The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)

A concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy and a consecutive,
non-randomized, single-arm, Diabetes substudy will also enroll under the EVOLVE II protocol.

Inclusion Criteria:

- Subject must be at least 18 years of age

- Subject (or legal guardian) understands the trial requirements and the treatment
procedures and provides written informed consent before any trial-specific tests or
procedures are performed

- For subjects less than 20 years of age enrolled at a Japanese site, the subject and
the subject's legal representative must provide written informed consent before any
study-specific tests or procedures are performed

- Subject is eligible for percutaneous coronary intervention (PCI)

- Subject has symptomatic coronary artery disease with objective evidence of ischemia or
silent ischemia

- Subject is an acceptable candidate for coronary artery bypass grafting (CABG)

- Subject is willing to comply with all protocol-required follow-up evaluation

Angiographic Inclusion Criteria (visual estimate):

- Target lesion(s) must be located in a native coronary artery with a visually estimated
reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm

- Target lesion(s) length must be ≤34 mm (by visual estimate)

- Target lesion(s) must have visually estimated stenosis ≥50% and <100% with
thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following:
stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging
stress test, or elevated biomarkers prior to the procedure

- Coronary anatomy is likely to allow delivery of a study device to the target
lesions(s)

- The first lesion treated must be successfully predilated/pretreated

Exclusion Criteria:

- Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with
acute ST elevation MI (STEMI)

- Subject has cardiogenic shock, hemodynamic instability requiring inotropic or
mechanical circulatory support, intractable ventricular arrhythmias, or ongoing
intractable angina

- Subject has received an organ transplant or is on a waiting list for an organ
transplant

- Subject is receiving or scheduled to receive chemotherapy within 30 days before or
after the index procedure

- Planned PCI (including staged procedures) or CABG after the index procedure

- Subject previously treated at any time with intravascular brachytherapy

_ Subject has a known allergy to contrast (that cannot be adequately premedicated)
and/or the trial stent system or protocol-required concomitant medications (e.g.,
platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related
compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)

- Subject has one of the following (as assessed prior to the index procedure):

- Other serious medical illness (e.g., cancer, congestive heart failure) with
estimated life expectancy of less than 24 months

- Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)

- Planned procedure that may cause non-compliance with the protocol or confound
data interpretation

- Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., 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 baseline serum creatinine level >2.0 mg/dL (177µmol/L)

- Subject has a history of bleeding diathesis or coagulopathy or will refuse blood
transfusions

- Subject has had a history of cerebrovascular accident (CVA) or transient ischemic
attack (TIA) within the past 6 months

- Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding

- Subject has severe symptomatic heart failure (i.e., NYHA class IV)

- Subject is participating in another investigational drug or device clinical trial that
has not reached its primary endpoint

- Subject intends to participate in another investigational drug or device clinical
trial within 12 months after the index procedure

- Subject with known intention to procreate within 12 months after the index procedure
(women of child-bearing potential who are sexually active must agree to use a reliable
method of contraception from the time of screening through 12 months after the index
procedure)

- Subject is a woman who is pregnant or nursing (a pregnancy test must be performed
within 7 days prior to the index procedure in women of child-bearing potential)

Angiographic Exclusion Criteria (visual estimate):

- Planned treatment of more than 3 lesions

- Planned treatment of lesions in more than 2 major epicardial vessels

- Planned treatment of a single lesion with more than 1 stent

- Subject has 2 target lesions in the same vessel that are separated by less than 15 mm
(by visual estimate)

- Target lesion(s) is located in the left main

- Target lesion(s) is located within 3 mm of the origin of the left anterior descending
(LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate

- Target lesion(s) is located within a saphenous vein graft or an arterial graft

- Target lesion(s) will be accessed via a saphenous vein graft or arterial graft

- Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide
wire crossing

- Target lesion(s) treated during the index procedure that involves a complex
bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)

- Target lesion(s) is restenotic from a previous stent implantation or study stent would
overlap with a previous stent

- Subject has unprotected left main coronary artery disease (>50% diameter stenosis)

- Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent,
cutting balloon atherectomy) within 24 hours prior to the index procedure

- Thrombus, or possible thrombus, present in the target vessel (by visual estimate)