Evolution® Biliary Stent System-Fully Covered

Not Applicable

Completed

Brief Summary: The Evolution® Biliary Stent System-Fully Covered study is a clinical trial approved by the US FDA to evaluate the effectiveness of the Evolution® Biliary Stent System-Fully Covered when used in palliation of malignant neoplasms in the biliary tree.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Evolution® Biliary Stent-Fully Covered	Evolution® Biliary Stent-Fully Covered	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients free from symptomatic recurrent of biliary obstruction requiring reintervention	6 months
Total Serum Bilirubin ≤ 3.0 mg/dL	1 month

Secondary Outcome Measures

Name	Time	Method

Locations (12): University of Colorado Hospital
🇺🇸
Aurora, Colorado, United States
Hôpital Edouard Herriot
🇫🇷
Lyon Cedex 03, France
Wake Forest Baptist Medical Center
🇺🇸
Winston-Salem, North Carolina, United States
Indiana University Hospital
🇺🇸
Indianapolis, Indiana, United States
Moffitt Cancer Center
🇺🇸
Tampa, Florida, United States
St. Michael's Hospital
🇨🇦
Toronto, Ontario, Canada
Borland-Groover Clinic
🇺🇸
Jacksonville, Florida, United States
University of Virginia Health System
🇺🇸
Charlottesville, Virginia, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Hôpital L'Archet 2
🇫🇷
Nice Cedex 03, France
Centre Hospitalier de 1'Université
🇨🇦
Montréal, Quebec, Canada
Erasmus Medish Centrum
🇳🇱
Rotterdam, Netherlands