The OMEGA Clinical Trial

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:

1. If CK MB >2× upper limit of normal (ULN), the subject is excluded regardless of
the CK Total.

2. If CK Total >2× ULN, CK-MB must be drawn and the subject is excluded if CK-MB is
abnormal.

3. 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.