 
2.4. Statement of Trial Conduct 
This study is intended to be conducted according to Good Clinical Practice (GCP) 
guidelines5, local regulatory requirements, and subject ethical treatment must be in 
accordance with the World Medical Association Declaration of Helsinki: Ethical 
Considerations for Medical Research Involving Human Subjects6. 
2.5. Study Population 
The target study population is subjects with evidence of ischemia and clinically 
indicated for one- or two-vessel revascularization procedures by percutaneous 
coronary intervention. 
 

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2.6. Summary of Relevant Literature 
 
2.6.1 FX miniRAIL™ Catheter Clinical Experience 
The FX miniRAIL catheter, a dedicated FFA balloon angioplasty catheter, was 
introduced in 2003 and shown in clinical practice to lower stenosis resolution 
dilation pressures, fewer spiral dissections, less recoil, a larger minimum lumen 
diameter, and a trend toward a lower restenosis rate than that seen with Plain Old 
Balloon Angioplasty [POBA]7.  
The FFA mechanism of action of the FX miniRAIL catheter was demonstrated in a 
porcine angioplasty model where with histology post-angioplasty a controlled 
dissection along a focal “nick” was observed with the FX catheter compared to a 
relatively uncontrolled mural disruption was observed with conventional 
angioplasty balloon catheters; an observation supported with clinical case examples 
showing a localized scoring with the FX catheter as shown by IVUS and OCT8. 
The first-in-man clinical experience with the FX miniRAIL catheter to support CE-
marking was a single-center registry in Germany where 30 subjects presenting with 
37 lesions, de novo (68%) and in-stent restenosis (32%), treated with the FX catheter 
followed by stenting (51%), beta-radiation (11%), and no further treatment (38%) 
which resulted in a 8-month major adverse coronary event [MACE] rate of 8.1%, 
where all events were target lesion revascularization [TLR]9.  
The pivotal IDE trial of the FX miniRAIL catheter was a multicenter registry at 12 
sites where 263 subjects presenting with single or multiple vessel coronary artery 
disease [CAD] treated with the FX catheter, which resulted in an in-hospital,  
Procedural Success rate of 94.8%, defined as <50% diameter stenosis in at least one 
FX-attempted lesions without death, Q wave or non-Q wave MI, or emergency 
CABG during the hospital stay, and a Clinical Success rate of 97.1%, defined as 
freedom from MACE – death, Q wave or non-Q wave MI, or TLR at the 14-day 
follow-up9. The clinical success included seven (7) subjects with at least one MACE 
event. Six (6) of the patients experienced MACE event(s) while in-hospital, one (1) 
experienced a MACE event, a non-Q wave MI related to a subsequent non-target 
lesion revascularization, not due to the FX miniRAIL procedure.    
 
 
 
 
 
 
 

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The pivotal trial is summarized in the following table: 
Table 2.0:  Summary of FX miniRAIL Pivotal trial 
Study Device 
Primary endpoint 
Subjects 
Reference 
FX miniRAIL 
RX PTCA  
 
Procedural Success: (in-hospital) 94.8% (235/248) 
 
< 50% final diameter stenosis in at least one of the 
attempted lesions with death, Q-wave or non-Q-
wave MI, or emergency CABG during the hospital 
stay 
 
Clinical Success: 97.1%  (231/238) 
Freedom from MACE – death, Q wave or non-Q 
wave MI, or TLR at the 14-day follow-up.   
• Seven (7) subjects with at least one MACE event.  
• Six (6) of the patients experienced MACE 
event(s) while in-hospital,  
• One (1) experienced a MACE event, a non-Q 
wave MI related to a subsequent non-target 
lesion revascularization, not due to the FX 
miniRAIL procedure 
 
263 
enrolled  
P0200379 
 
 
 
2.6.2 Scoreflex™ Clinical Experience 
The first FFA catheter developed by OrbusNeich was the SafeCut™ catheter.  Two 
case reports for this first generation product were published in 2007 demonstrating 
the effectiveness of the SafeCut catheter to treat a case with a resistant calcified 
lesion10  a case of in-stent restenosis 1.5 years post-PCI11. 
The second generation of FFA catheters developed by OrbusNeich was the 
Scoreflex catheter.   Pre-clinical bench top and finite element analysis [FEA] 
modeling work with the Scoreflex has demonstrated the mechanistic action of the 
FFA design with demonstration of superior expansion in a calcium tube model at 
lower pressures than with POBA. FEA modeling revealed concentration of the stress 
observed in the outside of the calcified plaque just opposite the scoring element is 
the underlying mechanism, and validation of the scoring mechanism of crack 
propagation indeed being associated with the scoring elements using ultra-high 
speed videography12. 
The clinical experience with the Scoreflex catheter found in the literature includes 
several single center studies investigating the safety and effectiveness of FFA 
treatment to prepare lesions for optimal stent deployment and an interesting case 
report.   

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Kato et al.13 reported on a series of 21 consecutive patients presenting with heavily 
calcified lesions treated with rotational atherectomy [RA] followed by either 
Scoreflex or conventional balloon angioplasty/no angioplasty prior to DES 
implantation. Quantitative IVUS imaging was then performed and followed up with 
QCA.  The use of the Scoreflex balloon was associated with a significantly higher 
number of cracks in the calcific plaque as visualized by IVUS compared to balloon 
angioplasty/no angioplasty, 1.8±0.4 versus 1.0±0.8; p=0.02.  Also, the DES 
deployment after Scoreflex dilation showed a significantly improved rate of 
symmetrical deployment, defined as quotient of the minimum and maximum stent 
diameters measured at the point of minimal cross-sectional area [CSA] over balloon 
angioplasty/no angioplasty, 0.83±0.05 versus 0.76±0.07.  No acute stent thrombosis 
and no major complications (cardiac death, myocardial infarction, emergent bypass 
surgery) were observed at in-hospital follow-up.  12-month angiographic follow up 
found no restenosis with Scoreflex compared to the balloon angioplasty/no 
angioplasty cohort, which experienced a restenosis rate of 29%. 
Sadamatusu et al14 reported on their single center randomized comparison in 46 
consecutive patients of the effectiveness of Scoreflex predilation versus the use of a 
non-compliant balloon prior to IVUS-guided DES implantation on stent deployment 
and clinical outcomes.  The use of the NC balloons resulted in significantly larger 
balloon sizing (3.33±0.28 vs. 3.09±0.33mm, p=0.01) and significantly higher 
dilation pressures (11.6±3.2 vs. 8.6±2.7 atm., p<0.01) compared with the use of 
Scoreflex.  However, QCA at 8-month follow-up revealed a significantly smaller in-
stent late lumen loss (0.71±0.63 vs. 0.23±0.52mm, p=0.03) with the Scoreflex group, 
while there were no significant differences observed in the MACE rates between the 
groups. 
Okuya et al15 presented a case report in which a long dissection developed in a 
patient after balloon angioplasty resulting in a flow-compromising intramural 
hematoma. This persisted after a DES was placed over the original balloon dilation 
site.  It was decided to attempt to use the Scoreflex balloon to create a fenestration 
between the true lumen and the hematoma to relieve the flow obstruction.  The 
Scoreflex balloon was able be inserted and deployed distal to the DES which resulted 
to restoration of TIMI-3 flow and the patient’s symptoms subsided with a good 
angiographic result.   Follow-up coronary angiograms at 3-months and 1 year 
showed that the false lumen remained closed with good coronary flow in the treated 
vessel. 
 Jujo et al16 reported on their single-center randomized study in 66 consecutive 
patients comparing the effectiveness of predilation prior to DES implantation with 
the Scoreflex balloon versus conventional balloon on final stent expansion.  OCT 
imaging was used to shown that stent expansion was shown to be significantly 
higher after pre-dilation with Scoreflex as compared to conventional balloon 
angioplasty with a semi-compliant balloon (68.0% vs. 62.1%, p=0.017) and intimal 
disruption was more prevalent in the scoring group (68.0% vs. 38.4%, p=0.035) and 
more extensive (102° vs. 65°, p=0.038).  Only one case of restenosis necessitating 
TLR was observed in the conventional angioplasty group, otherwise no adverse 

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clinical events, including death, myocardial infarction, or stent thrombosis were 
observed in either group. 
The clinical literature on the Scoreflex balloon has shown this FFA technology to 
be safe and effective in improving stent deployment after predilation in de novo and 
in heavily calcified lesions as compared to conventional balloon angioplasty 
predilation. 
 
3. Trial Objectives and Purpose 
To assess the acute safety and device procedural success of the Scoreflex NC scoring 
PTCA catheter in its intended use for the dilatation of coronary artery stenosis (≥70% 
diameter stenosis).  
 
4. Trial Design 
 
A prospective, open label, multi-center, single arm, observational study designed to 
evaluate the acute safety and device procedural success of the Scoreflex NC scoring 
PTCA catheter in subjects with stenotic coronary arteries during percutaneous coronary 
intervention. 
 
Two-hundred (200) subjects will be treated at up to 15 U.S. sites with the Scoreflex NC 
catheter during their index procedure. All subjects will be screened according to the 
protocol inclusion and exclusion criteria and will be followed through hospital discharge. 
 
4.1 Selection and Withdrawal of Subjects 
Once the subjects have signed the Institutional Review Board (IRB) approved study 
informed consent form (ICF) and research authorization forms (RA/HIPAA) and 
have met all general inclusion and exclusion criteria, the subjects will be considered 
eligible to be enrolled in the study to receive treatment with the Scoreflex NC 
dilatation catheter. A subject is considered enrolled in the study upon insertion of the 
investigational device into a guide catheter. Upon enrollment, a subject identification 
number will be assigned to each subject in a consecutive manner within each clinical 
site.  
 
4.2 Inclusion Criteria 
 
4.2.1 Clinical Inclusion Criteria 
• Subject is ≥ 18 years of age. 
• Subject or a legally authorized representative must provide written informed 
consent prior to any study related procedures. 

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• Subject must agree not to participate in any other clinical study during 
hospitalization for the index procedure that would interfere with the 
endpoints of this study. 
• Subjects must have a single or double vessel coronary artery disease and 
clinical evidence of ischemic heart disease, such as symptomatic CAD, 
stable / unstable angina or silent ischemia. 
 
4.2.2 Angiographic Inclusion Criteria 
• Subject must have de novo or restenotic lesion(s) in native coronary arteries, 
including in-stent restenosis that are suitable for percutaneous coronary 
intervention.  
• A maximum of two lesions, including at least one target lesion, in up to two 
coronary arteries. 
• Target lesion must have a reference vessel diameter (RVD) between 1.75 
and 4.0 mm by visual estimation. 
• Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation 
and may include chronic total occlusions (CTO) 
• The non-target lesion must be located in different coronary artery from the 
Target lesion. 
• Treatment of non-target lesion, if any, must be completed prior to treatment 
of target lesion and must be deemed a clinical angiographic success as 
visually assessed by the physician. 
 
4.3 Exclusion Criteria 
 
4.3.1 Clinical Exclusion Criteria 
• Subject with a known hypersensitivity or contraindication to aspirin, heparin, 
bivalirudin, anti-platelet medications, or sensitivity to contrast media, which 
cannot be adequately pre-medicated. 
• Subject with known diagnosis of STEMI or NSTEMI at index presentation 
or within 7 days of study screening.   
• Subject with known pregnancy or is nursing. Women of child-bearing 
potential should have a documented negative pregnancy test within 7 days 
before index procedure. 
• Planned or actual target lesion treatment with an unapproved device, 
atherectomy, laser, cutting balloon or thrombectomy during the index 
procedure. 
• A serum creatinine level > 2.0 mg/dl within seven days prior to index 
procedure. 
• Cerebrovascular accident (CVA) within the past 6 months. 
• Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 
months. 
• Subject has a known left ventricular ejection fraction (LVEF) <30% (LVEF 
may be obtained at the time of the index procedure if the value is unknown, 
if necessary) 

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• Target lesion located within an arterial or saphenous vein graft or graft 
anastomosis 
 
4.3.2 Angiographic Exclusion Criteria 
• More than two lesions requiring treatment. 
• Target lesion longer than 30 mm by visual estimation. 
• Extreme angulation (90º or greater) proximal to or within the target lesion. 
• Previous percutaneous intervention of lesions in a target vessel (including 
side branches) conducted within 9 months before the study procedure and 
located within 10 mm from the current target lesion. 
• Target lesion demonstrating severe dissection prior to planned use of the 
Scoreflex NC device 
• Unprotected left main coronary artery disease. (Greater than 50% diameter 
stenosis) 
• Coronary artery spasm of the target vessel in the absence of a significant 
stenosis. 
• Target lesion with angiographic presence of probable or definite thrombus.  
• Target lesion involves a bifurcation requiring treatment with more than one 
stent or pre-dilatation of a side branch >2.0 mm in diameter. 
• Non-target lesion to be treated during the index procedure meets any of the 
following criteria: 
o Located within a bypass graft (venous or arterial) 
o Left main location 
o Chronic total occlusion 
o Involves a bifurcation (e.g., bifurcations requiring treatment with 
more than 1 stent) 
o Treatment not deemed a clinical angiographic success. 
 
 
 
4.4 Subject Withdrawal Criteria 
Each enrolled subject shall remain in the study until completion of the required follow-
up period, however, a subject’s participation in any clinical study is voluntary and the 
patient has the right to withdraw at any time without penalty or loss of benefit. 
Conceivable reasons for discontinuation may include, but not be limited to, the following: 
• Subject death 
• Subject voluntary withdrawal  
• Subject withdrawal by physician as clinically indicated 
• Subject lost-to follow-up 
The reason for subject discontinuation must be documented on the CRF and source 
documents. The Primary Investigators must also report all subject discontinuations to 
their IRB, MEC, or HREC as defined by their Institution’s procedure. 

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5 Treatment of Subjects 
 
A maximum of two lesions, including at least one target lesion, may be treated during the 
index procedure. 
 
Non-target lesion should be treated first and deemed a clinical angiographic success by 
visual assessment prior to treatment of the target lesion. 
The lesion identified as the Target lesion is intended to be treated during the index 
procedure with a Scoreflex NC study device. 
 
5.1 Non-Target Lesion 
 
• A maximum of one non-target lesion (in addition to one target lesion in a target 
vessel) may be treated in a non-target vessel with a commercial treatment during 
the index procedure and must be completed prior to treatment of target lesion. 
• Treatment of non-target lesion must be deemed a clinical angiographic success 
as visually assessed by the physician for subjects to be eligible for enrollment 
into the study. 
• Target and non-target lesions must be located in different coronary arteries. 
 
 
5.2 Target Lesion 
 
• Lesion that is to be treated with the Scoreflex NC study device during the index 
procedure. 
• Target lesions (maximum of 2) may be located in the same or different coronary 
arteries. 
• Target lesion composed of multiple focal lesions that can be covered with one 
stent will be considered as a single lesion. 
o Note: A separate Scoreflex NC study catheter must be used for treatment of 
each target lesion, if there is more than one target lesion identified to be 
treated.  
 
 
 

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Table 1.0 
Schedule of Procedures 
 
≤ 7 Days 
before 
procedure 
  ≤ 24 hours 
before 
procedure 
Procedure 
Post-
procedure 
/ Hospital 
Discharge 
Study Eligibility  
X 
 
 
 
Informed consent 
X 
 
 
 
Demographics, Medical history including 
coronary medical history 
X 
 
 
 
Physical assessment, including vital signs  
X 
 
 
X 
Angina class 
X 
X 
 
X 
12-lead ECG 
 
X 
 
X 
Cardiac Medication review 
 
X 
X 
X 
Pregnancy test (women only) 
X 
 
 
 
Laboratory Tests 
  
  
  
  
    Serum Creatinine 
X 
 
 
 
    CBC with platelets 
X 
 
 
 
    CK Total/ CK-MB 
 
Xa 
Xb 
X 
Angiographic Assessment  
 
 
X 
 
Review of Adverse events and device-
related events 
 
  
X 
X 
a. 
All subjects must have CK/CK-MB drawn within 24 hours before the procedure to determine eligibility; 
however, if the results are not available, eligibility may be based upon troponin values.  
b.     For three CK-MB draws. The first draw should be performed immediately after the procedure, the second draw 
should be performed 6-12 hours post–procedure and the third draw should be performed 18-24 hours post-
procedure, or prior to discharge, whichever comes first.  
 
 
5.3 Study procedures 
  
5.3.1 Written Informed Consent 
Written informed consent must be obtained prior to initiation of any study-
related procedures that are performed solely for the purpose of determining 
eligibility to participate in the study. Once the subjects have signed the 
Institutional Review Board (IRB) approved study informed consent form 
(ICF) and research authorization forms (RA/HIPAA) and have met all general 
inclusion and exclusion criteria, the subjects will be considered eligible to be 
enrolled in the study to receive treatment with the Scoreflex NC 
investigational device. A subject is considered enrolled in the study upon 

Protocol Number: VP-0730                                                                                               30 November 2018       
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insertion of the investigational device into a guide catheter. Upon enrollment, 
a subject identification number will be assigned to each subject in a 
consecutive manner within each clinical site. The site enrollment log should 
be completed with the subject enrollment information.  
 
5.3.2 Up to 7 days Prior to Index Procedure 
The following pre-procedure data (specific data is noted in the eCRF) must 
be collected within 7 days prior to the index procedure for all subjects: 
• Review of Inclusion and Exclusion criteria 
• Demographics, Medical history including coronary medical history  
• Angina class 
• Laboratory tests: 
o Serum Creatinine 
o CBC with platelets  
o Pregnancy test for females of child-bearing potential with analysis per 
local practice (serum and/or urine) 
 
5.3.3 Within 24 hours Prior to Index Procedure 
The following pre-procedure data must be collected within 24 hours prior to 
the index procedure for all subjects: 
• Current antiplatelet, anti-thrombotic and cardiac medications 
• 12-lead electrocardiogram (ECG) 
• Laboratory tests: 
o Cardiac enzymes: CK Total and, if CK Total is abnormal (>1x ULN), 
CK-MB must be performed. 
o If CK/CK-MB results are not available; eligibility may be based upon 
troponin values.  
Note: CK/CK-MB must be drawn prior to the index procedure; 
however if the results are not available, eligibility may be based upon 
troponin values.  
 
                                 Cardiac enzyme collection requirements: 
o For subjects who present with Stable Angina or Silent Ischemia: 
- CK/CK-MB must be drawn prior to the index procedure.  
- The results of the enzyme testing are not required to be available 
prior to the index procedure.     
  
 
5.3.4 Index Procedure 
The start of the index procedure is defined as the time of sheath insertion. If 
a previously placed sheath is used (i.e., from an earlier diagnostic 
procedure), index procedure start time is defined as the time of guide 
catheter insertion into sheath for wiring the target lesion. During cardiac 
catheterization, the following procedures and assessments must be 
completed.   
 

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•   Perform angiography according to the Angiographic Core Laboratory 
procedure guidelines. 
•   Confirm angiographic eligibility criteria. 
•   Treat the non-target lesion, if any, prior to treatment of the target lesion as 
described in Section 6.1. 
•   If treatment of non-target lesion was successful, continue with enrolling 
the subject in the study. 
•   If the subject is enrolled, treat subject accordingly with the Scoreflex NC 
catheter and perform angiography according to the Angiographic Core 
Laboratory procedure guidelines and collect study related data.  
• If more than one lesion is treated with the Scoreflex NC catheter, similarly 
perform angiography according to the Angiographic Core Laboratory 
procedure guidelines and collect study related data. 
 
5.3.5 Completion of Index Procedure 
The completion of the Index Procedure is defined as the time the guide 
catheter is removed, post final angiography. The following information 
should be collected: 
• Document procedural information, including non-target lesion (if 
applicable), target lesion of lesions with use of the Scoreflex NC study 
balloon, stent (if applicable) and post-dilatation (if applicable) on the 
appropriate CRFs. 
• Record cardiac medications 
• Record antithrombotic and antiplatelet medications. 
• If an AE should occur, Complete AE assessment and source document 
collection 
• Record any device deficiencies that might have occurred before or during 
the procedure as described in Section 8. 
 
5.3.6 Hospital Discharge/ End of Study 
    The following information must be collected post index procedure: 
• Clinical Status assessment including Angina assessment/Ischemia 
classification. 
• 12-lead ECG within 24 hours after the index procedure or prior to hospital 
discharge, whichever occurs first. 
• CK-MB: CK-MB draws must be obtained within 24 hours post-procedure. 
The first draw should be performed immediately after the procedure, the 
second draw should be performed 6-12 hours post–procedure and the third 
draw should be performed 18-24 hours post-procedure. 
• Note: If the subject is discharged prior to 18 hours-post procedure, the 
third CKMB draw must be obtained at the time of discharge (it is 
recommended that in these cases the third CK-MB draw occurs no earlier 
than 16 hours post-procedure). 
• Record cardiac medications including antiplatelet and anti-thrombotic 
therapy 

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• Record the occurrence of any In-hospital Major Adverse Cardiac Events 
(MACE), including: 
o All death (cardiac and non-cardiac) 
o Myocardial infarction (MI) 
o Target Lesion Revascularization (TLR), clinically indicated 
o In-hospital stent thrombosis (ST) within the target vessel 
o Or Clinically significant arrhythmias (requiring intervention) 
• If an AE should occur, Complete AE assessment and source document 
collection 
 
 
6 Assessment of Safety and Efficacy 
Clinical events and procedural device success will be assessed on a per-patient level. 
6.1  Primary safety and efficacy endpoint 
The study primary Device Procedural Success endpoint shall be defined as 
consisting of the following: 
• Successful delivery, inflation, deflation and withdrawal of the study balloon 
• No evidence of vessel perforation, flow limiting dissection (grade C or higher) 
or reduction in TIMI flow from baseline related to the Scoreflex NC study 
balloon 
• Final TIMI flow grade of 3 at the conclusion of the PCI procedure 
 
6.2  Secondary endpoints 
The following secondary Angiographic Procedural efficacy endpoint will be 
measured: 
• Final diameter stenosis ≤ 50% in at least one of the Scoreflex NC attempted 
lesions following completion of the interventional procedure, including 
adjunctive stenting  
 
The following secondary clinical endpoints will be measured through hospital 
discharge: 
• 
In-hospital Major Adverse Cardiac Events (MACE), a composite of: 
o All death (cardiac and non-cardiac) 
o Myocardial infarction (MI) 
o Target Lesion Revascularization (TLR), clinically indicated 
• 
In-hospital stent thrombosis (ST) within the target vessel 
• 
Clinically significant arrhythmias (requiring intervention) 
The following secondary peri-procedural endpoints will be measured through 
hospital discharge:  
• Occurrence of Scoreflex NC study balloon rupture 

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• Improvement in Minimum Lumen Diameter (MLD) following use of 
Scoreflex NC coronary dilatation catheters (measured by QCA)  
 
Both MI and ST are to be determined by the Academic Research Consortium (ARC) 
classification criteria. 17  MI to be classified into various types and include the 99th 
percentile upper reference limit (URL) decision limits for biomarkers employed. 18    
 
Myocardial Infarction will be defined as: 
 
• Q-Wave MI: Development of new (i.e., not present on the subject’s ECG before 
allocation) pathological Q-waves in 2 or more leads lasting 0.04 seconds with post-
procedure CK-MB levels elevated above normal. 
• Non–Q-Wave MI: Elevation of post-procedure CK-MB levels to >3.0 times ULN 
without new Q-waves. 
 
For subjects undergoing bypass surgery, a peri-operative MI will be defined as 
follows: 
a) Total CK-MB >5× ULN. 
     or 
b) Presence of new pathologic Q-waves as defined above. 
6.3 Angiographic Core Laboratory 
Angiographic results will be submitted to an independent Core Laboratory for 
review and quantification of angiographic parameters (Beth Israel Deaconess 
Medical Center Imaging Laboratory, Boston, MA). 
6.4  Clinical Events Adjudication 
All clinical end-points are to be adjudicated by an independent clinical events 
committee using definitions consistent with the investigational plan.  The CEC will 
develop a prospective CEC charter before any study data is adjudicated. 
 
7 Adverse Events 
An AE is defined as any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users, or 
other persons, whether or not related to the investigational medical device.  
Any pre-existing condition known to the investigator will not, in general, be reportable 
as an AE, unless the investigator believes that the participation of the subject in this study 
contributed to the progression of that condition. 
When an AE has, by its nature, a prolonged course, the event will be considered a single 
event and not multiple events.  

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Death itself should not be recorded as an AE, but should only be reflected as an outcome 
of another specific AE. Any AE experienced by the study subjects after enrollment and 
up until index procedure hospital discharge must be recorded in the CRF. 
  
7.1 Serious Adverse Events 
             Any AE that:  
• Led to death 
• Led to a serious deterioration in the health of the subject that resulted in 
o Life-threatening illness or injury or 
o Permanent impairment of a body structure or a body function or 
o In-patient hospitalization or prolongation of existing hospitalization.  
o Medical or surgical intervention to prevent permanent impairment of a body 
structure or a body function 
o Led to fetal distress, fetal death, or a congenital abnormality or birth defect  
o The following hospitalizations are not considered AEs/SAEs: 
▪ Planned hospitalizations for a pre-existing condition.    
 
7.2 Anticipated Adverse Device Effects 
A serious adverse device effect (ADE) that by its nature, incidence, severity or outcome 
has been previously identified as noted in the protocol risks section, 2.3 or the device 
IFU. 
 
7.3  Unanticipated Adverse Device Effects 
Per United States Code of Federal Regulations (CFR) Title 21, Part 812.3, an 
unanticipated ADE (UADE) is any serious adverse effect on health or safety or any life-
threatening problem or death caused by or associated with a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree of incidence 
in the 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.       
 
8 Device Failure and Device Malfunction 
A device has failed or malfunctioned if it is used in accordance with the IFU/IB but does 
not perform according to the IFU/IB and negatively impacts the treatment.   
Device deficiencies and other device issues as related to the use of the Scoreflex NC 
study device should be captured on the device malfunction CRF and reported to the 
Sponsor. If an AE results from a device deficiency or other device issue as related to the 
Scoreflex NC study device, the AE should also be reported on the appropriate CRF.  
 

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9  Statistics 
This is a single-arm observational trial looking at safety and clinical effectiveness 
through a composite end-point of device procedural success and assessment of 
angiographic efficacy as shown through a clinically significant reduction in percent 
diameter stenosis as determined by an independent Core Lab using QCA. The study 
sample size of 200 patients is based upon treatment of a reasonable number of subjects 
with the study device to provide a reliable and meaningful assessment of device 
performance, rather than based upon any statistical hypothesis of an endpoint.  
Primary end-point 
The primary endpoint will be assessed in the intent-to-treat (ITT) patient population. 
Every effort will be made to reduce bias by obtaining as much follow-up as possible. 
No imputation of missing data is done for the primary analysis. 
Secondary end-points 
All secondary endpoints are evaluated in the ITT patient population. 
Statistical Methods 
All primary and secondary endpoints will be evaluated using descriptive statistics only. 
No hypothesis tests will be performed.  
Statistics for continuous outcomes will include mean, median, standard deviation, 
minimum, maximum, including two-sided 95% confidence intervals, under the 
assumption that the data are in a normal distribution. Binary outcomes will be 
summarized using frequencies, percentages and two-sided exact 95% confidence 
intervals. 
The baseline demographic and lesion characteristics and angiographic outcomes will be 
evaluated by descriptive statistics for the ITT population, with the same methods as used 
for outcome data.  
 
 
10 Direct Access to Source Data/Documents 
The Investigator and the associated institution will permit direct access to source 
data/documents for study-related monitoring, audits, IRB review and regulatory 
inspections. 
Subjects providing informed consent agree to allow Sponsor or designee access and 
copying rights to pertinent information in their medical records concerning their 
participation in this study. The Investigator will obtain, as part of the informed consent, 
permission for study monitors or regulatory authorities to review in confidence any 
records identifying the subjects in this study. This information may be shared with 

Protocol Number: VP-0730                                                                                               30 November 2018       
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regulatory agencies; however, the Sponsor undertakes not to otherwise release the 
patient's personal and private information.  
 
11   Quality Control and Quality Assurance 
 
11.1 
Selection of Clinical Sites and Investigator 
The sponsor will select Investigators who are qualified by training and experience, and 
are legally entitled to perform clinical research and to participate in the investigation of 
the study device. Sites will be selected based upon review of a recent site assessment and 
the qualifications of the Primary Investigator at the site. 
11.2 
Protocol and Informed Consent Approval  
 
11.2.1 Protocol/Subject Informed Consent Initial Approval 
Institutional Review Board (IRB) approval for the protocol, informed consent form 
and other study related documents will be obtained by the Primary Investigator at 
each investigational site prior to participation in this trial. The approval letter must 
be signed by the IRB chairperson or authorized representative prior to the start of this 
trial and a copy must be provided to the Sponsor. In addition, the Investigator or 
designee will provide the Sponsor with all required documentation necessary for 
initial and ongoing study approval at their site.  
In accordance with the investigational site IRB requirements, the Investigator will 
(a) advise the IRB of the progress of this trial on a regular basis until study 
completion; (b) obtain written IRB approval at predetermined time points to continue 
the trial; and (c) submit any amendments to the protocol as well as associated 
informed consent form changes and obtain written IRB approval obtained prior to 
implementation.  
No investigative procedures other than those defined in this protocol will be 
undertaken on the enrolled subjects without the written agreement of the IRB and 
Sponsor. 
 
11.2.2 Protocol/Subject Informed Consent Approval of Amendments 
If the protocol and/or the subject informed consent need an amendment, the Sponsor 
is required to submit such amendment to the Regulatory Agencies and/or other 
regulating body in each participating country for approval. Approved protocol 
amendments will be provided to the Investigators by the Sponsor prior to 
implementing the amendment. The Primary Investigator is responsible for notifying 
the IRB of the protocol amendment (administrative changes) or obtaining IRB 
approval of the protocol amendment (changes in subject care or safety), according to 
the instructions provided by the Sponsor with the protocol amendment.   

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Acknowledgement/approval by the IRB of the protocol amendment must be 
documented in writing prior to implementation of the protocol amendment. Copies 
of this documentation must also be provided to the Sponsor. 
 
11.3 
Protocol Deviations 
It is the Investigator's responsibility to ensure that there are no deviations from the 
protocol in full compliance with all established procedures of the IRB/MEC/HREC. The 
Investigator will not deviate from the protocol for any reason except in cases of medical 
emergencies, when the deviation is necessary to protect the life or physical wellbeing of 
the subject. All deviations must be reported to the Sponsor.  The occurrence of protocol 
deviations will be monitored by the Sponsor or designee. Investigators will inform their 
IRB of all protocol deviations in accordance with their specific IRB reporting policies 
and procedures.  
In the event that an Investigator does not comply with the Investigator Agreement or 
protocol, the Sponsor will notify the Investigator of the site’s non-compliance. Continued 
non-compliance may result in further escalation in accordance with the Sponsor’s SOP.  
 
11.4 
Training 
11.4.1 Site Training 
All Investigators and study personnel are required to attend Sponsor training sessions, 
which may be conducted at an Investigator's meeting, a site initiation visit or other 
appropriate training sessions. Over-the-phone training will take place as required. 
Training of Investigators and study personnel will include, but is not limited to, the 
investigational plan, investigational device usage, protocol requirements, case report 
form completion and study personnel responsibilities. All Investigators and study 
personnel who are trained must sign a training log (or an equivalent) upon completion 
of the training. Investigator and study personnel must not perform any study-related 
procedures prior to being trained. All Investigators must be trained to the protocol 
and study procedures prior to enrolling subjects. 
 
11.4.2 Training of Sponsor’s Monitors 
The Sponsor’s monitors or designee will be trained to the investigational plan, 
protocol, randomization instructions, case report forms and investigational device 
usage. The Sponsor or designee is responsible for the training. Training may be 
conducted in accordance with the OrbusNeich or their designee’s SOP. 
 
11.5 
Good Clinical Practice Compliance 
The trial will be conducted in compliance with the protocol, Good Clinical Practice 
guidelines5, ISO 14155 (Clinical investigation of medical devices for human subjects), 

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21 CRF 812 (Code of Federal Regulations Title 21-Investigational Device Exemptions), 
as well as local regulations, and applicable regulatory requirements. 
 
11.6 
Monitoring 
Monitoring of the clinical study will be conducted in a detailed and orderly manner in 
accordance with established principles of GCP and applicable regulations. A Sponsor 
study monitor or their delegate will visit the study sites regularly and will maintain 
frequent telephone and written communication. 
 
Periodic monitoring visits will be made at all active investigational sites throughout the 
clinical study to assure that the investigator obligations are being fulfilled and all 
applicable regulations and guidelines are being followed. These visits will assure that the 
facilities are still acceptable, the protocol and investigational plan are being followed, the 
IRB has approved protocol changes as required, confirm that appropriate subjects have 
been enrolled with adequate documented consent, complete records are being maintained, 
confirm that there is complete follow up of the safety and efficacy endpoint data 
appropriate and timely reports have been made to Sponsor or their delegate and the IRB, 
the study device and study device inventory are controlled, and the investigator is 
carrying out all agreed-upon activities. 
During monitoring visits, the monitor will perform a review of inclusion/exclusion 
criteria, informed consent, HIPAA (Health Insurance Portability and Accountability Act) 
authorization, events meeting criteria for expedited event reporting, as well as safety and 
efficacy endpoints. Additional review will be performed on a site-by-site basis, as 
warranted by the findings of previous monitoring visits. Any discrepancies will be noted 
and resolved. During monitoring visits, the site will ensure system access is available to 
the CRAs so that they may verify the data entries against the source documentation. 
 
11.7 
Quality Assurance Assessments 
The Sponsor and/or designee may conduct periodic compliance assessments (on-site 
audits) at various study sites. A Sponsor representative or designee may request access 
to all trial records, including source documentation, for inspection and duplication during 
a compliance assessment. The Investigator and research coordinator must be available to 
respond to reasonable requests and queries made during the compliance assessment 
process.  
 
11.8 
Regulatory Agency Inspection 
In the event that an Investigator is contacted by a Regulatory Agency in relation to this 
study, the Investigator will notify the Sponsor immediately. The Investigator and 
research coordinator must be available to respond to reasonable requests and inspection 
queries made during the inspection process. The Investigator must provide the Sponsor 
with copies of all correspondence that may affect the review of the current study. The 
Sponsor will provide any needed assistance in response to regulatory inspections. 

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11.9 
Executive Committee 
The Executive Committee is comprised of the Principal Investigator, Core Laboratory 
Director, and the Sponsor Vice-President of Clinical and Regulatory Affairs, or their 
designees. This committee will oversee general aspects of the study. This oversight 
includes review of the final protocol, ongoing monitoring of the general data collection, 
and review and consideration of implementation or operational issues that may arise and 
warrant a protocol amendment or other corrective action. The Executive Committee will 
also approve policy regarding presentations and/or publications. 
12    Ethics 
All subjects must provide written informed consent in accordance with the Site’s IRB, 
using an IRB-approved informed consent form.  The final eligibility for the trial will be 
the final pre-intervention angiographic qualification. 
Study-specific procedures must not be performed until a signed informed consent has 
been obtained.  The Investigator/designee, who has been trained on the protocol, will 
explain the nature and scope of the study, potential risks and benefits of participation, 
and answer questions from the patient. 
All subjects are to be fully informed and study conduct must be in accordance with the 
World Medical Association Declaration of Helsinki: Ethical Considerations for Medical 
Research Involving Human Subjects6. 
13   Data Handling and Record Keeping 
This study will use an electronic CRF (eCRF) to collect study specific data. Qualified 
study staff at each site will perform primary data collection from source document 
reviews. Before initiation of the trial, the investigator's site staff members who will be 
entering data will receive training on the completion of the eCRF. The Sponsor or their 
delegate will perform clinical monitoring, including review of eCRFs with verification 
to the source documentation. 
 
During monitoring visits, the site will ensure that access is available to the patient EMR 
for the clinical research associate (CRA), so that the CRA may verify the data entries in 
the eCRF against source documentation.   
 
13.1 
Source Documentation 
Source documents are defined as original documents, data and records. Regulations 
require that the Investigator maintain source documents in the subject’s medical 
records, which confirm the data entered on the case report forms. 
13.2 
Case Report Form (CRF) Completion 
Primary data collection based on source-documented hospital and/or clinic chart 
reviews will be performed clearly and accurately by site personnel trained on the 

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protocol and CRF completion. The Sponsor or designee will provide clinical 
monitoring as specified in Section 11.6 Monitoring. 
 
13.3 
Record Retention 
The Investigator/Site will maintain all records pertaining to this study for three years 
following study completion, or as otherwise instructed by the Sponsor, or per local 
requirements whichever is longer. ICH guidelines require that essential documents 
be retained until at least 2 years after the last approval of a marketing application in 
an ICH region and until there are no pending or contemplated marketing applications 
in an ICH region or at least 2 years have elapsed since the formal discontinuation of 
clinical development of the investigational product. 
To comply with these requirements, the investigator will not dispose of any records 
relevant to this study without either (1) written permission from the Sponsor, or (2) 
providing an opportunity for the Sponsor to archive the records. The investigator shall 
take responsibility for maintaining adequate and accurate source documents of all 
observations and data generated as required during this study, including any data 
queries received from the Sponsor or its designees. Such documentation is subject to 
inspection by the Sponsor or its agents, the IRB, or other regulatory agencies. 
The Investigator will be notified by the Sponsor of the date of marketing approval or 
discontinuation of the study. The Investigator will obtain permission from the 
Sponsor in writing before destroying or transferring control of any study records. 
 
13.4 
Investigational Device Management 
13.4.1 Investigational Device Accountability 
The Sponsor will ship the investigational device (Scoreflex NC) to the Primary 
Investigator (or designee) only at each site. The Primary Investigator will maintain 
adequate records of the receipt and disposition of the investigational device on the 
device inventory log and case report form (eCRF), including catalog number, device 
lot number, date implanted, subject identification number. When the enrollment 
phase of the study is complete, any unused investigational devices will be returned to 
the Sponsor and along with a completed Device Accountability Log. The Device 
Accountability Log must document the disposition of all investigational devices 
including those that have been returned to the Sponsor. Use of any investigational 
device outside of the protocol (e.g. compassionate use) is strictly forbidden and may 
constitute grounds for removal of the Investigator/Site from the study. 
13.4.2 Investigational Device Return 
All unused investigational devices must be returned to the Sponsor when enrollment 
is complete. Investigators will be notified in writing of enrollment completion. All 
investigational devices or any remaining components that are associated with a 
device malfunction must be returned to the Sponsor. 
 

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13.5 
Close-Out Visit 
The close out visit will be conducted as a final review of the study and the data gathered 
by the site, and provide confirmation of the study record retention requirements.  The 
Sponsor study monitor or their delegate will verify that the site's records are in order, in 
anticipation of a regulatory authority/Sponsor audit.  Scheduling of the Close-Out Visit 
(COV) will be based on site enrollment, anticipated completion dates or status of the trial. 
 
Any outstanding regulatory or monitoring issues will be reviewed.  Any missing 
documents will be retrieved at the visit or sent in prior to the close out visit.  All queries 
should be resolved prior to the visit or during the visit. In addition, the site will also be 
reminded to submit a final report to the IRB at the close-out of the study.  It will be the 
responsibility of the monitor/CRA to follow-up with the site until the final report is 
received, or otherwise agreed upon by OrbusNeich.  
 
14    Insurance 
The study is covered under the Sponsor’s liability insurance policy.  A certificate of 
insurance containing essential information about the insurance coverage can be provided to 
the study Sites upon request. 
15   Publication Policy 
The Sponsor of this study, recognizing the seminal importance of this investigation, is 
committed to the unrestricted and widespread dissemination of all primary and secondary 
endpoint results and tertiary analyses. At the conclusion of the study, a multicenter abstract 
reporting the primary results may be prepared by the Principal Investigators (in collaboration 
with the Executive Committee, directors of the core laboratories, clinical events committee, 
and Primary Investigators from high enrolling sites) and presented at an annual scientific 
meeting (e.g., Transcatheter Cardiovascular Therapeutics, EuroPCR, the American Heart 
Association, or the American College of Cardiology).  A multicenter publication may 
similarly be prepared for publication in a reputable scientific journal. The publication of the 
principal results from any single center experience within the trial is not allowed until both 
the preparation and publication of the multicenter results.  
Following analysis and presentation of the primary endpoint results, active participation of 
all committee members, Investigators from high enrolling sites, and core laboratory 
personnel will be solicited for data analysis and abstract and manuscript preparation. 
Submission of all abstracts and publications regarding the primary endpoint and secondary 
endpoints from the study requires approval by the Principal Investigators after review by the 
Executive Committee.  
 
 
 
 

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16   Bibliography 
 
1. Selig MB. Lesion Protection During Fixed-Wire Balloon Angioplasty: Use of the 
“Buddy Wire” Technique and Access Catheters. Catheterization and Cardiovascular 
Diagnosis 25:331-335 (1992) 
 
2. Yazdanfar S, Ledley GS, Alfieri A, Strauss C, Kotlet MN. Parallel Angioplasty 
Dilatation Catheter and Guide Wire: A New Technique for the Dilatation of Calcified 
Coronary Arteries. Catheterization and Cardiovascular Diagnosis 28:72-75 (1993) 
 
3. Stillabower ME. Longitudinal Force Focused Coronary Angioplasty: A Technique 
for Resistant Lesions.  Catheterization and Cardiovascular Diagnosis 32: 196-198 
(1994) 
 
4. Solar R and Ischinger TA. Focused Force Angioplasty Theory and Application. 
Cardiovascular Radiation Medicine 4:47-50 (2003) 
 
5. ICH Harmonized Guideline E6(R2) Good Clinical Practice; dated 19 November 2016 
 
6. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving 
Human Subjects, Adopted by the 18th WMA General Assembly, Helsinki, Finland, 
June 1964 and last amended by the 64th WMA General Assembly, Fortaleza, Brazil, 
October 2013 
 
7. Ischinger TA, Solar R, Hitzke E. Improved outcome with novel device for low-
pressure PTCA in de novo and in-stent lesions. Cardiovascular Radiation Medicine 
4:2-6 (2003) 
 
8. Meerkin D, Lee SH, Tio FO, Grube E, Wong SC, Hong MK.  Effects of Focused 
Force Angioplasty: Pre-Clinical Experience and Clinical Confirmation.  J Invasive 
Cardiology 17:4 April (2005) 
 
9. FX miniRAIL RX Percutaneous Transluminal Coronary Angioplasty (PTCA) 
Catheter - X-Technologies. Summary of Safety and Effectiveness and Instructions 
for Use. PMA No. P020037.  June 11, 2003 
 
10. Mori S, Otsuka Y, Kawamura A.  Usefulness of the SafeCut Dual Wire PTCA 
Catheter for the Treatment of Calcified Lesions.  J Invasive Cardiology 19:8; E254-
E256, August (2007) 
 
11. Otsuka Y, Kasahara Y, Kawamura A. Use of SafeCut Balloon™ for Treatment of In-
Stent Restenosis of a Previously Underexpanded Sirolimus–Eluting Stent with 
Heavily Calcified Plaque. J Invasive Cardiology 19:12; E359-E362, December 
(2007) 
 

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12. Kawase Y, Saito N, Watanabe S, Bao B, Yamamoto K, Wantanabe H, Higame H, 
Matsuo H, Ueno K, Kimura T.  Utility of a scoring balloon for a severely calcified 
lesion: bench test and finite element analysis.  Cardiovasc Interv and Ther 29:134-
139 (2014) 
 
13. Kato R, Ashikaga T, Sakurai K, Ito J, Ogawa T, Tahara T, Yokoyama Y, Satoh Y.  
Influence of additional ballooning with a dual-wire balloon after rotational 
atherectomy to expand drug-eluting stent for calcified lesions. Cardiovasc Interv and 
Ther 27:155-160 (2012) 
 
14. Sadamatsu K, Yoshida K, Yoshidomi Y, Koga Y, Amari K, Tokuuou T.  Comparison 
of pre-dilation with a compliant versus a dual wire scoring balloon for coronary 
stenting.  World J Cardiovasc Diseases 3:395-400 (2013) 
 
15. Okuya Y, Fukushima K, Hori Y, Murayama T, Komiyama N.  Fenestration using a 
scoring balloon Scoreflex® as troubleshooting for acute vessel closure due to 
intramural hematoma complication in percutaneous coronary intervention.  
Cardiovasc Interv and Ther 30:3110314 (2015). 
 
16. Jujo K, Saito K, Ishida I, Kim A, Suzuki Y, Furuki Y, Ouchi T, Ishii Y, Sekiguchi H, 
Yamaguchi J, Ogawa H, Hagiwara N.  Intimal disruption affects drug-eluting cobalt-
chromium stent expansion: A randomized trial comparing scoring and conventional 
balloon predilation.  Int J Cardiology 221:23-31 (2016). 
 
17. Cutlip DE, Windecker S, Mehran R, et al. Clinical endpoints in coronary stent trials: 
A case for standardized definitions. Circulation 2007; 115:2344-2351. 
 
18. Thygesen K, Alpert JS, Jaffe AS, et al. Third universal definition of myocardial 
infarction. European Heart Journal 2012;33(20):2551–2567.