Prevail Global Study

Prior treatment

• Previous PCI of the target vessel within 6 months prior to the procedure
• Planned surgery that would cause interruption in recommended DAPT duration per current guidelines
• Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires additional coronary angiography, IVUS or other coronary artery imaging procedures

Other illness

• Known hypersensitivity or contraindication to antiplatelet medications or a sensitivity to contrast media which cannot be adequately pre-medicated
• History of an allergic reaction or significant sensitivity to paclitaxel or any other analogue or derivative
• Renal insufficiency (or failure)
• History of a stroke or transient ischemic attack (TIA)
• Active peptic ulcer or upper gastrointestinal (GI) bleeding
• History of bleeding diathesis or coagulopathy or will refuse blood transfusions

Lab values

• Platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a white blood cell (WBC) count \< 3,000 cells/mm³
• Documented left ventricular ejection fraction (LVEF) \<30%

Other

• Acute MI
• Planned PCI of any vessel within 72 hours post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure

• ≥ 18 years
• Negative pregnancy test
• Stable or unstable angina, positive functional test, or stable NSTEMI
• Life expectancy \>1 year
• Willing and able to cooperate with study procedures and required follow up evaluations