WallFlex Biliary Fully Covered (FC) Benign Stricture Study
WallFlex Biliary Fully Covered (FC) Benign Stricture Study
The purpose of this study is to evaluate the safety and performance of the WallFlex® Biliary
 RX Fully Covered Stent as a treatment of biliary obstruction resulting from benign bile duct
 strictures.
Inclusion Criteria:

 -  Age 18 or older

 -  Willing and able to comply with the study procedures and provide written informed
 consent to participate in the study

 -  Chronic pancreatitis or prior liver transplantation or prior other abdominal surgery
 (to include cholecystectomy)

 -  Indicated for ERCP procedure with stent placement for: Symptomatic bile duct stricture
 (i.e. obstructive jaundice, persistent cholestasis, acute cholangitis) confirmed by
 cholangiogram and/or Bile duct stricture confirmed by cholangiogram and/or Exchange of
 prior plastic stent(s) for management of benign stricture

 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