The OMEGA Clinical Trial

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of the OMEGA Coronary Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery lesion.

Official Title
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OMEGA: A Prospective, Multicenter Single-Arm Trial to Assess the OMEGA™ Coronary Stent System for the Treatment of a Single De Novo Coronary Artery Lesion

Conditions
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Atherosclerosis, Coronary Artery Disease

Intervention / Treatment
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* Device: OMEGA™ Monorail Coronary Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be at least 18 years of age. Subject (or legal guardian) indicates understanding of the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed. Subject is eligible for percutaneous coronary intervention (PCI). Subject has symptomatic coronary artery disease or documented silent ischemia. Subject is an acceptable candidate for coronary artery bypass grafting (CABG). Subject has a left ventricular ejection fraction (LVEF) ≥30% as measured within 60 days prior to enrollment. Subject is willing to comply with all protocol-required follow-up evaluations. Angiographic Inclusion Criteria: Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.25 mm and ≤4.5 mm. Target lesion length must measure (by visual estimate) as follows: ≤28 mm for stent diameter lengths of 2.75 mm, 3.00 mm, 3.50 mm, 4.00 mm and 4.50 mm ≤24 mm for stent diameter lengths of 2.25 mm and 2.50 mm Target lesion must be in a major coronary artery or branch with visually estimated stenosis ≥50% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow >1. Target lesion must be successfully pre-dilated. Exclusion Criteria: Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI). Subject with unstable angina or recent MI (clinically diagnosed within 3 days) must have creatine kinase (CK)/ creatine kinase-myoglobin band(CK-MB) or troponin documented prior to the procedure and are excluded if any of the following criteria are met at the time of the index procedure: If CK MB >2× upper limit of normal (ULN), the subject is excluded regardless of the CK Total. If CK Total >2× ULN, CK-MB must be drawn and the subject is excluded if CK-MB is abnormal. If CK/CK-MB results are not available at the time of procedure, the subject is excluded if troponin >1× ULN and the subject has at least one of the following: Subject has ischemic symptoms and ECG changes indicative of ongoing ischemia (e.g., >1 mm stent thrombosis (ST) segment elevation or depression in consecutive leads or new left bundle branch block [LBBB]) Development of pathological Q waves in the ECG or; Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality Note: Subjects who do not have unstable angina or recent MI must still have CK/CK-MB drawn prior to the index procedure. However, the results for these subjects do not need to be available prior to the index procedure and there are no exclusion criteria based on these studies. Subject is receiving chronic (≥72 hours) anticoagulation therapy (e.g., heparin, coumadin) for indications other than acute coronary syndrome. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3. Subject has a white blood cell (WBC) count <3,000 cells/mm3. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis. Subject is on dialysis or has known renal insufficiency (e.g. serum creatinine level >2.0 mg/dL). Subject has active peptic ulcer disease, an active gastrointestinal (GI) bleed, other bleeding diathesis or coagulopathy or will refuse transfusions. Subject has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol. Target vessel (including side branches) has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to the index procedure. Target vessel has been treated within 10 mm proximal or distal to the target lesion (by visual estimate) with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, or atherectomy) at any time prior to the index procedure. Non-target vessel or side branch has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 1 day prior to the index procedure. Note: 1 lesion in a non-target vessel may be treated during the index procedure prior to the treatment of the target (study) lesion. Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement. Planned PCI or CABG after the index procedure. Subject previously treated at any time with coronary intravascular brachytherapy. Subject has known allergy to the study stent system or protocol-required concomitant medications (e.g., stainless steel, platinum, chromium, nickel, iron, thienopyridines and acetylsalicylic acid (ASA)) and contrast (that cannot be adequately premedicated). Subject has any other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months. Subject has current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.). Subject has a planned procedure that may cause non-compliance with the protocol or confound data interpretation. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint or intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure. Subject is female of childbearing potential with a positive pregnancy test within 14 days before the index procedure, is lactating, or intends to become pregnant during the study. Subject has more than 1 target lesion, or more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure. Angiographic Exclusion Criteria: Target lesion meets any of the following criteria: Aorto-ostial location (i.e., lesion located within 5 mm of the ostium by visual estimate) Left main location Located within 5 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery or Right Coronary Artery (RCA) by visual estimate Located within a saphenous vein graft or an arterial graft Will be accessed via a saphenous vein graft or an arterial graft Involves a side branch ≥2.0 mm in diameter by visual estimate Involves a side branch <2.0 mm in diameter by visual estimate that has a clinically significant stenosis at the ostium TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing Excessive tortuosity proximal to or within the lesion Extreme angulation proximal to or within the lesion Target lesion and/or target vessel proximal to the target lesion is moderately to severely calcified by visual estimate Restenotic from previous intervention Thrombus, or possible thrombus, present in the target vessel Target lesion cannot be covered by a single study stent (unplanned bailout stenting is allowed) Non-target lesion to be treated during the index procedure meets any of the following criteria: Located within the target vessel Located within a bypass graft (venous or arterial) Left main location Chronic total occlusion Involves a complex bifurcation (e.g., bifurcations requiring treatment with more than 1 stent) Requires additional unplanned stents (treatment of the non-target lesion with more than one stent is permitted as long as the stents are initially planned) Treatment not deemed a clinical angiographic success Treatment not completed prior to treatment of target lesion Subject has unprotected left main coronary artery disease (>50% diameter stenosis). Subject has protected left main coronary artery disease and a target lesion in the LAD or LCX. Subject has an additional clinically significant lesion(s) in the target vessel for which an intervention within 12 months after the index procedure may be required.

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: OMEGA™ Monorail Coronary Stent System<br> | Device: OMEGA™ Monorail Coronary Stent System<br>* All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 9-month Target Lesion Failure (TLF) Rate | The primary endpoint is 9-month target lesion failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), Myocardial Infarction (MI) (Q-wave and non-Q-wave) related to the target vessel, or cardiac death. | Nine Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 Month Target Lesion Revascularization (TLR) Rate | Any ischemia-driven repeat percutaneous coronary intervention (PCI), to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 
| 12 Month Target Vessel Revascularization (TVR) Rate |  | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 
| 12 Month Target Vessel Failure (TVF) Rate | Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 
| 12 Month Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate |  | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 
| 12 Month Cardiac Death Rate |  | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 
| 12 Month Non-cardiac Death Rate |  | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 
| 12 Month All Death Rate |  | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 
| 12 Month Cardiac Death or MI Rate |  | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 
| 12 Month All Death or MI Rate |  | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 
| 12 Month All Death/MI/TVR Rate |  | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 
| 12 Month Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions) |  | Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months | 
| Periprocedural Endpoints: Technical Success Rate | Technical success: successful delivery and deployment of the study stent to the target vessel, without balloon rupture or embolization. Summarized per attempted study stent. | Participants will be followed for the duration of hospital stay, an expected average of 1 day | 
| Clinical Procedural Success Rate | Clinical Procedural Success: lesion diameter stenosis < 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death. Summarized per patient. | Participants will be followed for the duration of hospital stay, an expected average of 1 day |