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., New York Heart Association (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.