Sapphire II PRO - A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Acute Safety and Device Procedural Success of the Sapphire II PRO 1.0 and 1.25 mm PTCA Dilatation Catheters.
Phase: NA
Conditions: Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases
Sponsor: OrbusNeich

Sapphire II PRO  
Sapphire II PRO US Clinical Study Protocol 1.0mm and 1.25mm 
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PROTOCOL VERSION AND AMENDMENT TRACKING 
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Protocol Summary 
Study Design and Rationale
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Investigator Statement


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Table of Contents 
1. General Information ................................................................................................12 
1.1. Principal Investigator .......................................................................................12 
1.2. Site Management, Data Coordination and Monitoring ................................12 
1.3. Clinical Events Committee ...............................................................................12 
1.4. Angiographic Core Laboratory .......................................................................12 
1.5. Sponsor ..............................................................................................................13 
2. Background Information.........................................................................................13 
2.1. Description of Investigational Device ..............................................................13 
2.2. Summary of Findings from Non-Clinical Studies ..........................................14 
2.3. Summary of Known and Potential Risks and Benefits .................................14 
2.4. Statement of Trial Conduct .............................................................................15 
2.5. Study Population ...............................................................................................15 
2.6. Summary of Relevant Literature ....................................................................15 
3. Trial Objectives and Purpose .................................................................................16 
4. Trial Design ..............................................................................................................16 
4.1. Selection and Withdrawal of Subjects ............................................................16 
4.2. Inclusion Criteria ..............................................................................................16 
4.3. Exclusion Criteria .............................................................................................17 
4.4. Subject Withdrawal Criteria ...........................................................................18 
5. Treatment of Subjects..............................................................................................18 
5.1. Non-Target Lesion ............................................................................................18 
5.2. Target Lesion ....................................................................................................18 
5.3. Study Procedures ..............................................................................................20 
6. Assessments of Safety and Efficacy ........................................................................21 
6.1. Primary end-point ............................................................................................22 
6.2. Secondary end-points .......................................................................................22 
6.3. Angiographic Core Laboratory .......................................................................23 
6.4. Clinical Events Adjudications .........................................................................23 
7. Adverse Events .........................................................................................................23 
7.1. Serious Adverse Events ....................................................................................23 
7.2. Anticipated Adverse Device Effects ................................................................24 
7.3. Unanticipated Adverse Device Effects ............................................................24 
8. Device Failure and Device Malfunction .................................................................24 
9. Statistics ....................................................................................................................24 
10. Direct Access to Source Data/Documents ..............................................................25 
11. Quality Control and Quality Assurance ................................................................25 
11.1 Selection of Clinical Sites and Investigator ...................................................25 
11.2 Protocol and Informed Consent Approval ....................................................25 
11.3 Protocol Deviations ..........................................................................................26 
11.4 Training ............................................................................................................26 
11.5 Good Clinical Practice Compliance ...............................................................27 
11.6 Monitoring ........................................................................................................27 
11.7 Quality Assurance Assessments ......................................................................27 
11.8 Regulatory Agency Inspection ........................................................................28 

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11.9 Executive Committee .......................................................................................28 
12 Ethics ........................................................................................................................28 
13 Data Handling and Record Keeping .....................................................................28 
13.1 Source Documentation ....................................................................................29 
13.2 Case Report Form (CRF) Completion ...........................................................29 
13.3 Record Retention .............................................................................................29 
13.4 Investigational Device Management ..............................................................29 
13.5 Close-Out Visit .................................................................................................30 
14 Insurance .................................................................................................................30 
15 Publication Policy....................................................................................................30 
16 Bibliography ............................................................................................................32 
 
 

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Abbreviations 
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1. General Information 
1.1. Principal Investigator 
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1.3. Clinical Events Committee 
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1.4. Angiographic Core Laboratory 
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1.5. Sponsor 
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2. Background Information 
2.1. Description of Investigational Device 
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2.2. Summary of Findings from Non-Clinical Studies 
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2.3. Summary of Known and Potential Risks and Benefits 
2.3.1. Potential Risks 
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2.3.2. Risk Management 
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2.3.3. Potential Benefit 
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2.4. Statement of Trial Conduct 
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2.6. Summary of Relevant Literature 
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3. Trial Objectives and Purpose 
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4. Trial Design 

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4.2 Inclusion Criteria 
4.2.1 Clinical Inclusion Criteria 
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4.2.2 Angiographic Inclusion Criteria 
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x D8O@DLDF=KNFC<J@FEJ@E:CL;@E>8KC<8JKFE<K8I><KC<J@FE@ELGKF
KNF:FIFE8IP8IK<I@<J

x .8I><K8E;EFE	K8I><KC<J@FEJDLJK9<CF:8K<;@E;@==<I<EK:FIFE8IP8IK<I@<J
FI9PG8JJ>I8=KJ

x .8I><KC<J@FEJDLJK?8M<8;@8D<K<IJK<EFJ@JF=9PM@JL8C
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x .I<8KD<EKF=EFE	K8I><KC<J@FE@=8EPDLJK9<:FDGC<K<;GI@FIKF
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4.3 Exclusion Criteria 
4.3.1 Clinical Exclusion Criteria 
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x *C8EE<;FI8:KL8CK8I><KC<J@FEKI<8KD<EKN@K?8ELE8GGIFM<;;<M@:<
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4.3.2 Angiographic Exclusion Criteria 
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4.4 Subject Withdrawal Criteria 
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5 Treatment of Subjects 

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5.1 Non-Target Lesion 
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Table 1.0 
Schedule of Procedures 
 
Screening and 
Pre-Enrollment 
Enrollment and / 
Pre-dilatation 
Procedure 
Postprocedure 
Discharge 
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5.3 Study procedures 
 
5.3.1 Written Informed Consent 
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5.3.2 Within 24 hours Prior to Index Procedure 
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7 Adverse Events 
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8 Device Failure and Device Malfunction 
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9  Statistics 
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10 Direct Access to Source Data/Documents 

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11   Quality Control and Quality Assurance 
11.1 
Selection of Clinical Sites and Investigator 
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11.2 
Protocol and Informed Consent Approval  
11.2.1 Protocol/Subject Informed Consent Initial Approval 
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11.2.2 Protocol/Subject Informed Consent Approval of Amendments 
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11.3 
Protocol Deviations 
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11.4 
Training 
11.4.1 Site Training 
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11.4.2 Training of Sponsor’s Monitors 
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11.5 
Good Clinical Practice Compliance 
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11.6 
Monitoring 
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11.7 
Quality Assurance Assessments 
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11.8 
Regulatory Agency Inspection 
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11.9 
Executive Committee 
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12    Ethics 
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13     Data Handling and Record Keeping 
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13.1 
Source Documentation 
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13.2 
Case Report Form (CRF) Completion 
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13.3 
Record Retention 
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13.4.1 Investigational Device Accountability 
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14    Insurance 
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15   Publication Policy 
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16    Bibliography 
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