A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s)

Clinical 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

- Subject is eligible for percutaneous coronary intervention (PCI) and is an acceptable
candidate for coronary artery bypass grafting (CABG)

- Subject has either:

- Symptomatic coronary artery disease with one of the following: stenosis ≥ 70%,
abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test,
or elevated biomarkers prior to the procedure

- OR

- Documented silent ischemia based on one of the following: abnormal fractional
flow reserve (FFR), abnormal stress or imaging stress test, or elevated
biomarkers prior to the procedure

- Subject is willing to comply with all protocol-required follow-up evaluation
Angiographic Inclusion Criteria (visual estimate)

- Target lesion must be located in a native coronary artery with a visually estimated
reference vessel diameter (RVD) ≥2.5 mm and ≤4.0 mm

- Target lesion length must be >34 mm and ≤44 mm (by visual estimate)

- Target lesion must have visually estimated stenosis ≥50% and <100% with thrombolysis
in Myocardial Infarction (TIMI) flow >1

- Coronary anatomy is likely to allow delivery of a study device to the target lesion

- The target lesion must be successfully predilated/pretreated. If a non-target lesion
is treated, it should be treated first and should be deemed an angiographic success
Note: Angiographic success is a mean lesion diameter stenosis < 50% (< 30% for stents)
in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the
physician, without the occurrence of prolonged chest pain or ECG changes consistent
with MI.

Note: Successful predilatation/pretreatment refers to dilatation with a balloon catheter of
appropriate length and diameter, or pretreatment with directional or rotational coronary
atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis
and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.

Clinical 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 enrollment):

- 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 signs or symptoms of active heart failure (i.e., NYHA class IV) at the
time of the index procedure

- 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 Angiographic Exclusion Criteria (visual
estimate)

- 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 Note: Multiple focal stenoses
will be considered as a single lesion if they can be completely covered with 1 study
stent

- Treatment of lesions in more than 2 major epicardial vessels Note: 1 target lesion in
the target vessel and 1 non-target lesion in non-target vessel is allowed

- 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)

- Target lesion meets any of the following criteria:

- Treatment of a single lesion with more than 1 stent

- Left main location

- Lesion 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

- Lesion is located within a saphenous vein graft or an arterial graft

- Lesion will be accessed via a saphenous vein graft or arterial graft

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

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

- Lesion is restenotic from a previous stent implantation or study stent would overlap
with a previous stent

- Non-target lesion meets any of the following criteria:

- Located within the target vessel

- Left main location

- Lesion is located within a saphenous vein graft or an arterial graft

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

- Lesion treated during the index procedure that involves a complex bifurcation (e.g.,
bifurcation lesion 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 an angiographic success Note: Angiographic success is a mean
lesion diameter stenosis < 50% (< 30% for stents) in 2 near-orthogonal projections
with TIMI 3 flow, as visually assessed by the physician, without the occurrence of
prolonged chest pain or ECG changes consistent with MI.