Sapphire II PRO US Clinical Study

Study Overview
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Brief Summary
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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 in subjects with stenotic coronary arteries or bypass grafts during percutaneous coronary intervention. Sixty (60) subjects will be treated at up to 5 U.S. sites with the Sapphire II PRO diameters 1.0 and 1.25 mm PTCA dilatation catheters to pre-dilate coronary arteries or bypass grafts during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.

Official Title
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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.

Conditions
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Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases

Intervention / Treatment
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* Device: Sapphire II PRO


Participation Criteria
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Eligibility Criteria
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Clinical Inclusion Criteria: Subject is ≥ 18 years of age. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study. Subjects must have a single or double vessel coronary artery disease and clinical evidence of ischemic heart disease, such as stable / unstable angina or silent ischemia. Angiographic Inclusion Criteria Subject must have de novo or restenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention. An embolic protection device must be used in all Saphenous venous grafts (SVG) interventions performed during the index procedure. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries. Target and non-target lesions must be located in different coronary arteries or bypass grafts. Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation and may include chronic total occlusions (CTO) Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success. Clinical Exclusion Criteria: Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated. Subject with known diagnosis of an acute myocardial infarction (AMI) within 72 hours prior to index procedure. Subject with known pregnancy or is nursing. Women of child- bearing potential should have a documented negative pregnancy test within 7 days before index procedure. Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure. A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure. Cerebrovascular accident (CVA) within the past 6 months. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months. Subject has a known left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary) Angiographic Exclusion Criteria More than two lesions requiring treatment. Unprotected left main coronary artery disease.(Greater than 50% diameter stenosis) Coronary artery spasm of the target vessel in the absence of a significant stenosis. Target lesion with angiographic presence of probable or definite thrombus. Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.0 mm in diameter. Non-target lesion to be treated during the index procedure meets any of the following criteria: Located within a bypass graft (venous or arterial) Left main location Chronic total occlusion Involves a bifurcation (e.g., bifurcations requiring treatment with more than 1 stent) Treatment not deemed a clinical angiographic success

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sapphire II PRO<br>Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters | Device: Sapphire II PRO<br>* To pre-dilate coronary arteries or bypass grafts during the subject's index procedure with Sapphire II PRO 1.0 and 1.25 PTCA dilatation catheters.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Device Procedural Success | Device procedural success consisting of the following: Successful delivery, inflation, deflation and withdrawal of the study balloon No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon Final TIMI flow grade of 3 at the conclusion of the PCI procedure | Peri-procedural (at Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) | In-hospital Major Adverse Cardiac Events (MACE) All death (cardiac and non-cardiac) Myocardial infarction (MI) Target Lesion Revascularization (TLR) | Endpoints will be measured through hospital discharge (expected to be within 24 hours) | 
| Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel | In-hospital stent thrombosis (ST) within the target vessel | Endpoint will be measured through hospital discharge (expected to be within 24 hours) | 
| Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention) | Clinically Significant Arrhythmias (requiring intervention) | Endpoint will be measured through hospital discharge (expected to be within 24 hours) |