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

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 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.