FAST Feasibility Study

Exclusion Criteria

• •Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI
• •Subjects with unstable angina or recent MI (clinically diagnosed within the past 2 weeks) must have cardiac troponin (cTn) documented prior to the procedure and are excluded if cTn is \> 5x ULN
• •Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
• •Non-target vessel or side branch has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to the index procedure
• •Target vessel has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 1 year prior to the index procedure
• •Planned PCI or CABG after the index procedure
• •Subject has a known allergy to contrast that cannot be adequately premedicated or to the study scaffold system or protocol-required concomitant medications (e.g., everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
• •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
• •Subject has a known condition(s) of the following (as assessed prior to the index procedure):
• •* Other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to 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 previously treated at any time with intravascular brachytherapy
• •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 that is clinically significant, including laboratory evidence of active hepatitis
• •Subject is on dialysis or has baseline serum creatinine level \>2.0mg/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., is NYHA class IV) at the time of the index procedure
• •Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint
• •Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure
• •Subject is a woman of child-bearing potential 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)
• •Planned treatment of more than 1 target lesion and 1 non-target lesion (see below "Multiple Interventions During Index Procedure")
• •Planned treatment of the target lesion with more than 1 scaffold
• •Target lesion is located in the left main
• •Target lesion is located within 3mm of the origin of the left anterior descending (LAD) coronary artery, left circumflex (LCX) coronary artery or right coronary artery (RCA)
• •Target lesion is located within a saphenous vein graft or arterial graft or will be accessed via a saphenous vein graft or an arterial graft
• •Target lesion involves a side branch \>2.0mm in diameter
• •Target lesion involves a clinically significant side branch \<2.0 mm in diameter that has a clinically significant stenosis at the ostium.
• •Target lesion and/or target vessel proximal to the target lesion is moderately to severely calcified
• •Excessive tortuosity or extreme angulation proximal to or within the target lesion
• •Target lesion is restenotic from a previous stent implantation
• •Thrombus, or possible thrombus, present in the target vessel
• •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., bifurcation lesion requiring treatment with more than 1 stent)
• •* Restenotic from previous intervention
• •Subject has unprotected left main coronary artery disease (\>50% diameter stenosis)