WallFlex Biliary Fully Covered (FC) Benign Stricture Study

Exclusion Criteria

• •General:
• •Placement of the stent in strictures that cannot be dilated enough to pass the delivery system
• •Placement of the stent in a perforated duct
• •Placement of the stent in very small intrahepatic ducts
• •Patients for whom endoscopic techniques are contraindicated
• •Biliary stricture of malignant etiology
• •Biliary stricture of benign etiology other than chronic pancreatitis or liver transplant anastomosis or other abdominal surgery
• •Stricture within 2 cm of duct bifurcation
• •Symptomatic duodenal stenosis (with gastric stasis)
• •Prior biliary self-expanding metal stent
• •Suspected stricture ischemia based on imaging of hepatic artery occlusion or endoscopic evidence of biliary cast syndrome
• •Known bile duct fistula
• •Known sensitivity to any components of the stent or delivery system
• •Participation in another investigational study within 90 days prior to consent or during the study
• •Additional Specific to Chronic Pancreatitis Patients:
• •Developing obstructive biliary symptoms associated with an attack of acute pancreatitis
• •Additional Specific to Post-Abdominal Surgery Patients:
• •History of hepatectomy
• •History of liver transplant
• •Additional Specific to Liver Transplant Patients:
• •Live donor transplantation