X-MAS Biliary Study With Covered Biliary Stent

Exclusion Criteria

• •1\. Participation in an Investigational Study within 90 days prior to date of subject consent.
• •2\. Perforation of any duct within the biliary tree. 3. Presence of more than one previously implanted plastic stent. 4. Previous plastic stent implantation less than 2 weeks prior to current procedure.
• •5\. Presence of a metal biliary stent. 6. Presence of any esophageal or duodenal stent. 7. Previous Bilroth II or Roux-en-Y gastric resection, a significant duodenal obstruction or any other altered anatomy which could prevent access to ampulla.
• •8\. Subjects for whom endoscopic procedures are contraindicated. 9. Subjects with known sensitivity to any components of the stent or delivery system.
• •10\. Subjects with active hepatitis or other hepatic diseases that may cause jaundice.
• •11\. Subjects with a WHO performance score of 4 - Bedbound (completely disabled, cannot carry on any self-care, totally confined to bed or chair).
• •12\. Subjects known to be pregnant.
• •Cholangiographic exclusion criterion:
• •13\. Strictures that cannot be passed by the guide wire or the delivery system.