WallFlex Biliary Fully Covered (FC) Benign Stricture Study

Boston Scientific

Status and phase: Completed; Phase 3

Conditions: Biliary Stricture

Treatments: Device: WallFlex Biliary RX Fully Covered Stent System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01014390

CDM 00027550

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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187 participants in 1 patient group

WallFlex Biliary RX FC Stent System

Experimental group

Description:

The WallFlex Biliary RX Fully Covered Stent System is being evaluated for treatment of benign biliary strictures.

Treatment:

Device: WallFlex Biliary RX Fully Covered Stent System