MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon
Phase: PHASE4
Conditions: Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
Sponsor: Frisch Medical Device Private Limited

Protocol version: ESC/FM/030603
    Property of Frisch Medical     
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A Prospective Multi-Centre  
Clinical Investigation of the 
Mamba 
(Sirolimus Drug Eluting PTCA 
Balloon) 
to Investigate Safety and 
Effectiveness 
Name of Study: MIRAGE
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.” 
Document no :  ECS/FM/030603                                                                           Date:  01st February 2023

Protocol version: ESC/FM/030603
    Property of Frisch Medical     
   Page 2 of 16 
Contents 
PROTOCOL APPROVAL PAGE ........................................................................................................................... 3 
PROTOCOL SUMMARY ..................................................................................................................................... 4 
Study Objectives: ......................................................................................................................................... 4 
Endpoints: .................................................................................................................................................... 4 
Study Population: ......................................................................................................................................... 4 
Inclusion/Exclusion criteria: ......................................................................................................................... 4 
Study Design: ............................................................................................................................................... 5 
Introduction ................................................................................................................................................. 5 
Study rationale ............................................................................................................................................. 8 
Study Procedure:.......................................................................................................................................... 8 
Follow-Up Schedule: .................................................................................................................................... 8 
Data Management and Monitoring: ............................................................................................................ 8 
Ethics and Regulatory Compliance: ............................................................................................................. 9 
Statistical Analysis Plan (SAP): ..................................................................................................................... 9 
Withdrawal, discontinuation, and/or replacement of subjects .................................................................. 9 
Safety Reporting........................................................................................................................................... 9 
Adverse Events Reporting ............................................................................................................................ 9 
Follow-up of SAEs ....................................................................................................................................... 12 
Organization ............................................................................................................................................... 12 
Sponsor .................................................................................................................................................. 12 
Clinical Investigator: ............................................................................................................................... 12 
Quality Control and Quality Assurance ...................................................................................................... 12 
Monitoring ............................................................................................................................................. 12 
Record retention .................................................................................................................................... 12 
Publication policy ................................................................................................................................... 13 
REFERENCES ............................................................................................................................................... 13 

 
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PROTOCOL APPROVAL PAGE 
 
Study title: A Multicenter Prospective Clinical Study to Evaluate the Safety and Performance of the Mamba 
Sirolimus-Coated Drug-Coated Balloon (DCB) for the Treatment of Obstructive Coronary Artery Disease 
(MIRAGE Study). 
Name of Study: MIRAGE 
Protocol version: ECS/FM/030603 
We, the undersigned, have read and approved the protocol specified above, and agree to adhere 
to its requirements outlined within: 
 
A. Clinical Investigator 
 
          
 
 
 
                                           01.02.2023 
                                                                                                        Date                                                                              
B. Sponsor Representative 
 
       Mr. Bhavin Oza 
 
          CEO 
Frisch Medical Devices PVT LTD       
Email: frischmedical@gmail.com 
Email: info@frischmedical.com 
 
 
 
 
 
 
 
 
 
 
 
                                                                                                                                                                                                                                                          01.02.2023 
 
           Signature                                                                                Date 
 
 
 
 
 
 

 
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PROTOCOL SUMMARY 
Protocol No.: ESC/FM/030603 
Version: 01 
Sponsor:  Frisch Medical Devices Private Limited 
Device: Mamba Sirolimus Drug-Eluting PTCA Balloon 
Study Type: Clinical Investigation to Support Clinical Evaluation Report (CER)  
Purpose: Clinical Evaluation for Safety and efficacy of the Sirolimus Coated DCB  
Regions: Multicenter – Malaysia, Myanmar  
Study Design: Prospective, Non-Randomized, Single-Arm 
Study Duration: 12 months follow-up per patient 
Study Objectives: 
Primary Objective:  
To evaluate 30-day MACE following treatment with the Mamba Sirolimus DCB. 
Secondary Objectives: 
Device success, procedural success, angioplasty outcomes, MACE at 6/12 months, TLR at 6/12 months, SAEs, 
MACE-free survival. 
Endpoints: 
Primary Endpoint: 
MACE at 30 days. 
Secondary Endpoints: 
Device success, procedural success, post-usage angioplasty results, MACE at 6/12 months, TLR, TVR, SAEs, 
MACE-free survival. 
Study Population: 
Sample Size: 360 subjects  
Inclusion/Exclusion criteria: 
Inclusion Criteria: 
 
Those subjects eligible for and who met the following inclusion/exclusion criteria were enrolled in this study. 
1. Adults ≥18 yrs,  
2. Clinical indication for PCI  
3. suitable lesion for DCB-only strategy 
4. small vessel disease 
5. Patient has clinical evidence of ischemic heart disease or a positive functional study 
6. Patient and his or her treating physician agree that the patient will comply with all the required post-
procedure follow-up.  

 
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7. One or more target lesions require treatment 
Exclusion Criteria: 
Patients were excluded if ANY of the following conditions apply: 
1. Patient has active infection 
2. STEMI <72 hrs, LM disease,  
3. heavy calcification, thrombus-rich lesions,  
4. mandatory stent requirement,  
5. sirolimus allergy, pregnancy,  
6. Concurrent medical condition with a life expectancy <1 yr 
7. Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate, or ticlopidine 
including thrombocytopenia, neutropenia, or leukopenia 
8. Active peptic ulcer or upper gastrointestinal bleeding. 
9. Current participation in an investigational drug or device trial that has not completed its primary 
endpoint follow-up period. 
10. Pregnancy or woman of childbearing potential who, in the opinion of the investigator, does not take 
adequate measures to prevent conception 
 
Study Design: 
 
Comparative Arm: None (no randomization) 
Centers: Multicenter – Malaysia, Myanmar  
Study Duration: 12 months follow-up per patient 
Introduction  
 
The Mamba Rapid Exchange Sirolimus Coated Dilatation Catheter is a rapid exchange, PTCA catheter 
with a balloon located at its end designed for Transluminal angioplasty by percutaneous way. This 
catheter includes distally two coaxial lumens with a balloon located at the tip. One lumen is used for 
inflation of the balloon and the other permits the use of guide wire (0.014”max) to facilitate the 
advancement of the catheter to and through the stenosis to be dilated. The MAMBA Rapid Exchange 
Sirolimus Coated Dilatation Catheter has flexible distal shaft with a hydrophilic coating on its outer body. 
The balloon has two Platinum-Iridium radiopaque marker bands, one at each end of the balloon, which 
represents the approximate balloon working length at nominal pressure for correctly positioning the 
balloon under fluoroscopy. 
 
Mamba is a Sirolimus Coated Dilatation Catheter for the treatment of coronary artery disease, indicated 
for In-Stent Restenosis, Small Vessels and Bifurcation Lesions. Sirolimus Coated Dilatation Catheter 
(DCB) is a novel device for Percutaneous Coronary Intervention (PCI), which has demonstrated favorable 
outcome due to its peculiar characteristic of a high-concentration, rapid local delivery of an anti-
restenotic drug without the use of a durable polymer or metal stent. 
 
 

 
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Drug Sirolimus 
 
Mamba Sirolimus Drug Eluting PTCA Catheter has a drug loading of 2.75 μg/mm2 of balloon surface area 
coated with Sirolimus as the active anti-proliferative agent.  
 
Mechanism of Action for Sirolimus: 
 
The mechanism by which the Sirolimus Coated Dilatation Catheter inhibits neointimal growth as seen in 
pre-clinical and clinical studies has not been established. At the cellular level, Sirolimus inhibits growth 
factor-stimulated cell proliferation. At the molecular level, Sirolimus forms a complex with the 
cytoplasmic protein FKBP-12 (FK 506 Binding Protein). This complex binds to and interferes with FKBP-
12 Rapamycin Associated Protein (FRAP), also known as the mammalian target of rapamycin (mTOR), 
leading to inhibition of cell metabolism, growth, and proliferation by arresting the cell cycle at the late 
G1 stage. 
It inhibits growth factor & cytokine-stimulated cell proliferation. DNA damage checkpoint (G1 
check):chk1-kinase inactivation before DNA replication and also inactivation of cdk2- cyclin a protein 
(growth factor). 
 
 
 
 
 
 
 
 
 

 
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Balloon 
 
A 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. 
 
 
 
Available Sirolimus Drug Eluting PTCA Catheter Sizes 
Diameters 
(mm) 
Available Lengths (mm) 
1.50 
06 
08 
10 
12 
15 
20 
25 
30 
35 
40 
2.00 
06 
08 
10 
12 
15 
20 
25 
30 
35 
40 
2.25 
06 
08 
10 
12 
15 
20 
25 
30 
35 
40 
2.50 
06 
08 
10 
12 
15 
20 
25 
30 
35 
40 
2.75 
06 
08 
10 
12 
15 
20 
25 
30 
35 
40 
3.00 
06 
08 
10 
12 
15 
20 
25 
30 
35 
40 
3.50 
06 
08 
10 
12 
15 
20 
25 
30 
35 
40 
4.00 
06 
08 
10 
12 
15 
20 
25 
30 
35 
40 
 
 
 
 
 

 
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Study rationale 
 
This is a multi-center; prospective study aimed at evaluating the safety and effectiveness of the Mamba 
Sirolimus Drug Eluting PTCA Catheter in reducing neointimal hyperplasia and decreasing restenosis 
during PCI of stenotic coronary artery disease as well as intermediate-term outcomes. High Radial 
Strength, Excellent conformability, and Sirolimus eluting characteristics. A Drug Eluting PTCA Catheter 
of this type is expected to decrease restenosis following PCI and thereby improve Clinical Outcomes. 
 
Study Procedure: 
 
Baseline evaluation, index PCI procedure, device success, procedural success, post-angioplasty results. 
Follow-up at 1, 6, 12 months (clinical only). 
 
Screening and eligibility check 
Informed consent 
Baseline assessment (demographics, ECG, labs, angina class) 
Index DCB procedure (balloon angioplasty using Sirolimus-coated DCB) 
Pre-dilatation of the target lesion with an appropriate semi-compliant or non-compliant balloon is 
mandatory. Only lesions with successful pre-dilatation—defined as TIMI 3 flow, no flow-limiting dissection, 
and ≤30% residual stenosis—are eligible for DCB deployment." 
No stent implantation unless medically necessary (bailout) 
Discharge as per hospital protocol 
Follow-up visits at 1, 6, and 12 months for clinical evaluation, ECG, and adverse event assessment 
 
 
Follow-Up Schedule: 
 
Timepoint 
Visit Type 
Assessments 
Day 0 
Baseline 
Demographics, consent, eligibility, angina class, ECG, labs 
Day 1 
Procedure 
DCB implantation, procedural outcomes 
1 Month 
Clinic visit 
MACE, adverse events, ECG, medication adherence 
6 Months 
Clinic/Tele 
MACE, TLR, adverse events, angina class 
12 Months 
Final visit 
MACE, TLR, SAE reporting, device durability 
 
Data Management and Monitoring: 
Use of Electronic Data Capture (EDC) 
On-site and remote monitoring 
Centralized adjudication of endpoints by Clinical Events Committee (CEC) 
Safety reviewed periodically by an independent Data Monitoring Committee (DMC) if required 

 
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Ethics and Regulatory Compliance: 
 
Conforms to ISO 14155:2020 and Declaration of Helsinki 
Ethics Committee/IRB approvals mandatory at each site 
Adverse events reported to regulatory bodies per local laws 
Fully anonymized patient data to protect confidentiality 
Statistical Analysis Plan (SAP): 
 
ITT and PP populations.  
Descriptive statistics for baseline and outcome data 
95% CI for MACE. Kaplan–Meier for survival 
Exploratory subgroup analysis. 
No formal hypothesis testing due to non-comparative design 
Subgroup analysis 
No subgroup analyses are planned. 
Withdrawal, discontinuation, and/or replacement of subjects 
 
All patients have the right to withdraw at any point during the period of the clinical study. It will be 
documented whether or not each patient completed the clinical study Every attempt should be made 
to collect follow-up information. Discontinued patients will not be replaced. 
Safety Reporting 
AE, SAE, and device deficiency reporting according to ISO 14155. 
Adverse Events Reporting  
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, Sirolimus Drug Eluting PTCA Catheter, 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 Sirolimus Drug Eluting PTCA Catheter procedure: 
1. 
Allergic/immunologic reaction to anticoagulant and/or antithrombotic therapy 
2. 
agents or contrast medium 
3. 
Aneurysm 
4. 
Arrhythmia’s (bradycardia, rhythmical disturbances) 
5. 
Arterial perforation 
6. 
Bleeding complications 
7. 
Cardiac tamponade 
8. 
Cardiogenic shock 
9. 
Death 
10. Dissection 
 

 
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11. Drug reactions to antiplatelet agents/ anticoagulation agents/contrast medium 
12. Emboli (tissue, air or thrombic 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. Stroke 
37. Thrombosis (acute, subacute or late) 
38. Unstable Angina Pectoris 
39. Vascular complications, which may require vessel repair 
40. Ventricular fibrillation 
41. Vessel spasm 
The following Anticipated Events have been identified as possible complications of 
Sirolimus coating: 
1. Allergic/immunologic reaction to drug 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 

 
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10. Peripheral neuropathy 
The following Anticipated Events have been identified as possible complications of the medicine 
Sirolimus: 
1. 
Change in taste 
2. 
Change in color of the nails 
3. 
Change in normal bowel habits for more than 2 days 
4. 
Chest pain 
5. 
Chills 
6. 
Cough 
7. 
Difficulty swallowing 
8. 
Dizziness 
9. 
Facial flushing 
10. Fatigue 
11. Fever 
12. Loss of appetite 
13. Mouth blistering 
14. Nausea and vomiting 
15. Pain in the joints of the arms or legs lasting 2-3 days 
16. Pain, redness, or swelling at the injection site 
17. Severe exhaustion 
18. Shortness of breath 
19. Skin rash 
20. Sore throat 
21. Tingling in the hands or toes 
22. Thinned or brittle hair 
23. Unusual bruising or bleeding 
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 study, 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. 
 
Reporting of (Serious) Adverse Events 
 

 
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All AEs and SAEs since randomization must be recorded in the CRF and source documents. All SAEs or 
unanticipated adverse device effects (ADE) must be reported to Frisch Medical immediately (within 24 
hours) by email. 
Follow-up of SAEs 
 
All adverse events occurring during the study 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 Private Limited. 
Organization  
Sponsor 
Frisch Medical Devices PVT LTD. 
B 303, Titanium Square, Thaltej Cross Roads 
Ahmedabad 
Gujarat. India 
 
Clinical Investigator:  
 
Dr. Tay Mok Heang DNS, ANS, PJK 
MBBS (MaI), MRCP (UK), M.MED (S’pore) 
FAMS (Cardiology, S’pore), AM (MaI) 
Consultant Cardiologist & Physician 
Sunway Heart & Vascular Institute, Malaysia 
(MMC No.: 31581) (NSR No: 125290) 
 
Quality Control and Quality Assurance  
 
Monitoring 
 
Monitoring visits, source verification, query resolution. 
Trained and qualified personnel from the Sponsor will monitor the study throughout its duration by means 
of One personal visit to the Investigator’s facilities and by other communication.  
- the progress of the study, 
- verify whether the reported clinical study data are accurate, complete, and verifiable from source 
documents, 
- Whether the protocol and applicable amendments are being followed. 
Record retention 
The investigator should maintain the essential clinical study 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 study documents should be retained for a 

 
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minimum of two years after the last approval of the marketing application, or at least five 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 
study records, custody must be transferred to a person who will accept responsibility. 
 
Publication policy 
 
The Sponsor and Investigators are committed to the publication and widespread dissemination of the results 
of the study. This study 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 study must be submitted to the Steering Committee for review and approval before 
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 to pursue such protection. 
REFERENCES 
 
1. 
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. 
2. 
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. 
3. 
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. 
4. 
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. 
5. 
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. 
6. 
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. 
7. 
Waksman R, Bhargava B, Leon MB. Late thrombosis following intracoronary brachytherapy. Catheter Cardiovasc Interv. 
2000; 49: 344-7. 
8. 
Castagna MT, Mintz GS, Weissman N, Maehara A, Finet G, Waksman R. "Black hole": echolucent restenotic tissue after 
brachytherapy. Circulation 2001; 103: 778. 
9. 
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. 
10. Rowinsky E K, Donehower R C. Everolimus (taxol). N Engl. J Med. 1995; 332:1004- 1014. 
11. 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. 
12. 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. 
13. 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. 
14. 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. 
15. Frab A, Heller PF, Carter AJ, et al. Paclitaxel  polymer-coated  stents  reduce  neointima. Circulation 1997; 96: I-608. 
16. 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 
17. Korjian, S., McCarthy, K.J., Larnard, E.A., Cutlip, D.E., McEntegart, M.B., Kirtane, A.J. and Yeh, R.W., 2024. Drug-coated 
balloons in the management of coronary artery disease. Circulation: Cardiovascular Interventions, 17(5), p.e013302 

 
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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 Thrombosis/Occlusion: Angiographic 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. 
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 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. 

 
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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. 
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 
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. 

 
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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). 
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 Vessel Diameter): 
Interpolated reference 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 hospitalization 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.