A Prospective Multi-Centre Registry of EvroSure (Everolimus Drug Eluting CoCr Coronary Stent) to Investigate Safety and Effectiveness Name of Study: EverGreen
Phase: PHASE4
Conditions: Coronary Arterial Disease (CAD)
Sponsor: Frisch Medical Device Private Limited

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A Prospective Multi-Centre Registry 
of EvroSure (Everolimus Drug 
Eluting CoCr Coronary Stent) 
to Investigate Safety and Effectiveness 
 
 
 
Name of Study: EverGreen 
PROTOCOL 
 
 
 
 
 
 
 
The information contained in this protocol is CONFIDENTIAL and PROPRIETARY. It may not be 
provided to any third party except as outlined in this protocol without the written consent of Frisch 
Medical Devices Pvt. Ltd. 

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PROTOCOL APPROVAL PAGE
Registry title: A Prospective Multi-Centre Registry to Investigate Safety and Effectiveness of 
EvroSure (Everolimus Drug Eluting CoCr Coronary Stent).
Name of Study: EverGreen
Protocol version: ECS/FM/030622.
We, the undersigned, have read and approved the protocol specified above, and agree to adhere 
to its requirements outlined within:
A. Investigator
Signature 
Date
B.
Sponsor Representative
Signature 
Date
Dr. Rony M Santoso
Primaya Tangerang Hospital, Indonesia Email: 
rony_msantoso@yahoo.com
08/12/2022

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TABLE OF CONTENTS 
PROTOCOL APPROVAL PAGE 
CONTACTS 
REGISTRY SUMMARY ...................................................................................................... 5 
1 INTRODUCTION .............................................................................................................. 7 
2 REGISTRY RATIONALE ............................................................................................... 9 
3 OBJECTIVES. ................................................................................................................... 10 
3.1 Primary objectives ........................................................................................................ 10 
3.2 Secondary objectives .................................................................................................... 10 
4 REGISTRY DESIGN ........................................................................................................ 10 
5 REGISTRY POPULATION ............................................................................................ 11 
5.1 Inclusion Criteria .........................................................................................................11 
5.2 Exclusion Criteria ....................................................................................................... 11 
5.3 Withdrawal, discontinuation and /or replacement of subjects .................................... 12 
6 REGISTRY TREATMENT .............................................................................................. 13 
6.1 Stents and delivery system ............................................................................................ 13 
6.2 Stent Placement ........................................................................................................... 13 
6.3 Criteria for good stent implantation… ......................................................................... 15 
6.4 End of Procedure .......................................................................................................... 15 
6.5 Medication .................................................................................................................... 15 
6.6 Instructions for return of damaged stents .................................................................... 15 
7 ENDPOINTS. ..................................................................................................................... 16 
7.1 Primary endpoints ........................................................................................................ 16 
7.2 Secondary endpoints .................................................................................................... 16 
8 REGISTRY PROCEDURES. ........................................................................................... 18 
8.1 Time and events schedule ............................................................................................ 18 
8.2 In/exclusion criteria ..................................................................................................... 19 
8.3 Medication .................................................................................................................... 19 
9 STATISTICAL DESIGN AND ANALYSIS. .................................................................... 20 
9.1 Power/size considerations ............................................................................................. 20 
9.2 Analytical plan ............................................................................................................. 20 
9.3 Subgroup analysis ........................................................................................................ 20 
9.4 Reporting ...................................................................................................................... 20 
10 ADVERSE EVENT REPORTING ................................................................................. 21 

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10.1 Definitions ................................................................................................................... 21 
10.2 Reporting of (Serious) Adverse Events ....................................................................... 23 
10.3 Follow-up of SAEs ...................................................................................................... 23 
11 ORGANIZATION ............................................................................................................ 24 
11.1 Sponsor ........................................................................................................................ 36 
12 QUALITY CONTROL AND QUALITY ASSURANCE ................................................ 25 
12.1 Investigator agreement ................................................................................................. 25 
12.2 Monitoring.................................................................................................................... 25 
12.3 Record retention ........................................................................................................... 26 
12.4 Publication policy .......................................................................................................... 26 
13 REFERENCES. .................................................................................................................. 27 
 
APPENDICES 
APPENDIX I – DEFINATIONS AND ACRONYMS… ............................................................... 29 

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REGISTRY SUMMARY 
 
OBJECTIVES 
The primary objective of this Registry is to assess the safety and effectiveness of EvroSure - 
Everolimus Drug Eluting CoCr Coronary Stent in obstructive coronary artery disease. 
INFORMED CONSENT FORM 
Before signing this consent document, I have made sure that I have discussed my participation in the 
EverGreen Registry, with my doctor and that all of my questions/doubts have been addressed. I 
confirm having received both oral and written explanations of the Registry to be conducted. The aim 
of the Registry is to assess the safety and effectiveness of the EvroSure – Everolimus Drug Eluting 
CoCr Coronary Stent in coronary arteries. The Registry will include follow visits at 1 month, 6 
months, and 12 months. The Primary Investigator has examined the project and given a favorable 
opinion. All documents belonging to my medical file are protected by professional secrecy and will 
remain strictly confidential. 
 
I have read discussed and understood the patient information and hereby consent to voluntarily 
participate in the EverGreen Registry. 
 
PATIENT ID:  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
DATE & TIME:  
 
 
 
 
SIGNATURE: 
 
 
PHYSICIAN NAME: 
 
 
 
 
 

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REGISTRY DESIGN 
This is a multi-Centre, prospective Registry. 888 (Or more) patients will be enrolled in the 
Registry. Patients will be followed up clinically for twelve months post-procedure at 1 month, 6 
months & 12 months. 
 
REGISTRY POPULATION 
The Registry population will consist of 888 (Or more) patients with an obstructive coronary artery 
disease with few exclusion criteria. They would therefore be representative of “Real- Life 
patients” and practice. 
 
TREATMENTS 
Patients will receive the Everolimus Drug eluting CoCr Coronary stents in sizes of 8, 12, 14, 18, 22, 26, 
 30, 34, 38-, 42-, 46-, 50 & 54-mm lengths, and diameters of 2.25, 2.5, 2.75, 3.0, 3.50, 4.0 and 4.50 mm. 
 
 
ENDPOINTS 
The primary safety endpoint of the Registry is defined as Major Adverse Cardiac Events (MACE) 
at 30 days. MACE rate is defined as the incidence of the combined clinical endpoint: Composite 
of Death (Cardiac death as well as Non-Cardiac), Myocardial Infarction (Q-wave and non-Q-
wave), Emergency Coronary Artery Bypass Graft Surgery, clinically justified TLR within 30 days 
following index procedure. 
The following secondary effectiveness endpoints will be as follows: 
• 
Angiographic/Device Success (%) (Initial in hospital) 
• 
Procedural Success (%)  
• 
Clinically justified Target Lesion Revascularization (TLR) (%) at 12 months 
 
The following secondary safety endpoints will be assessed: 
• 
MACE (%) until 12 months (Clinically Justified) 
• 
Device related SAEs until 12 months (Clinically Justified) 
 
 
 
Refer to Appendix I for definitions. 

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1.0 INTRODUCTION 
 
EvroSure stent is made up of unique hybrid cell design comprising of an intelligent mix of open 
and close cell designs resulting in a structure which provides excellent radial strength with a high 
degree of flexibility. 
It has been known from experiences of Simon et al and Kastrati et al (ISAR – STEREO 1 & 2) 
that thin strut stent results in lower incidence of restenosis as opposed to thicker strut stents. The 
hybrid design configuration contains an intelligent mix of close cells at the edges and open cells 
which are mid segment. The resultant scaffolding has a highly competitive radial strength of 1.1 
bars with the benefits of ultra-low strut thickness. 
During Biomechanical tests, EvroSure demonstrates extremely competitive (if not superior) 
properties as follows- 
• A metal to artery ratio ranging from 14% to 16% resulting in superior vessel wall coverage 
and thus ensuring better vessel wall coverage and uniform drug distribution. The 8 and 
10 crown configurations ensure that there are more cells per diameter, resulting in low 
recoil (<3%) and superior acute gain. 
• The unique design architecture ensures that foreshortening of the stent is < 0.29% (almost 
zero foreshortening). 
• EvroSure uses semi-compliant PTCA balloon catheter which has abrupt shoulders to 
eliminate balloon-related edge injury. The manufacturing process ensures that there is low 
balloon overhang thus adding to the low injury solution. 
• The catheter system is highly trackable and there is minimal loss in force transmission 
during navigation. Thus, reaching lesion sites through vessel tortuosity becomes easy with 
EvroSure 
• An interesting technology advantage that gets added to EvroSure is the high stent 
dislodgement force. This translates into extreme comfort during navigation in tortuous 
anatomical situations without the fear of stent dislodgement. 
Finally, since EvroSure is created on L605 cobalt chromium stent, the density of the alloy 
transmits sufficient radiopacity to the final stent. 
 

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Drug Everolimus 
 
EvroSure Everolimus Drug Eluting CoCr Coronary Stent has a drug loading of 1.10µ g/mm2 of 
stent surface area coated with Everolimus as the active anti-proliferative agent. An average 3.0 
mm x 22 mm of EvroSure would have 190µ g of Everolimus. The drug is timed to release from 
the biodegradable polymer surface in approximately 28 days after implantation. 
Mechanism of Action for Everolimus: 
Everolimus has dual mode of action. It modulates inflammatory cell function and blocks smooth 
muscle cell proliferation. Everolimus is cytostatic. It stops proliferation prior to G1 check point 
returning cells to the G0 resting phase. In this way, by not killing cells, it prevents vessel damage 
and allows rapid and complete re-endothelialization within 30 days. It thereby minimizes the 
potential for thrombosis. 
 
 
 
 
 
 
 
 
 
 

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It inhibits growth factor & cytokine stimulated cell proliferation. DNA damage check point (G1 
check):chk1-kinase inactivation before DNA replication and also inactivation of cdk2- cyclin a 
protein (growth factor). 
Polymer 
EvroSure uses a well-known and a well-documented co-polymer combination comprising of 
PLLA and PLGA which is biocompatible and biodegradable. The resultant polymer degrades in 
a period of 35- 45 days time and provides a uniformly thin coating of 1.5µm. 
The coating is highly stable to EtO process and does not web, crack or lump on stent/balloon 
surface. 
Safety and Device Biocompatibility 
The pre-clinical evaluation of EvroSure Everolimus Drug Eluting CoCr Coronary Stent was 
carried out as follows; an anti-proliferative activity test was performed in vitro and in-vivo. In 
vitro toxicity was performed by using the Indirect Agar Diffusion Method (ISO 10993-5). The 
suppressive activity of Everolimus against the Intimal Layer In-Vitro was tested. Leukocyte 
adhesion studies were performed. The device passed all the tests. 
 
Drug Biocompatibility and Safety 
The Everolimus Drug eluting CoCr Coronary stents are tested to assess the loading/content and 
release kinetics over 48-50 days. The stents are coated with polymers loaded with Everolimus, 
sterilized and had Everolimus load calculated gravimetrically (120 10 g) on 16-mm stents. 
Polymer coated stents were tested at 28 days in porcine coronary model and were found to be 
absent of fibrin, hemorrhage, necrosis, fibrinoid, or inflammation. 
Conclusions 
In short, the following conclusions can be stated: 
• 
Indigenously developed and designed EvroSure is a 
o predictably safe & efficacious 3rd generation DES, 
o with a propensity to minimize vascular injury by use of an intelligent mix of 
ultra-low strut thickness Co-Cr stent, 
o highly documented drug Everolimus & 
o a biocompatible, biodegradable polymer 

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2.0 REGISTRY RATIONALE 
This is a multi-center, prospective Registry aimed at evaluating the safety and effectiveness    
of the EvroSure - Everolimus Drug eluting CoCr Coronary stent in reducing neointimal 
hyperplasia and decreasing restenosis during PCI of stenotic coronary artery disease as well 
as intermediate term outcomes. The EvroSure- Everolimus Eluting Stent is a Drug Eluting 
Stent on a Cobalt Chromium platform with ultra-low strut thickness, High Radial Strength, 
Excellent conformability, Biodegradable polymer and Everolimus eluting characteristics. A 
stent of this type is expected to decrease restenosis following PCI and thereby improve the 
Clinical Outcomes. 
 
3.0 OBJECTIVES 
The main objective of this Registry is to assess the safety and effectiveness of the EvroSure 
Everolimus Drug eluting CoCr Coronary stent in obstructive coronary artery disease. 
 
 
3.1 Primary objectives 
The primary endpoint of the Registry is defined as Major Adverse Cardiac Events (MACE) at 
30 days. MACE rate is defined as the incidence of the combined clinical endpoint: Composite 
of Death (Cardiac death as well as Non-Cardiac), Myocardial Infarction (Q-wave and non-Q-
wave), Emergency Coronary Artery Bypass Graft Surgery, clinically justified TLR within 30 
days following index procedure. 
 
3.2 Secondary objectives 
 
The following secondary effectiveness endpoints will be as follows: 
• 
Angiographic/Device Success (%) (Initial in hospital) 
• 
Procedural Success (%) 
• 
Clinically justified Target Lesion Revascularization (TLR) (%) at 12 months 
 
The following secondary safety endpoints will be assessed: 
• 
MACE (%) until 12 months (Clinically Justified)  
• 
Device-related SAEs until 12 months (Clinically Justified) 
 
 
 
 

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4.0 REGISTRY DESIGN 
 
This is a multi-Centre, prospective Registry. 888 (Or more) patients will be enrolled in the 
Registry. Patients will be followed up clinically for twelve months post-procedure at 1 month, 
6 months & 12 months. 

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Approximately 888 patients with obstructive coronary artery disease with a vessel size between 2.5 to 
4.50 mm in diameter by visual estimate and who meet all eligibility criteria will be treated with the 
Everolimus Drug Eluting CoCr Coronary Stent. 
 
  Total 888 patients will be enrolled. 
It is anticipated that the total length of the Registry will be 24 months. 
5.0 REGISTRY POPULATION 
 
Total 888 patients eligible for coronary stenting and who meet the following entry criteria will be enrolled. 
The Registry population will consist of 888 (Or more) patients with an obstructive coronary artery 
disease with few exclusion criteria. They would therefore be representative of “Real- Life 
patients” and practice. 
 
5.1 Inclusion criteria 
Patients must meet ALL of the following criteria: 
1. 
The patient must be ≥ 18 years of age; 
2. 
Patient was an acceptable candidate for PTCA, Stenting, or Emergent CABG; 
3. 
 Patient has clinical evidence of ischemic heart disease or a positive functional study 
4. 
Patient and his or her treating physician agree that the patient will comply with all the required post-procedure
follow-up.   
5. 
Target lesion(s) present with ≥50% stenosis, in one or more vessels 
6. 
Target lesions has to be de novo; 
7. 
One or more target lesions require treatment 
8. 
Reference vessel diameter of target lesion(s) must be ≥ 2.25mm and ≤ 4.5mm, by visual estimate. 
 
 
5.2 Exclusion criteria 
Patients will be excluded if ANY of the following conditions apply: 
 
 
General exclusion criteria: 
1. 
Previous PTCA with any stent 
2. 
History of CVA or TIA within the last 3 months 
3. 
Patient has active infection 
4. 
Concurrent medical condition with a life expectancy of less than 12 months 
5. 
Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate, or ticlopidine including 
thrombocytopenia, neutropenia, or leukopenia 

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6. 
 Active peptic ulcer or upper gastrointestinal bleeding 
7. 
Current participation in an investigational drug or device trial that has not completed its primary 
endpoint follow-up period 
8. 
Pregnancy or woman of childbearing potential who, in the opinion of the investigator, does not take 
adequate measures to prevent conception 
9. 
 Known hypersensitivity or contraindication to cobalt, chromium, or nickel 
 
Angiographic Exclusion criteria 
1. 
Angiographic evidence of thrombus (thrombus larger than half the diameter of the 
vessel and/or requiring other adjunctive interventions such as Angiojet, Exciser, 
Thrombolysis, etc.), 
2. 
Saphenous Vein Graft Interventions, (S.V. G’s) 
 
3. 
Patients having undergone a PCI within 48 hours of an AMI episode. 
5.3 
Withdrawal, discontinuation, and/or replacement of subjects 
All patients have the right to withdraw at any point during the period of the clinical Registry.   
It will be documented whether or not each patient completed the clinical Registry. 
Every attempt should be made to collect follow-up information. Discontinued patients will not 
be replaced. 
6.0 REGISTRY TREATMENT 
 
6.1 Stents and delivery system 
 
STENT: 
The Everolimus Drug Eluting CoCr Coronary Stent is indicated for use in-patients with 
symptomatic ischemic heart disease due to obstructive coronary artery disease with a reference 
vessel diameter ranging from 2.25 mm to 4.50 mm and is intended to improve coronary luminal 
diameter. 
 
Available Registry Stent Sizes 
 
Diameters 
(mm) 
Available Lengths (mm) 
2.25 
8 
12 
14 
18 
22 
26 
30 
34 
38 
42 
46 
50 
54 
2.50 
8 
12 
14 
18 
22 
26 
30 
34 
38 
42 
46 
50 
54 
2.75 
8 
12 
16 
20 
24 
28 
32 
36 
40 
42 
46 
50 
54 

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3.00 
8 
12 
16 
20 
24 
28 
32 
36 
40 
42 
46 
50 
54 
3.50 
8 
12 
16 
20 
24 
28 
32 
36 
40 
42 
46 
50 
54 
4.00 
8 
12 
16 
20 
24 
28 
32 
36 
40 
42 
46 
50 
54 
4.50 
8 
12 
16 
20 
24 
28 
32 
36 
40 
42 
46 
50 
54 
 
Balloon 
 
Balloon is made up of nylon material having PTFE coated stainless steel hypo tube shaft. Two 
radiopaque markers located underneath the balloon, fluoroscopically mark the working length of 
the balloon. 
 
6.2 Stent placement 
Using the Instructions for Use, the investigator should determine the appropriate diameter of the 
Everolimus Drug Eluting CoCr Coronary Stent to be implanted. 
 
Preparation and percutaneous access should be performed according to standard hospital 
procedures. After percutaneous access is obtained, Heparin should be administered in accordance 
with the standard institutional procedures. 
 
The target lesion should be crossed with a 0.014” exchange-length guide wire and predilated with 
an appropriately sized balloon. Balloon predilatation of the target lesion must be performed 
according to standard operational techniques. Investigators should use similar materials and 
techniques throughout the Registry to maintain consistency and standardisation of care. 
The goal of stent implantation is to achieve an angiographic appearance of the stent expanded 
just outside the boundaries of the vessel filled with contrast medium. 
To select the proper stent/balloon size, the investigator should: 
1. 
Measure the reference vessel diameter; 
2. 
Calculate the balloon size using compliance curves in the Instructions for Use to achieve 
stent/vessel ratio of 1.1:1, prior to stent placement; 
3. 
Select the stent system that, at nominal pressure, provides this ratio. 
Example: A stent/vessel ratio of 1.1:1 for a reference vessel of 3.2 mm mean diameter 
implies the use of a balloon/stent system of 3.5mm (3.2mm x 1.1 = 3.5mm) using the 
nominal pressure as recommended. 
4. 
Select the length of the stent such that lesion stent ratio is of at least 1: 1.1. 
 

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The delivery system is introduced over the exchange wire and advanced until the markers 
identifying the ends of the balloon catheter bracket the target lesion. The appropriate position of 
the stent is reconfirmed by contrast injection. The stent delivery balloon is then progressively 
inflated to the maximum recommended pressure as indicated in the Instructions for Use. 
 
If stent/vessel ratio of 1.1:1 is not achieved, the stent may be re-crossed with an appropriate-sized 
balloon. Should resistance be experienced, withdraw the balloon catheter under fluoroscopic 
guidance. Center the balloon within the stent and re-dilate the stent to achieve the optimal result. 
Refer to the Instructions for Use for clarification, if necessary. 
 
Following balloon deflation and withdrawal repeat angiography must be performed. Further stent 
expansion using a larger balloon at higher pressures may be used to achieve optimal sizing. Post-
procedure, repeat angiograms must be taken from the original pre-procedural views after 
withdrawal of the guidewire(s) and after intracoronary injection of nitrates. 

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In the event of a failure to implant the stent (EvroSure) by using the required implantation method, 
the Investigator may choose to treat the target lesion with another approved device of his choice. 
This device will be appropriately recorded if it is not the Registry device 
If a dissection occurs during predilatation or stent implantation an additional Registry stent should 
be used identical to the Registry treatment. This will not be considered as a “Protocol 
Deviation”. 
 
6.3 Criteria for good stent implantation 
The investigator should strive for optimal result, using on-line QCA, if available. The following 
definitions will be used to describe treatment outcome: 
Optimal stent result is obtained when both of the following criteria are applicable: 
1. Diameter stenosis within the stent  20% by QCA 
2. Mean reference diameter of the stent >1.1 with respect to the reference diameter of the 
adjacent segments. 
 
6.4 End of procedure 
The procedure ends when the guiding catheter has been removed and the patient is off the table. 
If thereafter the guiding catheter is reinserted and a dilatation is performed, this should be 
considered a repeat intervention and has to be recorded on the CRF. 
 
6.5 Medication 
Pre- and post-procedure medications to be given according to AHA guidelines and dual 
antiplatelet for post-procedure according to AHA guidelines 
 
6.6 Instructions for return of damaged stents 
The damaged stents should be returned to the local distributor. 
 
Damaged stents: 
Stents may get damaged because of improper handling before angioplasty. 
Before opening, carefully stent delivery system package should be inspected, sterile barrier should 
be checked for any damages. Prior to using the device, the system should be carefully removed 
from the package and it should be inspected for bends, kinks, and other damage. Do not use the 
device if any damage to the packaging is noted. 

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In case of such damages, the stents are returned back to the factory where stringent inspection 
is done of the stent and root cause analysis is done. 
If it is a case of improper handling at the Cath-lab site then proper instructions are given to the 
Cath-lab operator to avoid such incidents. 
We perform 100% quality check i.e. on each and every stent & records of identification, 
traceability, and retrievability are maintained for each & every stent at production site. 
 
Damage of Outer Box (Secondary Packing): 
Stents are returned back to the factory if the outer box is damaged. The inner pouch is observed 
as per the in-house developed quality guideline such as any kind of damage to or indication of 
damage (integrity of seal, mechanical damage, etc.) to the primary packing and if it is found 
undamaged then they are packed in a new outer box. 
 
Damage of Primary Packing: 
If the inner pouch is also damaged or any indication of damage is observed, it is strongly 
recommended that the stent must not be used. And since drug coated stents are not subjected for 
re-sterilization, these stents are not used for their intended purpose. 
 
7.0 ENDPOINTS 
 
7.1 
Primary endpoints 
The primary endpoint of the Registry is defined as Major Adverse Cardiac Events (MACE) at 30 
days. MACE rate is defined as the incidence of the combined clinical endpoint: Composite of 
Death (Cardiac death as well as Non-Cardiac), Myocardial Infarction (Q-wave and non-Q-wave), 
Emergency Coronary Artery Bypass Graft Surgery, clinically justified TLR within 30 days 
following index procedure. 
 
7.2 
Secondary endpoints 
The following secondary effectiveness endpoints will be as follows: 
• 
Angiographic/Device Success (%) (Initial in hospital) 
• 
Procedural Success (%) 
• 
Clinically justified Target Lesion Revascularization (TLR) (%) at 12 months 
 
The following secondary safety endpoints will be assessed: 
• 
MACE (%) until 12 months (Clinically Justified) 

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• 
Device related SAEs until 12 months (Clinically Justified)  
 
1. A history of recurrent angina pectoris presumably related to the target vessel. 
2. Objective signs of ischemia at rest (ECG changes) or during exercise test (or its equivalent) 
presumably related to the target vessel. 
3. Abnormal results of any invasive functional diagnostic test (e.g. Doppler flow velocity 
reserve, fractional flow reserve). 

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8.0 REGISTRY PROCEDURES 
 
8.1 Time and events schedule 
All patients are asked to visit the clinic at 1 month (time window plus or minus 7 days), 6 month 
(time window plus or minus 15 days) and 12 months (time window plus or minus 30 days) after 
the procedure. OR they will be followed up by telephone OR by email at 1 month, 6 month, and 
12 months.  All efforts should be made to complete the required observations as much as possible. 
If the patient cannot be seen at the visit at 12 months, it is obligated to obtain information 
concerning possible events by a phone call to the patient or his general practitioner or family. A 
further extended clinical follow-up will be maintained for all patients at 36 and 60 months via 
phone call or a personal visit to the clinic if possible. 
Figure 1: Investigations and measurements are carried out according to the following 
Schedule 
In- Hospital 
Event 
Screening 
Pre 
Post 
1 Month 
6 
Months 
12 Months 
Inclusion/Exclusion 
Criteria 
X 
Physical Examination 
X 
Medical History 
X 
Anginal Status 
X 
X 
X 
X 
X 
Laboratory 
X 
X 
X 
X 
X 
CK/CK-MB/Troponin 
(optional) 
X 
X 
X 
X 
X 
Medication Regimen 
X 
X 
X 
X 
X 
Adverse Event 
Monitoring 
X 
X 
X 
X 
Angiography 
X 
X 
Out of Clinic FUP 
X 
X 
X 

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(Telephone, Mail, 
Others) 
 
• It is recommended that patients come back for a physician office visit at 1, 6-, 12-months 
post-procedure, but data could also be collected by telephone, mail or the referring 
cardiologist (including ECG) should a physician office visit not be possible. 
• 1 Month follow-up Time Window + 7 days 
• 6 Months follow-up Time Window + 15 days 
• 12 Months follow-up Time Window + 30 days 
 
8.2 In/exclusion criteria 
All general and medical inclusion and exclusion criteria will be screened before the patient enrolls 
in the registry. A qualifying Angiogram will be used to assess Inclusion and Exclusion criteria 
related to angiography. 
 
8.3 Medication 
Cardiac medications taken will be recorded at screening, at hospital discharge, and at all planned 
follow-up visits. 
 
 
9.0 STATISTICAL DESIGN AND ANALYSIS 
 
9.1 Power/size considerations 
 
This is an observational, prospective, Registry. A total of 888 patients will be enrolled. 
 
9.2 Analytical plan 
The primary analysis will be performed according to the intention to treat principle. 
Descriptive statistics will be performed for all relevant variables. Count variables will be 
summarised by the count and the percentage. Continuous various variables will be summarised 
by the mean, standard deviation, minimum and maximum. The event variables, such as MACE, 
will also be summarized as time-to-event variables and presented using the Kaplan-Meier method. 
The MACE per patient will be ranked according to the highest category on a scale ranging from 
(1) death, (2) MI, (3) CABG to (4) TLR. 
 
 
9.3 Subgroup analysis 

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No subgroup analyses are planned. 
 
9.4 Reporting 
The primary analysis will be performed once the one-month follow-up of all the patient’s results 
has been obtained. A final clinical report will be provided at the end of the registry. 
 
10.0 ADVERSE EVENTS REPORTING 
 
10.1 Definitions 
At each evaluation, the investigator will determine whether any adverse events (AEs) have 
occurred. For the purpose of this protocol, an adverse event is any undesirable clinical occurrence 
in a subject that can be attributed to the device, EvroSure Everolimus Drug Eluting CoCr 
Coronary Stent, procedure or medications required by this protocol (i.e., Aspirin, Clopidogrel 
Bisulfate [Plavix®], or other antiplatelet medication). The following Anticipated Events have 
been identified as possible complications of stent implantation: 
Anticipated Events 
1 
Abrupt stent closure 
 
2 
Allergic/immunologic reaction to anti-coagulant 
and/or antithrombotic therapy agents or contrast 
medium 
3 
Aneurysm 
4 
Arrhytmia’s 
(bradycardia, 
rhythmical 
disturbances) 
5 
Arterial perforation 
6 
Bleeding complications 
7 
Cardiac tamponade 
8 
Cardiogenic shock 
9 
Death 
10 Dissection 
11 Drug reactions to antiplatelet agents/ 
anticoagulation agents/contrast medium 
12 Emboli (tissue, air or thrombi emboli)  
13 Embolization 
14 Emergency CABG 
15 Entry site complications 
16 Fever 
17 Fistulization 
18 Heart Failure 
19 Hemorrhage (hematoma) 
20 Hypotension/hypertension 
21 Infection (and pain at insertion site) 
22 Myocardial infarction 
23 Myocardial ischemia 
24 Nausea and vomiting 
25 Occlusion 
26 Palpitations 
27 Perforation or rupture 
28 Pericardial effusion   
29 Prolonged angina 
30 Pseudoaneurysm 
31 Renal failure 
32 Respiratory Failure 
33 Restenosis of the stented segment 
34 Rupture of native coronary artery 
35 Shock/pulmonary oedema 
36 Stent compression 
37 Stent dislodgment 
38 Stent migration 
39 Stroke 
40 Thrombosis (acute, subacute or late) 
41 Unstable Angina Pectoris 
42 Vascular complications, which may require 

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vessel repair  
43 Ventricular fibrillation 
44 Vessel spasm 

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The following Anticipated Events have been identified as possible complications of 
Everolimus coating: 
Sl. No 
Anticipated Events 
1.  
Allergic/immunologic reaction to drug or stent coating 
2.  
Alopecia 
3.  
Anemia 
4.  
Blood product transfusion 
5.  
Gastrointestinal symptoms 
6.  
Hematologic dyscrasia (including leukopenia, neutropenia, thrombocytopenia) 
7.  
Hepatic enzyme changes 
8.  
Histologic changes in vessel wall, including inflammation, cellular damage, or necrosis 
9.  
Myalgia/Arthralgia 
10.  
Peripheral neuropathy 

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The following Anticipated Events have been identified as possible complications of the medicine 
Everolimus: 
Anticipated Events 
1. Change in taste 
2. Mouth blistering 
3. Change in color of the nails 
4. Nausea and vomiting 
5. Change in normal bowel habits for more than 
2 days 
6. Pain in the joints of the arms or legs lasting 2-3 
days 
7. Chest pain 
8. Pain redness, or swelling at the injection site 
9. Chills 
10. Severe exhaustion 
11. Cough 
12. Shortness of breath 
13. Difficulty swallowing 
14. Skin rash 
15. Dizziness 
16. Sore throat 
17. Facial flushing 
18. Tingling in the hands or toes 
19. Fatigue 
20. Thinned or brittle hair 
21. Fever 
22. Unusual bruising or bleeding 
23. Loss of appetite 
 
 
Unanticipated Adverse Device Effects (ADEs) are defined as adverse effects on health or safety 
or any life-threatening problem or death caused by or associated with a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or IDE application, or any other unanticipated serious problem associated 
with a device that relates to the rights, safety, or welfare of patients. 
 
Adverse Event (AE): An adverse event is defined as any undesirable clinical event occurring to 
a subject, during a clinical Registry, whether or not considered related to the investigational 
product(s). 
 
Serious Adverse Event (SAE): an adverse event is defined as serious, whenever the adverse 
event results in the patient’s death, is life-threatening, results in permanent or remarkable 
disability/dysfunction, requires in-patient hospitalization or prolongation of hospitalization, 
results in fetal death or distress, is a congenital anomaly/birth defect and in cases of 
cancer/malignancy or required surgical or medical intervention to prevent permanent impairment. 
 
10.0 Reporting of (Serious) Adverse Events 
All AEs and SAEs since randomization must be recorded in the CRF and source documents.  

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All SAEs or unanticipated adverse device effects (ADE) must be reported to Frisch Medical 
immediately (within 24 hours) by email 
 
10.1 Follow-up of SAEs 
All adverse events occurring during the Registry are to be followed up in accordance with good 
clinical practice until resolved or judged no longer clinically significant, or in case of a chronic 
condition until fully characterized. All follow-up results are to be reported to Frisch Medical 
Devices Pvt. Ltd. 

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11.0 ORGANIZATON 
 
11.1 Sponsor 
 
Sponsor: 
Frisch Medical Devices Pvt. Ltd. 
89, ACHHAD INDUSTRIAL AREA, ACHHAD, TA- 
TALASARI, Palghar, Maharashtra (India)- 401606 
 
11.2 Investigator:  
     
 
 

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12.0 QUALITY CONTROL AND QUALITY ASSURANCE 
 
12.1 Investigator Agreement 
The Investigator agrees to conduct the clinical Registry in compliance with the protocol agreed 
to by the sponsor. The Investigator and the sponsor should sign the protocol to confirm this 
agreement. 
The investigator agrees not to deviate from or make changes to the protocol without prior 
knowledge and approval of the sponsor except where necessary to eliminate an immediate hazard 
to clinical Registry patients. In this event, the Sponsor should be notified as soon as possible. The 
Investigator should document and explain any deviation or change from the approved protocol. 
The Investigator agrees to allow monitoring and auditing of all essential clinical Registry 
documents by the Frisch Medical and inspection by the appropriate regulatory authorities. 
Monitoring and auditing visits by Frisch Medical should be scheduled at mutually agreeable times 
periodically throughout the Registry. 
 
12.2 Monitoring 
Trained and qualified personnel from the Sponsor will monitor the Registry throughout its 
duration by means of One personal visit to the Investigator’s facilities and by other 
communication.  
- 
the progress of the Registry, 
- 
verify whether the reported clinical Registry data are accurate, complete, and verifiable 
from source documents, 
- 
Whether the protocol and applicable amendments are being followed. 
 
 

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12.3 Record retention 
The investigator should maintain the essential clinical Registry documents (including CRFs, 
source documents, device disposition records, adverse event reports, and other regulatory 
documents) as required by the applicable regulatory requirements. The investigator should take 
adequate measures to prevent accidental or premature destruction of these documents. 
Essential clinical Registry documents should be retained for a minimum of two years after the 
last approval of the marketing application, or at least two years after formal discontinuation of 
clinical development of the investigational product. These documents should be retained for a 
longer period, however, if required by the applicable regulatory requirements or by an agreement 
with the Sponsor. 
If the investigator retires, relocates, or for other reasons withdraws from the responsibility of 
keeping the Registry records, custody must be transferred to a person who will accept 
responsibility. 
 
12.4 Publication policy 
The Sponsor and Investigators are committed to the publication and widespread dissemination of 
the results of the Registry. This Registry represents a joint effort between the Sponsor and 
Investigators, and as such, the parties agree that the recommendation of any party concerning 
manuscripts or text shall be taken into consideration in the preparation of final scientific 
documents for publication or presentation. All proposed publications and presentations by 
Sponsor and Investigators or their personnel and associates resulting from or relating to the 
Registry must be submitted to the Steering Committee for review and approval prior to 
submission for publication or presentation. 
If any such proposed publication or presentation contains patentable subject matter which in 
Sponsor's sole discretion, warrants intellectual proprietary protection, Sponsor may delay any 
publication or presentation for up to thirty (30) days after Steering Committee approval for the 
purpose of pursuing such protection. 

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13.0 
REFERENCES 
 
1. 
Sousa JE, Costa MA, Abizaid A, et al. Lack of Neo-intimal Proliferation After 
Implantation of Everolimus-Coated Stents in Human Coronary Arteries :  A Quantitative 
Coronary Angiography and Three-Dimensional Intravascular Ultrasound Registry. 
Circulation 2001; 103:192-195. 
2. 
Sousa JE, Costa MA, Abizaid AC et al. Sustained Suppression of Neo-intimal 
Proliferation by Everolimus-Eluting Stents: One-Year Angiographic and Intravascular 
Ultrasound Follow-Up. Circulation 2001; 104:2007-2011. 
3. 
Rensing B, Vos J, Smits P et al. Coronary restenosis elimination with a Everolimus eluting 
stent. First European human experience with six month angiographic and intravascular 
ultrasonic follow-up. Eur Heart J. 2001; 22: 2125-2130. 
4. 
De Jaegere P, Mudra H, Figulla H et al. Intravascular ultrasound-guided optimized stent 
deployment. Immediate and 6 months clinical and angiographic results from the 
Multicenter Ultrasound Stenting in Coronaries Registry (MUSIC  Registry). Eur Heart J. 
1998;19: 1214-23. 
5. 
Albiero R, Nishida T, Adamian M et al. Edge restenosis after implantation of high 
activity (32) P radioactive beta-emitting stents. Circulation 2000; 101: 2454-7. 
6. 
Wardeh AJ, Knook AH, Kay IP et al. Clinical and angiographical follow-up after 
implantation of a 6-12 micro. Ci radioactive stent in patients with coronary artery disease. 
Eur Heart J. 2001; 22: 669-675. 
7. 
Meerkin D, Tardif JC, Crocker IR, et al. Effects of intracoronary beta-radiation therapy 
after coronary angioplasty: an intravascular ultrasound Registry. Circulation 1999; 99: 
1660-5. 
8. 
Kay IP, Sabate M, Van Langenhove G et al. Outcome from balloon induced coronary 
artery dissection after intracoronary beta radiation. Heart 2000; 83: 332-7. 
9. 
Kay IP, Sabate M, Costa MA et al. Positive Geometric Vascular Remodeling Is Seen 
After Catheter-Based Radiation Followed by Conventional Stent Implantation but Not 
After Radioactive Stent Implantation. Circulation 2000; 102: 1434-1439. 
10. 
Sabate M, Serruys PW, van der Giessen WJ et al. Geometric vascular remodeling after 
balloon angioplasty and beta- radiation therapy: A three-dimensional intravascular 
ultrasound Registry. Circulation 1999; 100: 1182-8. 

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11. 
Kozuma K, Costa MA, Sabate M et al. Late Stent Malapposition Occurring After 
Intracoronary Beta-Irradiation Detected by Intravascular Ultrasound. J Invasive 
Cardiol.1999; 11: 651-655. 
12. 
Waksman R, Bhargava B, Leon MB. Late thrombosis following intracoronary 
brachytherapy. Catheter Cardiovasc Interv. 2000; 49: 344-7. 
13. 
Castagna MT, Mintz GS, Weissman N, Maehara A, Finet G, Waksman R. "Black hole": 
echolucent restenotic tissue after brachytherapy. Circulation 2001; 103: 778. 
14. 
Kay IP, Wardeh AJ, Kozuma K et al. The pattern of restenosis and vascular remodelling 
after cold-end radioactive stent implantation. Eur Heart J. 2001; 22: 1311-7. 
15. 
Morice MC, Serruys PW, Sousa JE et al. Revascularization with a Everolimus eluting 
versus an uncoated stent in patients with coronary artery disease. The RAVEL Registry. 
N Eng J Med. In press. 
16. 
Rowinsky E K, Donehower R C. Everolimus (taxol). N Engl. J Med. 1995; 332:1004- 
1014. 
17. 
Axel D I, Kunert W, Goggelmann C, et al. Paclitaxel inhibits arterial smooth muscle  cell 
proliferation and migration in vitro and in vivo using local drug delivery. Circulation 
1994; 96:636-645. 
18. 
Sollott SJ, Cheng L, Pauly RR, et al. Taxol inhibits neointimal smooth muscle cell 
accumulation after angioplasty in the rat. J Clin Invest. 1995; 95:1869-1876. 
19. 
Heldman AW, Cheng L, Heller P, et al. Paclitaxel applied directly to stents inhibits 
neointimal growth without thrombotic complications in a porcine coronary artery model 
of restenosis. Circulation 1997; 96: I-288. 
20. 
 Kornowski R, Hong MK, Ragheb AO, Bramwell O, Leon MB. Slow Release paclitaxel 
coated GRII stents reduce neointimal formation in a porcine coronary in-stent restenosis 
model. Circulation 1997; 96: I-341. 
21. 
 Frab A, Heller PF, Carter AJ, et al. Paclitaxel  polymer-coated  stents  reduce  neointima. 
Circulation 1997; 96: I-608. 
22. 
Wilensky RL, March KL, Gradus-Pizlo I, Speady AJ, Hathaway DR. Methods and devices 
for local drug delivery in coronary and peripheral arteries. Trends Cardiovasc Med. 1993; 
3:163-170 
 
 
 
 
 

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APPENDIX I - DEFINITIONS AND ACRONYMS 
Acute gain  
 
post-procedure minimal lumen diameter (MLD) minus the pre-procedure MLD measured 
by Quantitative Coronary Angiography (QCA). 
 
ADE (Adverse Device 
Effect) 
 
Adverse effects on health or safety or any life-threatening problem or death caused by or 
associated with a device, if that effect, problem, or death was not previously identified in 
nature, severity or degree of incidence in the investigational plan or IDE application, or any 
other unanticipated serious problem associated with a device that relates to the rights, safety, 
or welfare of patients. 
 
AE (Adverse Event)  
 
Any undesirable clinical event occurring to a subject, during a clinical Registry, whether or 
not considered related to the investigational product(s). 
 
Angiographic Stent 
Thrombosis/Occlusion 
 
Angiographic stent thrombosis is defined as the angiographic documentation of either a 
complete occlusion (TIMI flow 0 or 1) or an angiographic documentation of a flow limiting 
thrombus (TIMI flow 1or 2). A Subacute Occlusion is defined as occurring after removal 
of the guiding catheter, before 30 days follow-up. 
 
Angiographic success  
 
Percentage of patients with a successful delivery and deployment of the Registry stent to 
the target lesion without use of a device outside the Registry treatment strategy and a final 
diameter stenosis after stenting £20% in the presence of grade 3 TIMI flow. 
 
ASA  
 
Acetylsalicylic acid: Chemical name for aspirin; a drug having antiplatelet, anti-
inflammatory, analgesic, and antipyretic effects. 
 
Bleeding 
complications 
 
Bleeding will be considered major if: 
1. it leads to death; 
2. it leads to permanent disability; 
3. it is clinically suspected or proven to be intracranial (see stroke) 
4. it produces a fall in hemoglobin of at least 3 mmol/l; 
5. it leads to transfusion of 2 or more units of whole blood of packed cells; 
6. Peripheral vascular surgery is necessary. 
All other bleeding will be considered as minor. 
 
Braunwald 
classification of 
unstable angina  
 
Severity  
Class 1: New onset of severe or accelerated angina. Patients with new onset (<2 months in 
duration) 
exertional angina pectoris that is severe or frequent (<3 episodes/day) or patients with 
chronic stable angina who develop accelerated angina (that is, angina distinctly more 
frequent, severe, longer in duration, or precipitated by distinctly less exertion than 
previously) but who have not experienced pain at rest during the preceding 2 months. 
Class 2: Angina at rest, subacute. Patients with one or more episodes of angina at rest 
during the preceding 
month but not within the preceding 48 hours. 
Class 3: Angina at rest, acute. Pts with one or more episodes of angina at rest within the 

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preceding 48 hours. 
Clinical circumstances in which unstable angina occurs: 
Class A: Secondary unstable angina. Patients in whom unstable angina develops secondary 
to a clearly 
identified condition extrinsic to the coronary vascular bed that has intensified myocardial 
ischemia. Such conditions reduce myocardial oxygen supply or increase myocardial oxygen 
demand and include anemia, fever, infection, hypotension, uncontrolled hypertension, 
tachyarrhythmia, unusual emotional stress, 
thyrotoxicosis, and hypoxemia secondary to respiratory failure. 
Class B: Primary unstable angina. Patients who develop unstable angina pectoris in the 
absence of an extra 
cardiac condition that have intensified ischemia, as in class A. 
Class C: Post infarction unstable angina. Patients who develop unstable angina within the 
first 2 weeks after a documented acute myocardial infarction 
 
CABG 
Coronary Artery Bypass Graft. 
CCS (Canadian 
Cardiovascular 
Society) classification 
 
Class I: Ordinary physical activity, such as walking and climbing stairs, does not cause 
angina. Angina with strenuous, rapid, or prolonged exertion at work or recreation. 
Class II: Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking 
up hill, walking or stair climbing after meals, in cold, in wind, or when under emotional 
stress or during the first few hours 
after awakening may cause pain. Walking more than two blocks on the level and climbing 
more than one flight of stairs at a normal pace and in normal conditions. 
Class III: Marked limitation of ordinary physical activity. Walking one-two blocks on a 
level and climbing one flight of stairs at normal pace results in angina. 
Class IV: Inability to carry on any physical activity without discomfort. Anginal 
syndrome may be present at rest. 
 
Clinical Stent 
thrombosis 
Composite 30 days ischemic endpoint including cardiac death, Q-wave MI or sub abrupt 
closure requiring revascularization. Stent thrombosis is defined as angiographic thrombus 
within the stented vessel at the time of the clinically driven angiographic restudy for 
documented ischemia (chest pain and ECG changes), representing abrupt or sub abrupt 
closure. Only angiographic stent thrombosis requiring target lesion revascularization during 
the first 30 days after stent placement was considered as an endpoint for the combined 30-
days ischemic endpoint. 
De novo lesion 
A coronary lesion not previously treated. 
 
Dissection NHLBI 
classification National 
Heart Lung and Blood 
Institute: 
 
A – Intraluminal radiolucent defect 
B – Extraluminal “cap” (without staining) 
C – Extraluminal “cap” with persistence of dye (staining) 
D – Spiral defects 
E – Persistent filling defect 
F – Filling defect with total occlusion 
Note: Types E & F dissections may be caused by thrombus 
 

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DS (Diameter 
Stenosis) 
Percent DS – Value calculated as 100 * (1 –(MLD/RVD). A 100 %DS is imputed for total 
occlusions. 
 
Late loss 
Late lumen loss is defined as the difference in minimal lumen diameter (MLD) between 
post-procedural and follow-up in mm 
 
MACE (Major 
Adverse Cardiac 
Events) 
 
Composite of Death (Both Cardiac & Non-Cardiac Death), MI (Q-wave and Non Q-wave), 
(emergent) 
CABG or clinically driven Target Lesion Revascularization (TLR). 
 
Major vascular 
complications 
All pseudoaneurysms, vascular access site bleeding associated with a decrease in 
hemoglobin ³3.0 mmol/L as well as vascular events which required surgical repair or 
transfusion of > 2 units within 30 days of the procedure. 
 
MI (Myocardial 
Infarction) 
Necrosis of the myocardium, as a result of interruption of the blood supply to the area, as 
in coronary thrombosis. 
 
MI, non-Q-Wave 
Elevation of post-procedure CK levels to >2 times normal with elevated CK-MB in the 
absence of pathological Q waves. If no assay for CK-MB was performed, elevation of 
CK levels to >2 times normal without new Q waves is also considered a non-Q-wave 
MI. 
 
MI, Q-Wave  
MI, Q-Wave Development of new, pathological Q waves in 2 or more contiguous leads 
(as assessed by the investigator and confirmed by the Clinical Endpoint Committee) with 
post-procedure CK-MB levels elevated above normal. 
 
MLD (Minimal 
Lumen Diameter)  
MLD (Minimal Lumen Diameter) Mean Minimal Lumen Diameter (mm). 
Optimal stent results 
1. Diameter stenosis within the stent £20%. 
2. Ratio of reference diameter of the stent to the to the reference diameter of the vessel 
segments proximal and distal to the stented segment > 1.1 
 
Percent in-stent 
volume obstruction 
 (Stent volume – lumen volume/stent volume) *100 
 
Procedural success 
the stents were deployed successfully without any adverse events or serious adverse 
events occurring. 
 
Procedure success 
rate 
Percentage of patients with angiographic success and without the occurrence of MACE 
during the index hospitalization. 
 
QCA (Quantitative 
Coronary 
Angiography, off-line) 
Off-line refers to assessment at the Angiographic Core Laboratory. The method is a 
quantitative estimate obtained with a digital angiographic computer utilizing an 
automatic edge detection algorithm. 
 
RVD (Reference 
Interpolated reference diameter 

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Vessel Diameter) 
 
SAE (Serious Adverse 
Event) 
An adverse event is defined as serious, whenever the adverse event is fatal, life-
threatening, results in persistent or significant disability/incapacity, requires inpatient 
hospitaliztion or prolongation of hospitalization, results in fetal death or distress, is a 
congenital anomaly/birth defect and in cases of cancer/malignancy. 
 
Stroke 
A focal neurological deficit, resulting from a vascular cause involving the CNS, of sudden 
onset that is not reversible within 24 hours (including death) and which is not due to a 
readily identifiable cause (i.e. brain tumor, trauma). 
 
TLR (Target Lesion 
Revascularization) 
Any repeat treatment of the stented segment including 5 mm proximal and 5 mm distal 
from the edge of the stent. 
 
TVF (Target Vessel 
Failure) 
Cardiac Death, MI (Q-wave and non-Q-wave) or Target Vessel Revascularization (TVR) 
that could not be clearly attributed to a vessel other than the target vessel. 
 
TVR (Target Vessel 
Revascularization) 
 
Revascularization of any segment of the index coronary artery, which was in physical 
contact with any component (guiding catheter, guidewire, balloon catheter, etc.) of the 
angioplasty hardware during the initial procedure 
 
TWS (Technician’s 
Work Sheet) 
Part of the CRF used to specify the details of the angiographic procedure and the 
angiographic observations