Evolution® Biliary Stent System-Fully Covered

Inclusion Criteria: * Inoperable malignant neoplasm causing biliary obstruction or stricture that requires a fully covered metal stent Exclusion Criteria: * \< 18 years of age * Unwilling or unable to sign and date the informed consent * Unwilling or unable to comply with the follow-up schedule * Undergone or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources * Participating in another investigational drug or device study in which patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment * Endoscopic procedures are contraindicated * Current anatomy upstream of intended stent placement compromising the flow of bile from the liver such that stent placement may not alleviate the biliary obstruction symptoms * Presence of a metal biliary stent * Presence of an esophageal or duodenal stent * Hypersensitivity/allergy or contraindication to any component of the stent, delivery system, or medication required to complete the procedure,which in the investigator's opinion cannot be adequately premedicated * Coagulopathy * Diffuse intrahepatic metastases that involves \> 10 % of the liver * Life expectancy of \< 3 months * Pregnant * Active alcohol or substance abuse issue * Jaundice secondary to a cause other than biliary duct obstruction * Additional endoscopic restrictions as specified in the Clinical Investigation Plan