A Prospective, Open Label, Non-randomized, Single-Arm, Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA® in Treatment of Patients With Single or Multivessel Coronary Artery Disease (CAD)
Phase: NA
Conditions: Coronary Artery Disease
Sponsor: Spectranetics Corporation

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 1 of 60 
 
 
 
 
 
CLINICAL  INVESTIGATIONAL PLAN 
 
A Prospective, Open label, Non-randomized, Single-Arm, 
Multicenter Study to Evaluate the Procedural Safety and Efficacy of 
ELCA® in Treatment of Patients with Single or Multivessel 
Coronary Artery Disease (CAD) 
 
Protocol Number: ELCA - 1016 
Version 1.0, 12 October 2016  
 
 
SPONSOR 
CONTRACT RESEARCH  ORGANIZATION 
 
Spectranetics Corporation,  
9965, Federal Drive, 
Colorado Springs, 
CO 80921 
Phone: 719-447-2211 
Fax: 719.447.2070 
 
CBCC-Vibgyor Research Pvt. Ltd. 
 
811, Iscon Elegance,  
Opp. Karnavati Club, S. G. Highway , 
Ahmedabad - 380 015, India  
Phone: +91 79 6616 8812/13/14 
Fax: +91 79 6616 8811 
 
 
 
 
 
This study will be conducted in compliance with the Protocol, Good Clinical Practice (GCP) as set forth in the 
International Council for harmonization (ICH) guidelines on GCP (ICH E6) and applicable local regulatory requirements 
 
 
CONFIDENTIAL 
The information in this document is confidential and is to be used only in connection with matters authorized 
by Spectranetics Corporation and no part of it is to be disclosed to others without prior written permission from 
Spectranetics Corporation. 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 2 of 60 
 
1. STUDY CONTACT INFORMATION DETAILS 
Sponsor 
Spectranetics Corporation,  
9965, Federal Drive, 
Colorado Springs, 
CO 80921 
Phone: 719-447-2452 
Email: Amanda.johnson@spnc.com 
Sponsor’s Authorized 
Personnel 
Christopher DeMorett 
Sr. Clinical Manager 
Phone:  719.447.2211 
Fax: 719.447.2070 
E-mail: Christopher.DeMorett@spnc.com 
Clinical Research 
Organization  
CBCC-Vibgyor Research Pvt. Ltd. 
811, Iscon Elegance, Opp. Karnavati Club, S. G. Highway, 
Ahmedabad - 380 015, India  
Phone: +91 79 6616 8812/13/14 
Fax: +91 79 6616 8811 
E-mail: elca@vibgyorcare.com 
Safety Reporting 
CBCC-Vibgyor Research Pvt. Ltd. 
811, Iscon Elegance, Opp. Karnavati Club, S. G. Highway, 
Ahmedabad - 380 015, India  
Phone: +91 79 6616 8812/13/14 
Fax: +91 79 6616 8811 
E-mail: elca@vibgyorcare.com 
2. LIST OF PARTICIPATING INVESTIGATORS 
 
This information will be provided as a separate document. 
 
 
 
 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 4 of 60 
 
4. PROTOCOL SIGNATURE PAGE 
Protocol Title:  A Prospective, Open label, Non-randomized, Single-Arm, Multicenter Study to 
Evaluate the Procedural Safety and Efficacy of ELCA® in Treatment of Patients with Single or 
Multivessel Coronary Artery Disease (CAD) 
Protocol Number: ELCA-1016 
Version and Date: Version 1.0 dated 12 October 2016 
I, the undersigned, have read and understood this protocol and hereby agree to conduct the study in 
accordance with this protocol complying all requirements regarding the obligations of investigators 
and all other pertinent requirements of the Declaration of Helsinki (Ethical principles for medical 
research involving human subjects, revised by the 64th WMA General Assembly, Brazil, October 
2013), which are consistent with the ISO14155 (current version), ICH-GCP guidelines (E6-R1, Step 
5)  along with the local regulatory requirements of GCP for Clinical Research In India (2004, 
CDSCO), Schedule Y (all applicable amendments of  Drug and Cosmetics Rules, 1945) , ICMR 
guidelines for Biomedical Research on Human Subjects (2006). 
I agree to ensure that the confidential information contained in this document will not be used for 
any purpose other than evaluation or conduct of the clinical investigation without the prior consent 
of Spectranetics Corporation. I understand that the Sponsor may decide to suspend or prematurely 
terminate the trial at any time for whatever reason; such a decision will be communicated to me in 
writing. Conversely, should I decide to withdraw from execution of the trial, I will communicate my 
intention immediately in writing to the Sponsor. 
 
I further agree to ensure that all associates assisting in the conduct of this study are well informed 
regarding their obligations and confirm to conduct this study under my direction.  
                
                         ___________________ 
Principal Investigator Signature 
  
 
 
 
            Date 
 
 
 
Principal Investigator Name (Print) 
Address:  
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 5 of 60 
 
5. TABLE OF CONTENTS  
1. 
STUDY CONTACT INFORMATION DETAILS .................................................................. 2 
2. 
LIST OF PARTICIPATING INVESTIGATORS ................................................................... 2 
3. 
SPONSOR’S DECLARATION ................................................................................................. 3 
4. 
PROTOCOL SIGNATURE PAGE .......................................................................................... 4 
5. 
TABLE OF CONTENTS ........................................................................................................... 5 
6. 
STUDY SYNOPSIS .................................................................................................................... 7 
7. 
LIST OF ABBREVIATIONS .................................................................................................. 12 
8. 
STUDY PROCEDURE OVERVIEW ..................................................................................... 14 
9. 
BACKGROUND AND INTRODUCTION ............................................................................ 15 
10. 
INVESTIGATIONAL DEVICE ............................................................................................. 18 
10.1 
DEVICE NAME ......................................................................................................................... 18 
10.2 
MODELS: .................................................................................................................................. 18 
10.3 
INDICATIONS FOR USE ......................................................................................................... 19 
10.4 
DEVICE FAILURE/ MALFUNCTIONS ................................................................................... 21 
10.5 
DEVICE SUPPLY & DEVICE LABELING .............................................................................. 21 
10.6 
DEVICE STORAGE .................................................................................................................. 22 
10.7 
DEVICE ACCOUNTABILITY ................................................................................................. 22 
11. 
RISK BENEFITS EVALUATIONS ....................................................................................... 23 
12. 
CLINICAL INVESTIGATION .............................................................................................. 26 
12.1 
STUDY DESIGN ....................................................................................................................... 26 
12.2 
STUDY POPULATION ............................................................................................................. 26 
12.3 
STUDY DURATION ................................................................................................................. 26 
12.4 
STUDY OBJECTIVES .............................................................................................................. 26 
12.5 
STUDY ENDPOINTS ................................................................................................................ 27 
13. 
CLINICAL INVESTIGATION PROCEDURES .................................................................. 28 
13.1 
SCREEN FAILURE: .................................................................................................................. 28 
13.2 
ENROLLED: .............................................................................................................................. 28 
13.3 
INCLUSION CRITERIA ........................................................................................................... 28 
13.4 
EXCLUSION CRITERIA .......................................................................................................... 29 
13.5 
SCHEDULE AND PROCEDURES ........................................................................................... 30 
13.6 
SCREENING/BASELINE EXAMINATIONS .......................................................................... 31 
13.7 
ANTI PLATELET MEDICATIONS .......................................................................................... 31 
13.8 
TREATMENT PROCEDURE ................................................................................................... 31 
13.9 
POST PROCEDURE ASSESSMENT (UNTIL DISCHARGE) ................................................. 32 
13.10 
SUBJECT FOLLOW-UP ........................................................................................................... 32 
13.11 
CLINIC FOLLOW UP VISIT (30 ± 7 DAYS) ............................................................................ 32 
13.12 
UNSCHEDULED CLINIC VISIT ............................................................................................. 33 
13.13 
UNSCHEDULED CORONARY INTERVENTION ................................................................. 33 
13.14 
SUBJECT LOST TO FOLLOW-UP .......................................................................................... 33 
13.15 
EARLY DISCONTINUATION OF STUDY ............................................................................. 34 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 6 of 60 
 
13.16 
STUDY EXIT ............................................................................................................................. 34 
13.17 
STUDY COMPLETION ............................................................................................................ 34 
13.18 
DATA COLLECTION AND FOLLOW-UP FOR WITHDRAWN PATIENTS ........................ 34 
14. 
ADVERSE EVENT & DEVICE DEFICIENCIES ................................................................ 35 
14.1 
ADVERSE EVENT DEFINITION AND CLASSIFICATION .................................................. 35 
14.2 
ADVERSE EVENT REPORTING............................................................................................. 37 
14.3 
SERIOUS ADVERSE EVENT .................................................................................................. 39 
14.4 
ABNORMAL LABORATORY VALUES OR ABNORMAL CLINICAL FINDINGS ............ 40 
14.5 
SEVERITY OF AN ADVERSE EVENT ................................................................................... 40 
14.6 
CAUSAL RELATIONSHIP OF ADVERSE EVENT ................................................................ 40 
14.7 
ASSESSMENT OF OUTCOME OF ADVERSE EVENTS ....................................................... 41 
14.8 
REPORTING OF SERIOUS ADVERSE EVENTS ................................................................... 41 
14.9 
MEDICAL MONITORING ....................................................................................................... 42 
15. 
STATISTICAL ANALYSIS .................................................................................................... 44 
16. 
QUALITY CONTROL AND QUALITY ASSURANCE ...................................................... 45 
16.1 
INFORMED CONSENT PROCESS .......................................................................................... 45 
16.2 
MONITORING .......................................................................................................................... 45 
16.3 
SOURCE DATA ........................................................................................................................ 46 
16.4 
DATA COLLECTION ............................................................................................................... 47 
16.5 
DATA MANAGEMENT ........................................................................................................... 47 
16.6 
PROTOCOL COMPLIANCE .................................................................................................... 48 
16.7 
PROTOCOL VIOLATIONS ...................................................................................................... 48 
16.8 
PROTOCOL DEVIATIONS ...................................................................................................... 49 
16.9 
PROTOCOL AMENDMENTS .................................................................................................. 49 
16.10 
AUDITS / INSPECTIONS ......................................................................................................... 50 
17. 
REGULATORY REQUIREMENTS ...................................................................................... 51 
17.1 
COMPLIANCE STATEMENT ................................................................................................. 51 
17.2 
ETHICS COMMITTEE/INSTITUTIONAL REVIEW BOARD ............................................... 51 
17.3 
INSURANCE ............................................................................................................................. 52 
17.4 
PATIENT AND DATA CONFIDENTIALITY ......................................................................... 52 
17.5 
RECORDS ................................................................................................................................. 53 
17.6 
RECORD RETENTION............................................................................................................. 54 
17.7 
STUDY TERMINATION .......................................................................................................... 54 
17.8 
INVESTIGATOR REIMBURSEMENT AND CONTRACTING ............................................. 55 
17.9 
RESPONSIBILITIES OF INVESTIGATORS ........................................................................... 55 
17.10 
RESPONSIBILITIES OF SPONSOR AND STUDY MANAGEMENT ................................... 56 
17.11 
CLINICAL STUDY REPORT ................................................................................................... 56 
18. 
PUBLICATION POLICY ....................................................................................................... 57 
19. 
REFERENCES ......................................................................................................................... 58 
20. 
APPENDICES .......................................................................................................................... 60 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 7 of 60 
 
6. STUDY SYNOPSIS  
Title 
A Prospective, Open label, Non-randomized, Single-Arm, 
Multicenter Study to Evaluate the Procedural Safety and Efficacy 
of ELCA® in Treatment of Patients with Single or Multivessel 
Coronary Artery Disease (CAD). 
Trial Location 
India 
Name of the Sponsor 
Spectranetics Corporation 
Protocol Number 
ELCA-1016 
Development phase 
III 
Name of study device 
Excimer Laser Coronary Atherectomy (ELCA®): Coronary Laser 
Atherectomy Catheters (OTW and RX) 
Mode of Application: Invasive 
Stand-alone modality or in conjunction with Percutaneous 
Transluminal Coronary Balloon Angioplasty (PTCA) 
Indication 
Single or Multi vessel Coronary Artery Disease (CAD)  
Objective 
Primary Objective: 
To evaluate the safety and efficacy  of ELCA® in patients with 
single or multivessel CAD either as a stand-alone modality or in 
conjunction with (PTCA),  
Secondary Objectives: 
 
To determine post-procedural TIMI Flow grade 
 
Lesion Morphology 
 
Device-related complications 
 
Procedure-related complications 
Study Endpoints 
Efficacy Endpoint: 
 
Device Success: Successful crossing of the Laser 
Catheter across the entire length of the stenotic lesion  
 
Procedural Success: Target lesions with less than 50% 
residual stenosis after laser and adjunctive therapy. 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 8 of 60 
 
Safety Endpoint:  
 
Freedom from Major Adverse Cardiac Events 
(MACE) through hospital discharge and at one month.  
MACE is defined as Death, Non-Q-wave and Q-wave 
myocardial 
infarction 
(MI), 
Target 
Lesion 
Revascularization, Cardiac Tamponade and Life-
threatening arrhythmias 
 
TIMI Flow 
 
Lesion Morphology 
 
Device-related complications 
 
Procedure-related complications 
Device Failure/ 
Malfunctions 
All failures and malfunctions of the study device must be sent to 
the CRO/Sponsor, preferably within 24 hours of knowledge 
of the event.  
Study design 
Prospective, 
Open 
label, 
Non-randomized, 
Single-arm, 
Multicenter study. 
No. of centers 
Total 05 sites in India. 
The center’s compliance to the clinical investigation plan will be 
assessed on an ongoing basis. In case of serious non-compliance, 
the sponsor may decide to stop patient enrollment in a center 
based on its assessment. 
Sample Size 
30 
Screening & 
Follow Up 
Screening     
Day -10 to 0 
Baseline (study procedure)  
Day 0 
Clinic follow up visit  
30 ± 7 days 
Protocol guided follow-up of patient is vital;   Investigators and 
Site study management team should ensure minimizing follow up 
lapses and to avoid subjects becoming Lost-To-Follow-Up. 
Study Procedure/ 
Methodology 
Each subject will be followed from enrollment through 30 days ± 
7 days for the effectiveness and safety endpoints. 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 9 of 60 
 
Upon enrollment after obtaining a written informed consent, each 
patient will be assigned a unique identification number. Only 
patients eligible to undergo cardiac catheterizations as per routine 
practice will be considered for the study. Premedication of 
patients will be as per the investigator’s routine practice. All 
patient data will be recorded on patient data forms. 
Screening: This will be performed prior to the cardiac 
catheterization procedure. Only patients who have consented and 
fulfill the selection criteria will be enrolled. Additionally, ECG 
and Echocardiogram will be done using hospital equipment to 
ensure fulfillment of inclusion/exclusion criteria. 
Procedure: The entire procedure will be carried out as per the site 
routine practice and the device will be used as per the IFU. 
Clinic follow up visit (30 ± 7 days): The subject will return to 
the clinic at 1 month to evaluate angina status as per the CCS 
classification, AE assessments, concomitant medications and any 
coronary intervention that has occurred since the previous contact. 
An electrocardiogram (ECG) will be repeated during the clinic 
visit. 
Key Inclusion 
Criteria 
The subjects have to meet the following inclusion criteria: 
 
Patient  18 years to 75 years, both inclusive 
 
Have at least one severe stenotic lesion (greater than 
or equal to 80% diameter stenosis as assessed by 
visual estimation) 
 
Hemodynamically stable patients coming to the site 
for cardiac catheterization and angiography who 
fulfill all the following criteria: 
 
Have 
no 
clinically 
significant 
cardiac 
arrhythmias, based on ECG results 
 
Have no evidence of valvular pathology, 
based on echocardiogram results 
 
Have ≥30% left ventricular ejection fraction 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 10 of 60 
 
(LVEF), based on echocardiogram results. 
 
Angiographic evidence of calcification or a chronic 
total occlusion 
 
Vessel reference diameter greater than or equal to 2.0 
mm 
 
Patient is willing and able to comply with study 
requirements 
 
Women of child bearing potential , willing to use at 
least two methods of contraception 
Key Exclusion 
Criteria 
The subjects do not meet any of the following exclusion criteria: 
 
Evidence of acute coronary syndrome within 3 
months prior to index procedure 
 
Evidence of acute ischemic events 
 
Cardiogenic and non-cardiogenic shock 
 
Active bleeding or coagulopathy 
 
Previous coronary angioplasty within 6 months of the 
index procedure 
 
Patients 
participating 
in 
trial 
for 
another 
investigational device/medicine within 1 month prior 
to enrolment in this study 
 
Acute or Chronic renal failure, Impaired renal 
function (serum creatinine > 2.5 mg/dl or 221 mol/l) 
determined within 72 hours prior to index procedure  
 
Known 
allergies 
to 
the 
following: 
Aspirin, 
Clopidogrel or Ticlopidine, Heparin, Sirolimus or its 
derivatives, contrast agent (that cannot be adequately 
pre-medicated), or any metal  
 
Planned surgery within 6 months of enrollment in this 
study 
 
Life expectancy less than 6 months 
 
Patients known to be suffering from substance abuse 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 11 of 60 
 
(alcohol or drug) 
 
Patients with any other significant co-morbid illness 
which in the opinion of the investigator is not 
conducive of inclusion in the study. 
 
Known or suspected Pregnancy  
 
Patients not willing to provide written informed 
consent 
 
In the investigators opinion subjects will not be able 
to comply with the follow-up requirements. 
Data Collection 
All requested data need to be reported by the centers into an 
electronic Case Record Form (eCRF).    
Statistical analysis 
As per the 25th SEC (Cardiovascular & Renal) meeting which 
deliberated the proposals on 30-10-2015 and recommended the 
firm (Spectranetics Corporation - Sponsor) shall conduct a 
Bridging study in Indian Population at least 25 patients. The 
directorate suggested that the sponsor submit a protocol for the 
study in India for clinical trial approval. Considering the 5 
dropouts, Sponsor has set up this protocol to conduct the Excimer 
Laser Coronary Atherectomy (ELCA®) study in India on 30 
eligible patients. 
 
 
 
 
 
 
 
 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 12 of 60 
 
7. LIST OF ABBREVIATIONS 
ACC 
: 
American College Of Cardiology 
AE  
: 
Adverse Event  
AHA 
: 
American Heart Association 
AMI 
: 
Acute Myocardial Infarction 
ASADE 
: 
Anticipated Serious Adverse Device Effect 
CABG 
: 
Coronary Artery Bypass Graft 
CAD 
: 
Coronary Artery Disease 
CBC 
: 
Complete Blood Count 
CCS 
: 
Canadian Cardiovascular Society 
CDSCO 
: 
Central Drugs Standard Control Organization 
CFR 
: 
Code Of Federal Regulations 
CIP 
: 
Clinical Investigational Plan 
CK 
: 
Creatine Kinase 
CRO  
: 
Contract Research Organization  
CRF  
: 
Case Record/Report Form  
CRO 
: 
Clinical Research Orginazation 
CV 
: 
Curriculum Vitae 
DCG(I) 
: 
Drug Controller General Of India 
ECG 
: 
Electrocardiogram 
EDC 
: 
Electronic Data Capture System 
ELCA 
: 
Excimer Laser Coronary Atherectomy 
EOT 
: 
End Of Therapy 
FDA 
: 
Food And Drug Administration 
GCP  
: 
Good Clinical Practice  
ICF  
: 
Informed Consent Form  
ICH  
: 
International Council for Harmonization 
IEC  
: 
Institutional Ethics Committee  
IFU 
: 
Instruction For Use 
IHD 
: 
Ischemic Heart Disease 
IRB 
: 
Institutional Review Board 
ISO 
: 
International Organization Of Standardization 
LARS 
: 
Laser Angioplasty For Restenotic Stents 
LVEF 
: 
Left Ventricular Ejection Fraction 
MACE 
: 
Major Cardiac Adverse Events 
mg 
: 
Milli Gram 
MI 
: 
Myocardial Infarction 
mL  
: 
Milli Litre  
OTW 
: 
Over-The-Wire 
PCI 
: 
Percutaneous Coronary Intervention 
PLLA 
: 
Poly-L-lactic acid 
PTCA 
: 
Percutaneous Transluminal Coronary Balloon Angioplasty 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 13 of 60 
 
RX 
: 
Rapid Exchange 
SAE  
: 
Serious Adverse Event  
SAT 
: 
Sub Acute Thrombosis 
SEC 
: 
Subject Expert Committee 
SOP  
: 
Standard Operating Procedure  
SVG 
: 
Saphenous Vein Bypass Grafts 
TIA 
: 
Transient Ischemic Attack 
TIMI 
: 
Thrombolysis In Myocardial Infarction 
TMF 
: 
Trial Master File 
Trop I 
: 
Troponin I 
ULN 
: 
Upper Limit of Normal 
UPT 
: 
Urine Pregnancy Test 
WMA 
: 
World Medical Association 
 
The following terms will be used synonymously:  
 
 Clinical Investigation Plan (CIP) = Clinical Protocol = Study Plan 
 Clinical Investigation = (clinical) Study = (clinical) Trial 
 CRF = eCRF  
 Study Device = Excimer Laser Coronary Atherectomy (ELCA ®) Products  
 Spectranetics Corporation = Spectranetics = SPNC= Sponsor 
 
 
 
 
 
 
 
 
 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 14 of 60 
 
8. STUDY PROCEDURE OVERVIEW 
 
1 
Blood chemistry includes Complete Blood Count (CBC) and platelet count, serum sodium, potassium, urea, creatinine, and 
Random Blood Sugar (RBS) 
2 
72 hrs prior to the index procedure. 
3 
24 hours prior to index procedure. 
4  
24 hours post procedure 
5 
6 - 24 hours post-procedure or at discharge whichever is earlier. 
6 
Cardiac Markers: If cardiac biomarkers (CK-MB or Trop I) > 3 time Upper Limit of Normal (ULN) or SAT, CK, CK-MB 
& Trop I post procedure, the levels must be evaluated every 8 hours until it returns to normal or until hospital discharge. 
7 
ECG: To be obtained for any suspicious episode of coronary ischemia or SAT during the baseline hospitalization. 
8 
If angiogram is performed during the unscheduled visit, may be collected. 
9 
Urine Pregnancy Test to be performed only for women of child bearing potential, within 72 hours before angiography    
 
 
Procedure 
Screening          
 (Day  -10 to 0) 
Coronary 
Atherectomy 
Post 
Procedure 
Assessment 
30 Days 
Clinic Follow 
Up (± 7 Days)  
Unscheduled 
Visit 
Informed Consent Signed 
X 
 
 
 
 
Assessment of Eligibility Criteria 
X 
 
 
 
 
Review of Medical History 
X 
 
 
 
 
Review of Concomitant Medications  
X 
X 
X 
X 
X 
Physical 
Exam 
Complete 
X 
 
 
 
X 
Angina Class (CCS) 
X 
 
 
X 
X 
Vital Signs 
X 
 
X 
X 
X 
Clinical 
Laboratory  
Chemistry1 
X2 
 
 
 
 
Cardiac Biomarkers  (CK, CK-
MB and Trop I) 
X3 
 
X5,  X6 
 
 
Pregnancy Test 
X9 
 
 
 
 
12 Lead Electrocardiogram (ECG) 
X3 
 
X4 
X7 
X 
LVEF measured through the Echo or LV 
Angiogram 
X2 
 
 
 
 
Coronary Angiogram 
X 
 
 
 
X8 
Device evaluation by Investigators 
 
 
X 
 
 
Adverse Event Assessment 
 
X 
X 
X 
X 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 15 of 60 
 
9. BACKGROUND AND INTRODUCTION 
Ischemic Heart Disease (IHD) has been recognized as a leading cause of death globally. According 
to the most recent health statistics, WHO’s Global Health Statistics 2008, coronary artery 
disease (CAD) will be the number one killer in 2030, causing 14.2% of all deaths worldwide. Acute 
coronary syndrome (ACS) is an acute clinical presentation of CAD; it refers to a range of acute 
myocardial ischemic states.
2,3
It encompasses unstable angina, non-ST segment elevation myocardial 
infarction (ST segment elevation generally absent), and ST segment elevation myocardial infarction 
(persistent ST segment elevation usually present). 
Since its inception in 1977, balloon angioplasty has undergone major improvements but has 
persistent shortcomings in the form of abrupt closure and restenosis. Balloon angioplasty has lower 
success rates in management of long lesions, calcified vessels, bifurcation lesions, saphenous vein 
graft stenosis and ostial narrowings.  It is possible that some of these angiographic characteristics, 
which have been identified as relatively complex by American College of Cardiology /American 
Heart Association ( ACC/AHA) task force may be handled more effectively by a procedure that 
removes atherosclerotic plaque such as excimer laser coronary angioplasty. Studies have reported 
that excimer laser – facilitated coronary angioplasty, in contrast to balloon angioplasty is equally 
successful in treating simple and complex lesions.4 
Atherectomy is a procedure which is performed to remove atherosclerotic plaque from diseased 
coronary and peripheral arterial vasculature. Atherectomy devices are designed to cut, shave, 
sand or vaporize these plaques and have different indications. 
Various available techniques for atherectomy are: 
1. Directional atherectomy where the direction can be adjusted, which is useful for 
eccentric lesions,  
2. Rotational atherectomy where the burr spins concentrically and is mostly used in 
calcified coronaries,  
3. Orbital atherectomy where the crown orbits the wire and is used in both coronary and 
peripheral arterial disease and,  
4. Excimer Laser atherectomy which ablates the tissue and is used in both coronary and 
peripheral arterial disease. 
When excimer laser irradiation is used in the setting of PTCA, the major advantage of this technique 
is thought to be ablation of the atherosclerotic plaque with minimal thermal and mechanical injury 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 16 of 60 
 
to the adjacent vessel wall structures9.  
As opposed to the mandatory fissuring and cracking of the plaque and over distending the arterial 
wall using conventional coronary angioplasty10, laser atherectomy might have the theoretical 
potential of reducing complications and probably as a result of reduced injury, of decreasing the 
incidence of restenosis. 
LASER is an acronym for Light Amplification by Stimulated Emission of Radiation. Although the 
history of laser begins in 1951, the first medical application is reported by Goldman in 1962 and 
used in 1963 for the experimental ablation of atherosclerotic plaques. The first clinical applications 
were performed by Choy and Ginsburg in 1983. 
 
 
 
 
 
 
Figure 1: ELCA® Mode of Action 
 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 17 of 60 
 
Excimer Laser Coronary Atherectomy (ELCA ®) uses the high energy, monochromatic light beam to 
alter or dissolve (vaporize) the plaque without damaging the surrounding tissue. Fiber-optic catheters 
are used to deliver this light beam. For endovascular applications, Xenon Chloride excimer laser is 
used and its fiber-optic catheter has multiple small fibers, rather than just a few large fibers, in order 
to be flexible enough to navigate in the arterial tree. 
Laser can be used in both coronary and peripheral applications. In coronaries, excimer laser can be 
used to remove thrombi; to vaporize pro coagulant reactants in addition to debulking the underlying 
plaque; and to facilitate stent delivery. In the CARMEL multicenter study, excimer laser angioplasty 
was successfully used in more than 90% of the enrolled 151 acute myocardial infarction (AMI) 
patients with a large thrombus burden with a relatively low rate (8.6%) of major cardiac adverse 
events (MACE). It has been also used for in-stent restenosis: in the Laser Angioplasty for Restenotic 
Stents multicenter registry (LARS), laser angioplasty reduced 30-day repeat-target-site coronary 
intervention, but it did not decrease in 1 year. Balloon-resistant lesions, chronic total occlusions, 
calcified lesions, and under expanded stents in calcified lesions are some other scenarios in which 
excimer laser coronary atherectomy can be successfully used. 
The original excimer laser coronary angioplasty (ELCA) devices Model numbers PC1014 and 
PC1017, known as the “Soft Rim” versions were originally submitted to the FDA through the PMA 
approval process in 1991 Submission P910001. The devices were indicated for use in patients with 
single or multivessel coronary artery disease either as a stand-alone treatment or in conjunction with 
percutaneous transluminal coronary angioplasty (PTCA) and in patients who are acceptable 
candidates for coronary artery bypass graft (CABG) disease. These models obtained approval from 
the FDA for use in 1993. CE mark was granted in 1996. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 18 of 60 
 
10. INVESTIGATIONAL DEVICE  
10.1 
DEVICE NAME 
Excimer Laser Coronary Atherectomy (ELCA®) Products  
Excimer Laser Coronary Atherectomy (ELCA®): Coronary Laser Atherectomy Catheters (OTW and 
RX) 
Mode of Application: Invasive 
Stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon 
Angioplasty (PTCA) 
Coronary Laser Atherectomy Catheters (Over-The-Wire [OTW] and Rapid Exchange [RX])  
10.2 
MODELS:  
 110-001 ELCA 0.9mm Extreme OTW Laser Catheter 
 110-002 ELCA 0.9mm 80 Hz Extreme OTW Laser Catheter 
 110-003 ELCA 0.9mm Vitesse  RX Laser Catheter 
 110-004 ELCA 0.9mm 80 Hz Extreme RX Laser Catheter 
 114-009 ELCA 1.4mm Vitesse RX Laser Catheter 
 117-016 ELCA 1.7mm Vitesse RX Laser Catheter 
 120-009 ELCA 2.0mm Vitesse RX Laser Catheter 
 117-205 ELCA 1.7mm Vitesse-E RX Laser Catheter 
 120-008 ELCA 2.0mm Vitesse-E RX Laser Catheter 
ELCA products are percutaneous, single use, disposable medical devices designed for excimer laser 
coronary atherectomy within native coronary arteries and saphenous vein bypass grafts (SVG). 
ELCA products are typically employed, as a precursor treatment or in conjunction with percutaneous 
transluminal coronary angioplasty (PTCA) or percutaneous coronary intervention (PCI) techniques 
that employ balloon catheter dilatation and/or stenting, to reduce, minimize or alleviate flow-limiting 
stenoses or occlusions following placement of a guidewire across the target treatment site.  
ELCA products are approved for use in conjunction with the Spectranetics CVX-300® Excimer 
Laser System (CVX-300) and are intended for use in patients with single or multivessel coronary 
artery disease (CAD) or SVG disease as a stand-alone modality or in conjunction with PCI 
techniques. 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 19 of 60 
 
 
  
 
Figure 2:  ELCACatheter                                             Figure 2:  CVX-300 Excimer Laser  
10.3 
INDICATIONS FOR USE  
ELCA products are typically employed as a precursor interventional treatment for patients 
presenting with a variety of obstructive CAD and SVG indications (e.g., complex lesion patterns, 
subtotal and total occlusions, small vessel disease, resistant lesions, acute thrombosis) and a range 
of comorbid conditions (e.g., coronary insufficiency, acute coronary syndrome, acute myocardial 
infarction, heart failure, arrhythmia). 
ELCA indications for use are based on lesion, stenosis and/or occlusion physical descriptors versus 
the clinical presentation of the patient. The ELCA indications are identical for CE mark (EU) and 
FDA (US) product labeling. The current indications include;  
 
Occluded saphenous vein bypass grafts 
 
Ostial lesions 
 
Long lesions - (greater than 20 mm in length) 
 
Moderately calcified stenoses - (Heavily calcified stenoses are those lesions that 
demonstrate complete calcification when identified under fluoroscopy by angiography prior 
to the procedure. Moderately and slightly calcified stenoses are all others.) 
 
Total occlusions traversable by a guidewire 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 20 of 60 
 
 
Lesions which previously failed balloon angioplasty - (This includes those lesions that were 
treated unsuccessfully by PTCA. Lesions that have undergone a complicated PTCA 
procedure are not included in this category.) 
 
ONLY ELCA, NOT ELCA X-80: Restenosis in 316L stainless steel stents, prior to the 
administration of intravascular brachytherapy. 
Contraindications  
 
Lesion is in an unprotected left main artery.  
 
Lesion is beyond acute bends or is in a location within the coronary anatomy where the 
catheter cannot traverse. 
 
Guidewire cannot be passed through the lesion.  
 
Lesion is located within a bifurcation.  
 
Patient is not an acceptable candidate for bypass graft surgery. 
 
 
 
 
 
 
 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 21 of 60 
 
 
10.4 
DEVICE FAILURE/ MALFUNCTIONS 
In case of device failure or malfunction, Investigator should attempt again with the new study device 
to treat the target lesion.  
All failures and malfunctions of the study device must be sent to the CRO/Sponsor, preferably 
within 24 hours of knowledge of the event. The investigator must return any damaged study device 
to the Sponsor with an explanation of why the study device was opened but unused. All device 
failure and malfunctions will be reported in the Clinical Study Report.  
10.5 
DEVICE SUPPLY & DEVICE LABELING 
Where applicable, the investigational device and its associated components will have a label 
according to ISO14155 (current version) that will be visible on the pertinent shipping cartons and 
storage containers. The required labels or instructions for use (IFU) will bear the following 
information: 
 Name, model and lot number of the Excimer Laser Coronary Atherectomy (ELCA ®) 
Products 
 Name and addresses of the manufacturer and distributor 
 Labeling statement: “FOR CLINICAL INVESTIGATION ONLY” 
 Quantity of contents 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 22 of 60 
 
 All relevant contraindications, hazards, adverse device effects, interfering 
substances or devices, warnings and precautions 
 Expiration date 
10.6 
DEVICE STORAGE 
Store according to Instruction for Use, the study device has to be stored in a cool, dark and 
dry location at maximum temperature of 25 °C. 
10.7 
DEVICE ACCOUNTABILITY 
Access to investigational devices shall be controlled and the investigational devices shall be 
used only in the clinical investigation and according to the CIP. 
The sponsor or designee shall keep records to document the physical location of all 
investigational devices from shipment of investigational devices to the investigation sites 
until return or disposal. The principal investigator or an authorized designee shall complete 
the Investigational Device Accountability Log in order to keep records of the receipt, use, 
return and disposal of the investigational devices, which shall include: 
 Date of receipt 
 Identification of each investigational device (batch/serial number or unique 
code) 
 Expiry date, if applicable 
 Date or dates of use 
 Subjects identification code, if applicable 
 Date on which the investigational device was returned/explanted from subjects, 
if applicable 
 Date of return of unused, expired or malfunctioning investigational devices, if 
applicable 
 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 23 of 60 
 
11. RISK BENEFITS EVALUATIONS 
The risk assessment, to support the safety of Excimer Laser Coronary Atherectomy 
(ELCA®) Product are documented in the previous clinical evaluations of the device. Study 
subjects will be informed of all known potential side effects and complications associated 
with study treatment and evaluations prior to enrollment in the study.   
The treatment will be performed according to routine hospital practice. Excimer Laser 
Coronary Atherectomy (ELCA®) Product is CE mark approved. 
No patient identifier information will be collected during the study. Each patient will be 
assigned a unique identifier via Remote Data Capture system. This information is then 
pooled with all the data for analysis and reporting. 
The risks of using this device in coronary lesions may be similar to risks encountered with 
other marketed stainless steel stents/drug eluting stents/ atherectomy catheter. Excimer 
Laser Coronary Atherectomy (ELCA®) Product is not commercially available in Indian 
market for its use. Information about risk and risk mitigation may include, but is not limited 
to; 
 Cardiac events:  
Myocardial infarction or ischemia, abrupt closure of coronary artery, restenosis of 
treated artery (greater than 50% obstruction), cardiogenic shock, angina, tamponade, 
perforation or dissection of coronary artery or aorta, cardiac perforation, emergency 
cardiac surgery, pericardial effusion, aneurysm formation. 
 Arrhythmic events:  
Ventricular tachycardia, ventricular fibrillation, atrial fibrillation, bradycardia. 
 Respiratory events:  
Acute pulmonary edema, congestive heart failure, respiratory insufficiency or 
failure. 
 Vascular events:  
Access site hematoma, hypotension/hypertension, pseudoaneurysm, arteriovenous 
fistula formation, retroperitoneal hematoma, vessel dissection or perforation, 
thrombosis or occlusion, compromise of side branch patency, vasospasm, peripheral 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 24 of 60 
 
ischemia, dissection, distal embolization (air, tissue debris, thrombus). 
 Neurologic events:  
Permanent (stroke) or reversible (TIA) neurologic event, femoral nerve injury, 
peripheral nerve injury. 
 Bleeding events:  
Access site bleeding or hemorrhage, hemorrhage requiring transfusion or other 
treatment. Allergic reactions to contrast media, antiplatelets, anticoagulants, to the 
drug carrier (PLLA), to Sirolimus and/or Magnesium, Yttrium, Neodymium, 
Zirconium, Gadolinium and Dysprosium. 
 Infection and sepsis. 
 Death. 
The  following  complications  may  be  associated  with  the  use  of  coronary  
stenting devices or PTCA: 
 Allergic reaction to contrast medium 
 Bleeding complications 
 Cardiac tamponade 
 Cerebrovascular accident 
 Dissection of coronary artery 
 Drug reactions to antiplatelet agents, 
anticoagulation agents and/or contrast 
media 
 Emboli, distal (tissue, air or 
thrombotic emboli) 
 Endocarditis 
 Failure to deliver the required 
therapy 
 Fever 
 Hematoma 
 Hemorrhage 
 Injury of the coronary artery 
 Pain and tenderness 
 Pyrogenic reaction 
 Renal failure 
 Emergency CABG 
Based upon the existing experience with the Excimer Laser Coronary Atherectomy 
(ELCA®), it can be concluded that the risks associated with the use of the ELCA® are 
acceptable under the conditions outlined in this study protocol, and that the potential 
benefits may outweigh the risks.  
Moreover, subjects will be monitored closely throughout the clinical investigation duration. 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 25 of 60 
 
Subjects will be evaluated clinically at pre-determined time points to assess their clinical 
status till the end of study. 
Potential Benefits 
Participation in this study is voluntary. Subjects potentially could benefit through the 
procedure of study device, as compared to the routine angioplasty for the patient population 
under consideration in this study. As already mentioned, several studies have shown the 
benefits of standalone ELCA atherectomy and ELCA atherectomy with stent implantation 
has better patient outcome in similar patient population. Information gathered from this 
study will help confirm the safety and performance of the Excimer Laser Coronary 
Atherectomy (ELCA®) in subjects with coronary artery disease (CAD). 
 
 
 
 
 
 
 
 
 
 
 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 26 of 60 
 
12. 
CLINICAL INVESTIGATION 
12.1 
STUDY DESIGN 
This is a Prospective, Open label, Non-randomized, Single-Arm, Multicenter Study to Evaluate 
the Procedural Safety and Efficacy of ELCA® in Treatment of Patients with Single or 
Multivessel Coronary Artery Disease (CAD).  
12.2 
STUDY POPULATION 
Up to 30 patients will be enrolled at up to 05 Indian study sites. Patients will be followed from 
enrollment through 30 days ± 7 days for the effectiveness and safety endpoints at the study 
centre. 
The center’s compliance to the clinical investigation plan will be assessed on an ongoing basis. 
In case of serious non-compliance, the sponsor may decide to stop patient enrollment in a center 
based on its assessment 
12.3 
STUDY DURATION 
Duration of this clinical study is up to 12 months which includes trial set-up, enrollment period, 
study procedures, follow-up visits, data analysis and release of the clinical study report.  
Study will start upon the receipt of the central Indian regulatory authority’s approval as well as 
Ethics Committee approval at respective sites. Up to 30 eligible subjects will be enrolled in the 
study. All subjects will be followed clinically until one month (30±7 days), post-procedure.  
12.4 
STUDY OBJECTIVES 
 
Primary Objective 
To evaluate the safety and efficacy of ELCA® in patients with single or multivessel CAD either 
as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon 
Angioplasty (PTCA).  
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 27 of 60 
 
Secondary Objectives: 
 
To determine post-procedural TIMI Flow grade 
 
Lesion Morphology 
 
Device-related complications 
 
Procedure-related complications 
12.5 
STUDY ENDPOINTS 
Efficacy Endpoint: 
 
Device Success: Successful crossing of the ELCA Catheter across the entire length of the 
stenotic lesion  
 
Procedural Success: Target lesions with less than 50% residual stenosis after laser and 
adjunctive therapy 
Safety Endpoint:  
 
Freedom from major adverse cardiac events (MACE) through hospital discharge and at 
one month 
MACE is defined as Death, Non-Q-wave and Q-wave myocardial infarction (MI), Target 
Lesion Revascularization, Cardiac Tamponade and Life-threatening arrhythmias 
 
TIMI Flow 
 
Lesion Morphology 
 
Device-related complications 
 
Procedure-related complications 
In order to fully characterize the procedure, information of all treated lesions will be collected 
irrespective of whether the lesion has been treated with ELCA® product. 
Electronic Case Report Forms will be utilized to collect relevant information. 
 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 28 of 60 
 
13. CLINICAL INVESTIGATION PROCEDURES 
Up to 30 subjects with documented clinical symptoms, ECG changes and study lesion identified by 
angiography requiring Coronary Atherectomy will be enrolled in this study.  
A written informed consent form will be obtained for enrollment. Each patient will be assigned a unique 
identification number. Only patients eligible to undergo cardiac catheterizations as per routine practice 
will be considered for the study. Premedication of patients will be as per the investigator’s routine 
practice. All data will be captured in Case Record Form. 
13.1 
SCREEN FAILURE:  
There may be a provisionally enrolled subject who withdraws consent prior to the index procedure or is 
unsuitable for the Excimer Laser Coronary Atherectomy (ELCA®) following laboratory 
assessments, pre-procedure ECG or any study specific invasive or non-invasive treatment as pre-
specified in the Clinical Investigation Plan. These subjects will be exited from the study once screen 
failure is confirmed.  Subject informed consent forms will be kept in the site’s administrative files. These 
subjects will not be considered as part of the 30 patients for the analysis. 
13.2 
ENROLLED:  
The investigator must ensure that all patients being considered for the study meet the study criteria (all of 
the inclusion and none of the exclusion criteria). The investigator should apply no additional exclusions, 
in order that the study population will be representative of all eligible patients. Patient selection is to be 
established by checking through all inclusion/ exclusion criteria at screening and baseline. A relevant 
record (e.g. checklist) must be stored with the source documentation at the study site. 
Deviation/Violation from any entry criterion excludes patients from enrollment into the study. 
13.3 
INCLUSION CRITERIA  
Subjects will be enrolled in the study if ALL of the following conditions are met: 
1. Patient 18 years to 75 years, both inclusive 
2. Have at least one severely stenotic lesion (greater than or equal to 80% diameter stenosis as 
assessed by visual estimation) 
3. Haemodynamically stable patients coming to the site for cardiac catheterization and 
angiography for various indications and who fulfill all the following criteria: 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 29 of 60 
 
 
Have no clinically significant cardiac arrhythmias, based on ECG results 
 
Have no evidence of valvular pathology, based on echocardiogram results 
 
Have ≥30% left ventricular ejection fraction (LVEF), based on echocardiogram 
results. 
4. Angiographic evidence of calcification or a chronic total occlusion 
5. Vessel reference diameter greater than or equal to 2.0 mm 
6. Patient is willing and able to comply with study requirements 
7. Women of child bearing potential , willing to use at least two methods of contraception 
13.4 
EXCLUSION CRITERIA 
Subjects will not be enrolled in the study if ANY of the following conditions are present in the subject: 
1. Evidence of acute coronary syndrome within 3 months prior to index procedure 
2. Evidence of acute ischemic events 
3. Cardiogenic and non-cardiogenic shock 
4. Active bleeding or coagulopathy 
5. Previous coronary angioplasty within 6 months of the index procedure 
6. Patients participating in trial for another investigational device/medicine within 1 month prior 
to enrolment in this study 
7. Acute or Chronic renal failure, Impaired renal function (serum creatinine > 2.5 mg/dl or 221 
mol/l) determined within 72 hours prior to index procedure. 
8. Known allergies to the following: Aspirin, Clopidogrel or Ticlopidine, Heparin, Sirolimus or 
its derivatives, contrast agent (that cannot be adequately pre-medicated), or any metal  
9. Planned surgery within 6 months of enrollment in this study 
10. Life expectancy less than 6 months 
11. Patients known to be suffering from substance abuse (alcohol or drug) 
12. Patients with any other significant co-morbid illness which in the opinion of the investigator 
is not conducive of inclusion in the study. 
13. Known or suspected Pregnancy  
14. Patients not willing to provide written informed consent 
15. In the investigators opinion subjects will not be able to comply with the follow-up 
requirements.  

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 30 of 60 
 
13.5 
SCHEDULE AND PROCEDURES  
Prescreening Evaluation, Informed Consent & Enrollment 
The subjects being considered for percutaneous coronary interventions should be pre-screened via a 
general review of inclusion/exclusion criteria without any study related assessment.  
After the subject signed the IRB/IEC approved informed consent, study specific screening assessments 
can be started and the subject is provisionally enrolled. 
Each potential subject who meets the inclusion criteria and has none of the exclusion criteria will be 
explained about the study and study device, informed about the objective, potential risks-benefits and 
alternatives of the study and then invited to voluntarily participate in the study. Subjects will be informed 
about the one month (30±7 days) follow up visit to assess the safety and efficacy endpoints. Investigator 
will answer each questions asked by subject and/or subject’s representative during the informed consent 
process. 
Investigator will give ample time to subject and/or subject’s representative to read and understand the 
informed consent form. If a subject and/or subject’s representative voluntarily agrees to participate in the 
study, subject and/or subject’s representative will sign and date the written subject informed consent 
form prior to   any study procedure. Each subject is free to withdraw from the study at any time during 
the study period. 
Informed consent should be obtained in accordance with the applicable Indian regulations - Schedule Y 
and all applicable amendments (Drugs and Cosmetics Rules, 1945), GCP for Clinical Research in India 
(2001), ICMR guidelines for Biomedical Research on Human Subjects (2006), and current versions of 
Declaration of Helsinki, ICH-GCP and ISO 14155. If a subject might be eligible for the study, the 
investigator or delegated staff should approach the subject to obtain the written informed consent. 
During the consent process the background of the proposed study, the benefits and risks of study 
participation should be explained in detail to the subject.  
It has to be emphasized that a subject's participation in the trial is voluntary and that the subject may 
refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which 
the subject is otherwise entitled. The subject must be given ample time to read the subject information 
and to address questions before signing the consent form. The Patient Information Sheet and a copy of 
the EC approved signed consent form (by investigator and subject) will be handed over to the subject. 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 31 of 60 
 
13.6 
SCREENING/BASELINE EXAMINATIONS 
After signature of the informed consent, the subjects will undergo a baseline examination in order to 
assess their eligibility through the following tests and examinations 
 
Physical examination and relevant medical history, including angina status or myocardial 
ischemia assessment as per Canadian Cardiovascular Society (CCS) Classification, medication 
list, vital signs and subjects demographic information;  
 
Baseline cardiac biomarkers (CK, CK-MB and Trop I) must be obtained 24 hours prior to the 
index procedure;  
 
Routine clinical laboratory testing including Complete Blood Count (CBC) and platelet count 
and blood chemistry include serum sodium, potassium, urea, creatinine, and random blood 
sugar (RBS) must be obtained, 72 hours prior to the index procedure;  
 
For women of child bearing potential, urine pregnancy test  must be performed 72 hours prior 
to the index procedure and it must be negative;  
 
12-lead electrocardiogram must be obtained 24 hours prior to the index procedure. 
 
Documented LVEF through the Echocardiography or LV angiography to assess Left 
Ventricular function 72 hours prior to the index procedure.  
 
Review of inclusion and exclusion criteria 
13.7 
ANTI PLATELET MEDICATIONS 
Before the procedure and in the follow-up period, the subjects will be treated with anti-platelet 
medications, or vasodilators, according to the standard institutional practice. Pre medication & Post 
medication will be recorded in Study Medication Form in eCRF. 
13.8 
TREATMENT PROCEDURE 
The entire procedure will be carried out as per the site routine practice and the device will be used as per 
the ‘Instruction for Use’, available with Excimer Laser Coronary Atherectomy (ELCA®) Products. 
All study investigators and site personnel involved in the clinical trial have to sign the Site Signature and 
Responsibility log (Delegation Log) and provide signed and dated curriculum vitae (CV).  
Treating physicians/ study investigators will be trained by the study Sponsor on the study protocol and 
procedures prior to clinical investigation procedure.  

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 32 of 60 
 
Subject preparation and percutaneous access should be performed according to the standard hospital 
practice. Both femoral and radial accesses are accepted. The procedure begins once percutaneous access 
has been made. 
13.9 
POST PROCEDURE ASSESSMENT (UNTIL DISCHARGE) 
The index procedure will be considered as complete, when the guiding catheter has been removed from 
the subject and the subject has left the cardiac catheterization laboratory. If a guiding catheter is reinserted 
thereafter, it will be considered as a re-intervention. Relevant CRF will be completed for such re-
intervention. Following post procedure parameters will be assessed after the Coronary Atherectomy: 
1. 
Vital Signs 
Subject’s vitals will be assessed immediately post PCI as per the Investigator’s discretion. 
2. 
Laboratory Evaluation 
Cardiac biomarkers (CK, CK-MB and Trop I) will be performed 06-24 hours / or at discharge of post-
procedure whichever is earlier. If the cardiac biomarkers (CK-MB or Trop I) are 3 times above the upper 
limit of normal or incase of Sub Acute Thrombosis (SAT), CK, CK-MB & Trop I must be evaluated 
every 8 hours until it returns to normal or until hospital discharge. 
3. 
Electrocardiogram 
12-lead electrocardiogram will be obtained 24 hours post procedure. Electrocardiograms should also be 
obtained for any episodes suspicious for coronary ischemia or SAT during the baseline hospitalization. 
13.10 SUBJECT FOLLOW-UP 
After study procedure, all enrolled subjects will be followed through hospital discharge and will 
undergo on-site follow-up evaluations at one month (30±7 days).  The investigator may examine the 
subject at any time post-device placement if there is any concern about the device or subject. In addition, 
the investigator will inform the subject and/or subject’s representative that they should report any 
discomfort immediately.  
13.11 CLINIC FOLLOW UP VISIT (30 ± 7 DAYS)  
The subject will return to the clinic at one month (30 ± 7 days) and Study subjects will undergo the 
following clinical evaluation: 
 
Assessment of the ischemic/angina status (CCS, Braunwald or silent ischemia) 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 33 of 60 
 
 
Monitoring and documentation of adverse and serious adverse events, 
 
Documentation of any change to anti-platelet/anti-coagulant medical therapy. 
An electrocardiogram will be repeated during the clinic visit as per the investigator’s discretion. 
13.12 UNSCHEDULED CLINIC VISIT 
If the subject is seen by the investigator between scheduled follow-up visits (not a study required 
visit), unscheduled follow-up CRF must be completed.  The subject will still be required to come for 
the next scheduled follow-up visit if the unscheduled visit is out of the compliance follow-up 
window. If the subject has complications attributable to the study procedure and seeks medical 
advice from the Investigator between scheduled follow-up visits, an Event Reporting CRF must be 
completed in addition to a Follow-up CRF. 
13.13 UNSCHEDULED CORONARY INTERVENTION 
The indication for an unscheduled coronary intervention could be an abnormal electrocardiogram, 
positive exercises test, raised biomarkers or symptoms suggestive of coronary ischemia. Symptoms, 
stress testing and other appropriate evidence should be documented on the relevant CRF. In case of an 
unscheduled coronary angiogram in the follow up period during the study participation, the event must 
be reported on the relevant CRF.  
If the subject is treated by a health-care professional other than the study investigator for treatment 
related to complications, the investigator must request copies of the medical records and, if necessary, 
complete an Event Reporting CRF. 
13.14 SUBJECT LOST TO FOLLOW-UP 
Subjects who do not complete the scheduled follow-up visits and have not officially withdrawn from the 
study are considered lost to follow-up.  If a subject is lost to follow-up, an End of Study CRF must be 
completed and sent to the Sponsor/CRO as soon as possible, after subject status has been determined. If 
a subject fails to comply with follow-up evaluations, the study site must make repeated attempts 
(minimum three attempts) to contact the subject. Each attempt to contact the subject and the method used 
to contact (e.g., telephone contact, registered letter), must be documented in the subject’s records.  

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 34 of 60 
 
13.15 EARLY DISCONTINUATION OF STUDY 
The study may be discontinued/ terminated at any time at the request of the Sponsor, the Ethics 
Committee, Principal Investigator or Regulatory Authority, with appropriate and timely notification to 
all parties concerned, otherwise, the study is terminated upon completion of all enrolled subjects through 
one month (30±7 days) of clinic/angiographic follow-up. 
13.16 STUDY EXIT 
Every subject should be encouraged to remain in the study until they have completed the CIP required 
follow-up period of one month (30±7 days). If a subject prematurely discontinues the study, the reason 
for discontinuation should be documented in Case Report Form (CRF). Possible reasons for premature 
discontinuation may include, but are not limited to the following: 
 
For any reason determined by judgment of the investigator that the subject should no 
longer participate in this trial. 
 
Subject non-compliance with the CIP  
 
Subject lost to follow-up. 
 
Voluntary decision by the subject. 
 
Death  
13.17 STUDY COMPLETION 
Subject who completes all protocol-required study procedures. 
13.18 DATA COLLECTION AND FOLLOW-UP FOR WITHDRAWN PATIENTS 
Investigator will have to follow the patient who has been withdrawn from the study. Investigator should 
try to obtain the reason, if patient withdraws his/her consent. Reason for withdrawal from the study shall 
be documented, whenever possible. It is vital to collect safety data on any patient discontinued because 
of an adverse event (AE) or serious adverse event (SAE). In any case, every effort must be made to 
undertake protocol-specified safety follow-up procedures. If voluntary withdrawal occurs, the patient 
should be asked to continue scheduled evaluations, complete an end-of-study evaluation, and be given 
appropriate care under medical supervision until the symptoms of any AE resolve or the subject’s 
condition becomes stable. 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 35 of 60 
 
14. ADVERSE EVENT & DEVICE DEFICIENCIES  
During the course of this clinical investigation adverse events (AE) might occur.  
Adverse event information will be collected throughout the clinical investigation in the CRF by the 
investigator or designee.  
Any adverse event will be followed until study end. 
14.1 
ADVERSE EVENT DEFINITION AND CLASSIFICATION 
Adverse Events are defined and classified in this section according to the current version of ISO 14155. 
 
Figure 4 – Adverse event definition and classification 
Adapted from ISO 14155 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 36 of 60 
 
AE – Adverse event:  
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. 
Note:  
This definition includes events related to the investigational medical device  
Note:  
This definition includes events related to the procedures involved 
Note: 
For users or other persons, this definition is restricted to events related to investigational 
medical devices 
ADE – Adverse Device Effect: 
An adverse event related to the use of an investigational medical device. 
Note:  
This definition includes adverse events resulting from insufficient or inadequate instructions for 
use, deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device. 
Note:  
This definition includes any event resulting from use error or from intentional misuse of the 
investigational medical device. 
SAE – Serious Adverse Event:  
An adverse event that 
a) led to death, 
b) led to serious deterioration in the health of the subjects, that either resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-subject or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function, 
c) led to foetal distress, foetal death or a congenital abnormality or birth defect 
Note:  
Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a serious adverse event. 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 37 of 60 
 
SADE – Serious Adverse Device Effect:  
An adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 
USADE – Unanticipated Serious Adverse Device Effect:  
Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified 
in the current version of the risk analysis report. 
Note:  
Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, 
severity or outcome has been identified in the risk analysis report. 
Device Deficiencies  
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or 
performance. 
Note:  
Device deficiencies include malfunctions, use errors and inadequate labelling. 
Use error 
Act or omission of an act that results in a different medical device response than intended by the 
manufacturer or expected by the user. 
Note:  
Use error includes slips, lapses, and mistakes. 
Note:  
An unexpected physiological response of the subject does not in itself constitute a use error. 
[ISO 14971:2007, definition 2.27] 
14.2 
ADVERSE EVENT REPORTING  
Adverse events have to be reported in accordance to ISO14155 (current version), Schedule Y and all 
applicable amendments (Drugs and Cosmetics Rules, 1945), GCP for Clinical Research in India (2001, 
CDSCO), ICMR guidelines for Biomedical Research on Human Subjects (2006). 
An adverse event occurring within this clinical trial will only be reported for enrolled subjects, as 
defined above. 
Reporting of adverse events for enrolled subjects will be conducted until either study exit or study 
completion.  
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 38 of 60 
 
According to ISO14155 (current version), the investigator shall: 
 
Record every adverse event and observed device deficiency, together with an assessment 
 
Report to the sponsor or designee, without unjustified delay, all serious adverse events and 
device deficiencies that could have led to a serious adverse device effect; this information 
shall be promptly followed by detailed written reports 
 
Report to the IRB/IEC serious adverse events and device deficiencies that could have led to a 
serious adverse device effect, if required by national regulations or IRB/IEC 
 
Report to regulatory authorities serious adverse events and device deficiencies that could 
have led to a serious adverse device effect, as required by national regulations. 
 
Supply the sponsor, upon sponsor’s request, with any additional information related to the 
safety reporting of a particular event. 
Adverse events classified to be serious and/or with a relation to the investigational device have to be 
reported to Spectranetics Corporation/CRO without unjustified delay after awareness by the investigator 
or by the investigator’s designee.  
Reporting should be done using the Adverse Event Form in the CRF. This report should deliver any 
information available at the time of reporting. Utmost effort has to be made to collect as much 
information as possible during initial reporting. Follow-up information has to be delivered as fast as 
possible to ensure timely completion of the report. 
The investigator is obliged to provide copies of blinded source documents from the medical record, for 
all SAEs and ADEs, as requested by Spectranetics Corporation/CRO. Angiographic films and technical 
worksheets must be sent to Spectranetics Corporation/CRO by courier within 5 business days after 
assessment. 
If additional information or documentation is needed, the clinical project manager / safety officer or 
designee will contact the investigator to retrieve the necessary information. 
Primary contact for reporting Serious Adverse Events: Safety Reporting: 
CBCC-Vibgyor Research Pvt. Ltd. 
811, Iscon Elegance, Opp. Karnavati Club, S. G. Highway, 
Ahmedabad - 380 015, India  
Phone: +91 79 6616 8812/13/14 
Fax: +91 79 6616 8811 
E-mail: elca@vibgyorcare.com 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 39 of 60 
 
14.3 
SERIOUS ADVERSE EVENT  
As per ICH-GCP (E6, step 5) guidelines, serious adverse event (SAE) or serious adverse drug 
reaction is any medical occurrence that at any dose: 
 
No. 
Description 
1 
Results in death 
2 
Is life threatening: refers to immediate risk of death as the event occurred per the 
reporter. A life-threatening event does not include an event that, had it occurred in a 
more severe form, might have caused death but, as it actually occurred, did not create an 
immediate risk of death. For example, hepatitis that resolved without evidence of hepatic 
failure would not be considered life-threatening, even though hepatitis of a more severe 
nature can be fatal. Similarly, an allergic reaction resulting in angioedema of the face 
would not be life-threatening, even though angioedema of the larynx, allergic 
bronchospasm, or anaphylaxis can be fatal. 
3 
Requires inpatient hospitalization or prolongation of existing hospitalization* 
4 
Results in persistent or significant disability/incapacity: is defined as a substantial 
disruption in a person’s ability to conduct normal life functions 
5 
is a congenital anomaly or birth defect 
6 
Is an important medical event: A medical event that may not result in death, be life-
threatening, or require hospitalization may be considered SAEs when, based on 
appropriate medical judgment, they may jeopardize the subject and may require medical 
or surgical intervention to prevent one of the outcomes listed in this definition. Examples 
of such medical events include allergic bronchospasm requiring intensive treatment in an 
emergency room or at home, blood dyscrasias or convulsions that do not result in 
hospitalization, or development of drug dependency or drug abuse. 
 
* Examples of situations which do not fulfill this criterion in the absence of an AE include, but are 
not limited to, are as follows: 
 
A hospitalization or prolongation of hospitalization is needed for a procedure required by 
the protocol 
 
Hospitalization or prolongation of hospitalization is part of a routine procedure followed 
by the site (e.g., stent removal after surgery). This should be recorded in the study file 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 40 of 60 
 
 
A hospitalization for a pre-existing condition that has not worsened 
 
Hospitalization for social reasons 
All SAEs will be recorded on the appropriate SAE form, followed through resolution by the study 
investigator and must be reviewed and evaluated by a study investigator.  
14.4 
ABNORMAL LABORATORY VALUES OR ABNORMAL CLINICAL FINDINGS 
Collection of laboratory data should be limited to those laboratory parameters that are relevant to 
safety, study outcome measures, and/or clinical outcome. Investigator or designee will record and 
report only those abnormal laboratory values, which are clinically significant considering the change 
from the baseline value. 
14.5 
SEVERITY OF AN ADVERSE EVENT 
For evaluating severity of an AE / SAE, following classification will be used to quantify intensity as 
per the clinical judgment of the investigator: 
 
Mild: The event is transient and easily tolerated by the subject. Does not generally warrant 
medical intervention; 
 
Moderate: The event causes the subject discomfort and interrupts the subject’s usual activities. 
May warrant medical intervention; or 
 
Severe: The event usually incapacitating and causes considerable interference with the subject’s 
usual activities. Warrants systemic drug therapy or other treatment Changes in the severity of 
an AE should be documented to allow an assessment of the duration of the event at each level 
of intensity to be performed. Adverse events characterized as intermittent require 
documentation of onset and duration of each episode. 
14.6 
CAUSAL RELATIONSHIP OF ADVERSE EVENT 
The investigator should use his medical judgment to determine the relationship, considering all 
relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, 
confounding factors such as concomitant medication, concomitant diseases and relevant history. 
Assessment of causal relationship should be recorded in the eCRFs and in SAE form (in case of 
SAEs).  
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 41 of 60 
 
The investigator will use the following definitions to assess the relationship of the adverse event to 
the use of study drug: 
No. 
Description 
1 
Unrelated: The Adverse Event is clearly not related to the investigational agent, 
disease, concomitant medication, or other contributing cause. 
2 
Unlikely: The Adverse Event is doubtfully related to the investigational agent, 
disease, concomitant medication, or other contributing cause. 
3 
Possible: The Adverse Event may be related to the investigational agent, disease, 
concomitant medication, or other contributing cause. 
4 
Probable: The Adverse Event is likely related to the investigational agent, disease, 
concomitant medication, or other contributing cause. 
5 
Definite: The Adverse Event is clearly related to the investigational agent, disease, 
concomitant medication, or other contributing cause. 
For causality assessments, events meeting the categories of probable or possible will be considered 
"related."  Events that are reported as unlikely will be considered "not related."   
If an investigator's opinion of possible, probable, or unrelated to study drug is given, another cause 
of event must be provided by the investigator for the serious adverse event. 
14.7 
ASSESSMENT OF OUTCOME OF ADVERSE EVENTS 
The outcome of the AEs will be assessed and recorded as per the following categories: 
 
Recovered/resolved; 
 
Ongoing (Not resolved or stabilized on follow-up); 
 
Recovered with sequelae;  
 
Unknown; 
 
Death. 
14.8 
REPORTING OF SERIOUS ADVERSE EVENTS 
SAE Reporting Requirements according to Indian Regulatory Requirements (Schedule Y):  
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 42 of 60 
 
Investigator’s Responsibility 
 
Investigator(s) shall report all serious adverse events to the Licensing Authority defined under 
clause (b) of rule 21(Drug & Cosmetics rules, 1945), the Sponsor or his representative, 
whosoever had obtained permission from the Licensing Authority for conduct of the clinical 
trial, and the Ethics Committee that accorded approval to the study protocol, within twenty four 
hours of their occurrence. 
 
In case, the Investigator fails to report any serious adverse event within the stipulated period, he 
shall have to furnish the reason for the delay to the satisfaction of the Licensing Authority along 
with the report of the serious adverse event.  
 
The report of the serious adverse event, after due analysis, shall be forwarded by Investigator to 
the Licensing Authority  as referred  to in clause (b) of rule 21(Drug & Cosmetics rules, 1945), 
the Chairman of the Ethics Committee and the Head of Institution where the trial has been 
conducted within fourteen days of the occurrence of the serious adverse event.   
Sponsor’s Responsibility  
 
Any report of the serious adverse event, after due analysis shall be forwarded by the sponsor or 
designee to the Licensing Authority (DCGI) as referred to in clause (b) of rule 21, the Chairman 
of the Ethics Committee and the head of the institution where the trial has been conducted, 
within fourteen days of the occurrence of the serious adverse event. 
Ethics committee that accorded approval for the protocol will send its review report to DCGI for all 
SAEs within 30 days of its occurrence.  
The above mentioned process and timelines for initial SAE reporting will also be followed for 
reporting of all follow-up information received for the SAE.    
In the event of a SAE, the investigator will notify / contact the Medical Monitor. Additionally, 
detailed safety reporting procedures will be described in safety management plan for the study.  
The further course of action for all SAEs; shall be observed as per current local applicable rules and 
regulations. 
14.9 
MEDICAL MONITORING 
It is the responsibility of the investigator to oversee the safety of the study at his/her site. This safety 
monitoring will include careful assessment and appropriate reporting of AEs as noted above, as well 
as the construction and implementation of site data and safety-monitoring plan. For any subject 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 43 of 60 
 
safety or eligibility concerns or protocol related queries, the investigator should contact the sponsor’s 
medical monitor.  
Detailed medical monitoring procedures will be described in the relevant section of the project 
management plan. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 44 of 60 
 
15. STATISTICAL ANALYSIS 
As per the 25th SEC (Cardiovascular & Renal) meeting which deliberated the proposals on 30-10-
2015 and recommended the firm (Spectranetics Corporation - Sponsor) shall conduct a Bridging 
study in Indian Population at least 25 patients. The directorate suggested that the sponsor submit a 
protocol for the study in India for clinical trial approval. Considering the 5 dropouts, Sponsor has set 
up this protocol to conduct the Excimer Laser Coronary Atherectomy (ELCA®) study in India on 30 
eligible patients. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 45 of 60 
 
16. QUALITY CONTROL AND QUALITY ASSURANCE 
All sites conducting research under the sponsorship of the Spectranetics Corporation are required 
to have a plan in place for assuring the quality of the research being conducted.  Each site should 
have standard operating procedures (SOPs for clinical trial activities) and methods of training for 
staff should be specified. 
16.1 
INFORMED CONSENT PROCESS 
The investigator or a person designated by the investigator should completely inform the patients 
and/or their families describing this study and study related procedures providing sufficient 
information to them for making an informed decision about their participation in this study. 
All the patients should be informed to the complete extent possible about the study, in language and 
terms they are able to understand.  Consent form must be IRB/IEC approved and the patient will be 
provided the same in local language(s).       
 
 
Prior to patient’s participation in this study, the written informed consent form must be signed, name 
filled in and personally dated by the patient or by the patient’s legally acceptable representative / 
impartial witness (along with patient’s thumb impression in case when he/she is illiterate) and by the 
person who conducted the informed consent discussion.  A copy of the signed and dated written 
informed consent form will be provided to the patient. 
16.2 
MONITORING  
Monitoring will be performed by Sponsor or Sponsor designees, to ensure that the investigator and 
the clinical investigation team conduct the clinical investigation in accordance with the CIP, current 
versions of Declaration of Helsinki, ISO 14155, International conference of harmonization-Good 
clinical practice (ICH-GCP) and applicable Indian regulations (Schedule Y and all applicable 
amendments - Drugs and Cosmetics Rules, 1945), GCP for Clinical Research in India (2004, 
CDSCO), ICMR guidelines for Biomedical Research on Human Subjects (2006).) to ensure 
adequate protection of the rights, safety and wellbeing of subjects and the quality and integrity of the 
resulting data. 
Periodic monitoring visits will assure that the facilities are still acceptable; that the CIP is being 
followed, that the IEC/IRB has been informed about approved CIP changes as required, that records 
on study conduct and data collection are complete and present, that appropriate and timely reports 
have been made to the sponsor and the authorities, that device inventory is controlled, and that the 
investigator is carrying out all agreed activities.  

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 46 of 60 
 
During monitoring visits, 100% Patient informed consents and 100% source data related to inclusion 
exclusion criteria, Primary and secondary  endpoints and AE and SAEs  will be verified  as defined 
in the monitoring plan. For this purpose, the investigator must permit access to medical records of 
the subjects (source data) throughout the study. In case of electronic medical records, the 
investigator has to ensure that the monitor receives access or print outs of all study relevant source 
documents. The documents must be signed and dated by the investigator or other designated staff. 
If a monitor becomes aware that an investigator is not complying with the requirements as outlined 
in the CIP, the monitor is obliged to notify Sponsor or Sponsor designees for the study management. 
Sponsor or Sponsor designees will evaluate the non-compliance and issue corrective actions, 
discontinue enrollment or as a last measure close the clinical investigation site. The investigator 
must in such case return all unused devices to Sponsor or Sponsor designees. 
16.3 
SOURCE DATA  
Original or signed and dated copies of all clinical findings, observations, and other activities 
throughout the clinical investigation must be recorded and maintained in the medical file of each 
enrolled subject. For data documented in the CRF respective source data in the medical record 
(source document) must be available.  
The medical record/subjects record (source document) must contain, but is not limited to: 
 
Executed informed consent  
 
Subjects participation in the clinical investigation  
 
Demographics 
 
Documentation of medical history 
 
Intervention report 
 
Vessel and lesion sizes and characteristics 
 
All angiographies, ECGs, laboratory examination outcomes including reference values 
 
Discharge letter 
 
All adverse events: diagnosis, symptoms, onset date, severity, device and procedure 
relationship, action taken, outcome 
 
Concomitant medication 
 
Follow-up information 
 
Date of clinical investigation completion 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 47 of 60 
 
16.4 
DATA COLLECTION 
The investigator or an individual designated by the investigator is responsible for recording 
all data from the study in the electronic Case Report Form (CRF).    
The data will be entered in an electronic Case Record Form (CRF), compliant with the 21 
CFR Part 11. The site staff must be trained on CRF completion before they are given access 
for data entry. Data should be entered within 7 days of the study visit and the data queries 
should be responded to promptly. All CRF pages must be electronically signed by the 
investigator or a person designated by the investigator at each site. 
Subjects will be identified in the CRFs by a unique reference number only, a composition of 
letters and numbers. CRFs are confidential documents and will only be available to Sponsor 
(including Sponsor designees), the investigator, the clinical investigation statistician, and the 
regulatory authorities. The investigator or a person designated by the investigator will 
maintain subject identification log of the subjects participating in the clinical investigation at 
the clinical investigation site which will be maintained in the Investigative site file. 
16.5 
DATA MANAGEMENT 
The data manager is responsible for providing a clean data set at the end of the clinical investigation.  
Queries should be resolved by the investigator or a person designated by the investigator in a timely 
manner. Data snapshots will be taken for interim analysis. When all data is complete, the database 
will be locked and data will be analyzed. 
After the data have been entered and verified, various edit checks will be performed for the purpose 
of ensuring the accuracy, integrity, and validity of the database against the CRFs. These should 
include: 
 
Missing value checks 
 
Range checks 
 
Consistency checks 
 
Sequence checks 
 
Probabilistic checks and 
 
Protocol adherence checks 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 48 of 60 
 
All data will be entered into the EDC system. When the database is complete and accurate, it will be 
locked. Any changes to the database after that time can only be made by joint written agreement 
between the sponsor or Sponsor’s designee, the Trial Statistician and the Data Manager. 
It is the responsibility of the study site and investigator to resolve all data queries that arise during 
data management in a timely manner. 
16.6 
PROTOCOL COMPLIANCE 
The investigator is required to conduct the study in accordance with the signed investigator 
agreement and clinical protocol.  
The investigator shall notify Sponsor or Sponsor’s designee and the reviewing IRB/IEC in writing, 
no later than 5 working days after any significant violations from the study plan, conducted to 
protect the life or physical well-being of a subject in an emergency. Except in such emergency, prior 
approval by Sponsor or Sponsor’s designee and, if applicable, IRB/IEC approval is required for 
significant violations from the study plan. Such an approval will be documented in writing and 
maintained in the study files. 
Sponsor or Sponsor’s designee categorizes instances of protocol non-compliance as either violations 
or deviations. 
16.7 
PROTOCOL VIOLATIONS 
Protocol violations are defined as instances where the protocol requirements and/or regulatory 
guidelines were not followed and are generally more serious in nature. Protocol violations are 
considered to potentially affect the scientific soundness of the study and/or the rights, safety or 
welfare of subjects. 
Protocol violations include, but are not limited to: 
 
Failure to obtain informed consent 
 
An unapproved (Sponsor or Sponsor’s designee and IRB/IEC) investigator using Excimer 
Laser Coronary Atherectomy (ELCA®) products for study purposes 
 
Violation of relevant inclusion/exclusion criteria 
 
Protocol requirement violations that affect the primary endpoints analysis 
In some instances, compliance issues with the consent process may occur. The investigator should 
seek guidance from the site’s IRB/IEC to ensure the subject received appropriate information to 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 49 of 60 
 
consider their participation in the study. The investigator is obliged to take any action the IRB/IEC 
feels is necessary, including subjects removal from the study. Please note that subjects who haven’t 
signed informed consent prior to implantation will not be included in the study analysis, even if 
informed consent could be obtained retrospectively.  
All violations will be reported to the competent authority in accordance with applicable regulatory 
timelines. The study site should report the protocol violation to the reviewing IRB/IEC and provide a 
copy of the notification to Sponsor or Sponsor’s designee. The site should also report the protocol 
violation to Sponsor or Sponsor’s designee on the applicable CRF. 
16.8 
PROTOCOL DEVIATIONS 
Protocol deviations are defined as instances where protocol requirements are not followed in such a 
manner whereby data is unusable or unavailable.   
Protocol deviations are less serious in nature and do not require IRB/IEC notification, as long as they 
do not have an effect on the rights, safety or welfare of the study subjects. 
Protocol deviations include, but are not limited to: 
 
Procedure not performed within the allowed follow-up window 
 
Required data not obtained 
 
Follow-up procedure performed at an unapproved location 
The study site should report the protocol deviation on the applicable CRF. 
16.9 
PROTOCOL AMENDMENTS 
Any change or addition to the protocol, other than administrative ones (i.e. typographical or 
logistical), can  only  be  made  in  a  written  protocol  amendment that  must  be  approved  by 
Sponsor, DCGI where required, and the IRB/IEC. Only amendments that are required for patient 
safety may be implemented prior to IRB/IEC approval. 
Notwithstanding the  need  for  approval  of  formal  protocol  amendments,  the  investigator  is 
expected to take any immediate action required for the safety of any patient included in this study, 
even if this action represents a violation of the protocol. In such cases, CRO and Sponsor should be 
notified of this action and the IRB/IEC at the study site should be informed within 7 working days. 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 50 of 60 
 
Changes to the protocol affecting only administrative aspects of the study do not require formal 
protocol amendments or IRB/IEC approval but the IRB/IEC must be kept informed of such 
administrative changes. Examples of administrative changes not requiring formal protocol 
amendments and IRB/IEC approval that can be treated as administrative amendments include: 
 Changes in the staff used to monitor trials 
 Changes in shipping address for CRFs 
16.10 AUDITS / INSPECTIONS 
Study centre’s may be audited during the course of and after completion of the clinical investigation 
by Sponsor or Sponsor’s designee, IRB/IEC, competent authority or other applicable regulatory 
authorities.  
The investigator must provide the auditors/inspectors with all clinical investigation documents 
including the medical records for all enrolled subjects.  
Sponsor or Sponsor’s designee will evaluate any non-compliance and issue corrective actions, 
discontinue enrolment or at last measure close the clinical investigation site 
 
 
 
 
 
 
 
 
 
 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 51 of 60 
 
17. REGULATORY REQUIREMENTS 
17.1 
COMPLIANCE STATEMENT 
The clinical trial will be conducted as per the principles and requirements of Declaration of Helsinki 
(Ethical principles for medical research involving human subjects, revised by the 64th WMA General 
Assembly, Brazil, 2013), and ICH-GCP (E6-R1, Step 5) guidelines along with the local regulatory 
requirements of Good Clinical Practices for Clinical Research in India (2001, CDSCO) ICMR 
guidelines for Biomedical Research on Human Subjects (2006) and Schedule Y  (all applicable 
amendment) and ISO 14155 (current version). 
17.2 
ETHICS COMMITTEE/INSTITUTIONAL REVIEW BOARD  
The clinical investigation plan as well as other relevant study documents required will be submitted 
for approval by the IRB/IEC and DCGI (Drug Controller General of India, CDSCO) competent 
authority of India prior to study start.  
Sponsor or each participating institution/hospital must provide this protocol (protocol amendment, if 
applicable) and essential documents for the review and approval to Institutional Ethics Committee 
(IEC) or Institutional Review Board (IRB), Registered with DCGI, for the formal approval of the 
study conduct. The decision of the IEC/IRB signed by its chairman with IEC composition, 
concerning the conduct of the study will be made in writing to the investigator and a copy of this 
decision will be provided to the sponsor before commencement of this study.  The investigator 
should provide a list of IEC/IRB members and their affiliation to the sponsor. All major amendments 
to the CIP, ICF, or other written information provided to subjects, and/or study procedures directly 
affecting the subject, must be approved in writing by the respective site IEC/IRB. The Investigator 
shall report in writing to the IEC/IRB, any SAE and SADE whether procedure related or not, 
according to the IEC/IRB required timelines, but no longer than 7 days after the investigator is aware 
of event(s) occurrence. 
If requested, a progress report during the trial and a final study report at the end of the clinical trial 
will be submitted to the IEC/IRB.     
Sponsor or Sponsor’s designee will record changes to the clinical investigation plan in amendments. 
Amendments will be submitted to the involved IRB/IEC and respective competent authorities as 
applicable according to international or local regulations. Investigators and study personnel will be 
trained on all amendments. 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 52 of 60 
 
All subjects must be provided with a written informed consent which is approved by the site’s 
IRB/IEC. Sponsor or Sponsor’s designee will provide a master English informed consent form and 
subject information sheet to be used in the study. Each site must provide Sponsor or Sponsor’s 
designee with a copy of the clinical site’s IEC/IRB approval letter or vote and the IRB/IEC approved 
informed consent. The approval letter must specify the documents for which approval has been 
granted. Otherwise it is the obligation of the investigator to inquire about a new document giving the 
necessary details. In addition the composition of the IRB/IEC and a statement about its compliance 
to GCP is required. Approvals for the continuation of the trial at each clinical site must be kept 
current and notifications forwarded to Sponsor or Sponsor’s designee. 
17.3 
INSURANCE 
Subjects who participate in this study will be insured for study related injury according to local 
regulatory requirements. Sponsor or Sponsor’s designee will organize appropriate insurance 
coverage which will be available throughout the entire study.  
The sponsor certifies that it has taken a liability insurance policy covering this clinical trial . The 
insurance policy is in accordance with local laws and requirements. A copy of the insurance 
certificate will be provided to the IEC/IRB.  
17.4 
PATIENT AND DATA CONFIDENTIALITY 
Patient confidentiality along with the information disclosed/provided/produced  during the clinical 
trial, including, but not limited to the CRFs, ICFs and results are strictly held in trust by the sponsor, 
sponsor’s authorized personnel, investigators and their staff members. Subjects will not be identified 
by any personal identity and name in any published study reports. 
No information concerning the study or the data will be released to any unauthorized third party 
without prior written approval of the sponsor. 
The study monitor or other authorized representatives of the sponsor may inspect all documents and 
records required to be maintained by the investigator, including but not limited to, medical records 
(office, clinic, or hospital) and pharmacy records for the subjects in this study. The clinical study site 
will permit direct access to such records. 
The submission of this clinical trial protocol and other necessary documentation to the ethics 
committee (IEC/IRB) is expressly permitted, the IRB/IEC members having the same obligation of 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 53 of 60 
 
confidentiality. Subject’s confidentiality will be maintained throughout the study. It will be ensured 
that the information can always be tracked back to the source data, if required. For this purpose, a 
unique subject identification code (i.e. subject number) will be used that allows identification of all 
data reported for each subject. 
Data relating to the study might be made available to third parties (e.g. in case of an audits or 
regulatory inspections) preconditioned that the data are treated confidentially and that the subject’s 
privacy is guaranteed. 
17.5 
RECORDS 
Records to be maintained by the investigator include, but are not limited to: 
 
Clinical trial investigational plan/Protocol and all amendments 
 
Investigators Brochure or equivalent document 
 
Contact list sponsor/study site 
 
Signed clinical trial agreement 
 
IRB/IEC correspondence, approval letter, including informed consent 
 
IRB/IEC membership list 
 
Regulatory authority notification, correspondence and approval 
 
Insurance certificate 
 
If applicable, device shipping records, device accountability 
 
Correspondence relating to the trial 
 
CVs for all investigators and key members of the investigation site team 
 
Training records 
 
Site personnel signature list and delegation of authority form 
 
Blank set of CRFs and instructions for completion 
 
Subjects screening/enrollment log 
 
Subjects identification log 
 
Lab certification and lab test normal ranges 
 
Adverse event forms 
 
Applicable study logs & forms 
 
Reports (including interim reports, final reports from investigator and sponsor)  

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 54 of 60 
 
Sponsor or Sponsor’s designee will retain relevant study documentation in the Trial Master File 
(TMF) according to national legislation and Sponsor or Sponsor’s designee Standard Operating 
Procedure (SOPs).  
17.6 
RECORD RETENTION  
All study records and reports will remain in file at the sites for a minimum of 3 years after 
completion of the trial and will further be retained in accordance with local and international 
guidelines as identified in the clinical trial agreement.  
The investigator must contact Sponsor or Sponsor’s designee before destruction of any records and 
reports related to the clinical investigation. Sponsor or Sponsor’s designee must be informed if the 
investigator plans to leave the clinical investigation site. In such case the site must name a new 
contact person before the investigator parts from the clinical investigation site. 
17.7 
STUDY TERMINATION  
Sponsor or Sponsor’s designee will monitor the progression of the clinical investigation. If 
warranted, the clinical investigation may be suspended or discontinued early if there is an 
observation of serious adverse reactions presenting an unreasonable risk to the clinical investigation 
population. 
Sponsor or Sponsor’s designee may terminate investigator and site participation in the clinical 
investigation if there is evidence of failure to maintain adequate clinical standards, failure to comply 
with the clinical investigational plan, fraud or any other forms of misconduct. 
In the event of clinical investigation termination or suspension, Sponsor or Sponsor’s designee will 
send a report outlining the circumstances to the corresponding IRB/IEC, regulatory authority and all 
investigators. A suspended or terminated clinical investigation may not be re-initiated without 
approval of the corresponding IRB/IEC and regulatory authority. 
Reasons for termination include, but not limited to, following:  
a) Any clinical adverse event (AE), laboratory abnormality, situation occurs such that continued 
participation in the study would not be in the best interest of the patients. 
b) The study can be terminated if the aim of the clinical trial has become out dated or is no 
longer of interest.   

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 55 of 60 
 
c) If the investigator has received from the sponsor all study drugs, means and information 
necessary to perform the clinical trial and has not included any subject after a reasonable 
period of time mutually agreed upon, site can be prematurely closed. 
d) If the sponsor is not scientifically convinced regarding results of the clinical trial, it may 
close-out the site pre-maturely. 
e) The site can be prematurely closed  if there is an event of breach by the investigator of the 
fundamental obligation under this agreement, including but not limited to breach of the 
clinical trial protocol, breach of the applicable laws and regulations or breach of the 
applicable guidelines for GCP. 
f) Additionally, IRB/IEC can terminate the study for the safety of subjects. 
Subsequent review of serious, unexpected, and related AEs by the medical monitor, IEC/IRB, the 
sponsor(s), or local regulatory authorities may also result in suspension of further trial 
interventions/administration of study product at a site. The study sponsor(s) retain the authority to 
suspend additional enrollment and study interventions/administration of study product for the entire 
study, as applicable. 
17.8 
INVESTIGATOR REIMBURSEMENT AND CONTRACTING  
Sponsor or Sponsor’s designee will reimburse efforts undertaken for inclusion and follow up of 
subjects, and documentation of subject data within the study. A contract (Clinical Trial Agreement) 
with the principal investigator and/or the respective hospital will be agreed on and signed prior to 
study start. Within this an overall fee per subjects broken down to individual visits will be included. 
This subject fee will cover all expenses for material used and procedures to be performed according 
to the CIP. The CIP and any future changes thereof will be part of the contract. 
17.9 
RESPONSIBILITIES OF INVESTIGATORS 
The investigator(s) undertake(s) to perform the clinical trial in compliance and accordance with this 
clinical trial protocol and pertinent requirements of guidelines and regulations.  The investigator 
agrees to provide reliable data and all information requested by the clinical trial protocol (with the 
help of CRF, DCF or other appropriate mode of communication) in an accurate and legible manner 
according to the instructions provided and to ensure direct access to source documents by sponsor 
representatives.  The investigator may appoint such other individuals as he/she may deem 
appropriate as sub-investigators to assist in the conduct of the clinical trial in accordance with the 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 56 of 60 
 
clinical trial protocol.  All sub-investigators shall be appointed and listed in a timely manner.  The 
sub-investigators will be supervised by and under the responsibility of the investigator.  The 
investigator will provide them with a copy of the clinical trial protocol and all necessary information.   
17.10 RESPONSIBILITIES OF SPONSOR AND STUDY MANAGEMENT  
The sponsor of this clinical trial is responsible for taking all reasonable steps to ensure the proper 
conduct of the clinical trial protocol as regards of ethics, clinical trial protocol compliance, and 
integrity and validity of the data recorded on the CRFs. Thus, the main role of the clinical 
monitoring team is to help the investigator and the sponsor in maintaining a high level of ethical, 
scientific, technical and regulatory quality in all aspects of the clinical trial.  
The detailed Project Management Plan, incorporating monitoring plan, safety management plan, IP 
(Investigational  Product) management plan will be generated outlining further management of the 
study related activities of sponsor and CRO. 
17.11 CLINICAL STUDY REPORT 
A final clinical study Report will be prepared according to the Schedule Y Appendix II and ICH 
guideline on structure and content of Clinical Study Report. A Final Clinical study Report will be 
prepared regardless of whether the study is completed or prematurely terminated.  
 
 
 
 
 
 
 
 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 57 of 60 
 
 
18. PUBLICATION POLICY 
It is the responsibility of Sponsor or Sponsor’s designee to register this trial in an acceptable registry. 
On the basis of the statistical and clinical evaluation of the pooled results across the study centers, a 
clinical study report will be prepared by Sponsor or Sponsor’s designee. This can form the basis of a 
manuscript for publication in a peer-reviewed journal. The sponsor will hold the right to publish the 
results of present study at any time.  
Sponsor or Sponsor’s designee intends to publish the results of this clinical investigation. Sponsor or 
Sponsor’s designee reserves the right to include the report of this clinical investigation in any 
regulatory documentation or submission or in any informational materials prepared for the medical 
profession. The ownership of the data shall at all times be held by Sponsor or Sponsor’s designee.  
No publication of results from single center experience will be allowed until the primary endpoint is 
analysed in order to allow for preparation and publication of the multicentre results.  
Sponsor or Sponsor’s designee agrees that investigators shall be permitted to present at symposia, 
national or regional professional meetings, and to publish in journals, theses or dissertations, or 
otherwise of their own choosing, methods and results of the clinical investigation after the first 
publication. Any prior publication in any way or form is not permitted, without approval by Sponsor 
or Sponsor’s designee.  
The investigator should provide Sponsor or Sponsor’s designee with a copy of any publication in 
journals, theses or dissertations at least 4 weeks prior to submission. 
 
 
 
 
 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 58 of 60 
 
19. REFERENCES 
1. Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global and regional burden of 
disease and risk factors, 2001: systematic analysis of population health data. Lancet 2006; 367: 
1747–1757. 
2. Executive Summary of the Third Report of the National Cholesterol Education Program 
(NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In 
Adults (Adult Treatment Panel III). JAMA 2001; 285: 2486–2497. 
3. Fava S, Azzopardi J, Agius-Muscat H. Outcome of unstable angina in patients with diabetes 
mellitus. Diabet Med 1997; 14: 209 –213 
4. Cook SL, Eigler NL, Shefer A, Goldenberg T,Forrester JS, Litvac F :Percutaneous excimer 
laser angioplasty of lesions not ideal for balloon angioplasty.Circulation 1991;84:632-643 
5.  Sanborn TA,Bittl JA,Siegel RM.Kramer BL,Tcheng JE,Poer J:Lack of effect of lesion severity 
on clinical success and complication rates with percutaneous excimer laser coronary 
angioplasty ( Abstract ) Circulation 1991;84 ( suppl II):II-362) 
6. Excimer laser recanalization of femoropopliteal lesions and 1-year patency: results of the 
CELLO registry. 
7. Dave RM, Patlola R, Kollmeyer K, Bunch F, Weinstock BS, Dippel E, Jaff MR, Popma J, 
Weissman N, CELLO Investigators 
8. J Endovasc Ther. 2009 Dec; 16(6):665-75. [PubMed] [Ref list] 
9. Grundfest WS, LitvackF, Forrester JS, et al. Laser ablation of Human Artherosclerotic plaque 
without adjacent tissue injury. Jam Coll Cardiol 1985;5:929-33 
Isner JM, Gal D, Steg PG et al. Percutaneous in vivo excimer laser angioplasty; results in two 
experimental animal model. Lasers Surg Med 1988;8:223-32   
10. Waller BF, Pathology of new intervention used in the treatment of coronary heart disease. Curr 
Probl Cardiol 1986;11:665-760 
Stele PM, Chesebro JH, Stanson AW, et al. Balloon Angioplasty Natural history of the 
pathophysiological response to the injury in a pig model. Cirs Res 1985;57:105-12 
11. World Medical Association Declaration of Helsinki: ethical principles for medical research 
involving human subjects. JAMA 2013 November 27;310(20):2191-4. 
12. ICH-GCO Topic E6, Guideline for Good Clinical Practice, 2002.   
13. International Standard ISO 14155:2011; Clinical investigation of medical devices for human 
subjects - Good clinical practice.   
14. Clinical Investigations: Serious Adverse Event Reporting Under Directives 90/385/EEC AND 
93/42/EEC. MEDDEV 2.7/3 revision 3. May 2015. 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 59 of 60 
 
15. Schedule Y (Part of Drug & Cosmetic Rule 1945, and Amended 2005) and all amendments 
16. Good Clinical Practices for Clinical Research in India Amended Version 2001. 
17. Ethical Guideline for Biomedical Research on Human Participants, ICMR Guidelines, October 
2006. 
18. Spectranetics – Final Clinical Evaluation Report, MEDDEV 2.7.1 (M5), dated 17 August 2015 
19.  Spectranetics – Final Clinical Evaluation Report, MEDDEV 2.7.1 (M5), dated 10 February 
2016 
20. ELCA – Instruction For Use for OTX & RX Catheter Models 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Spectranetics Corporation 
 
 
 
Study Protocol Number: ELCA-1016 
Version 1.0   
   Dated: 12 Oct 2016 
 
Confidential  
 
Page 60 of 60 
 
20. APPENDICES 
 
 SPNC_ELCA STUDY : Patient Information Sheet And Informed Consent 
Form