Evolution® Biliary Stent System-Fully Covered

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation for the Effectiveness of Evolution® Biliary Stent System-Fully Covered

Conditions
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Carcinomas/Neoplasms

Intervention / Treatment
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* Device: Evolution® Biliary Stent-Fully Covered


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evolution® Biliary Stent-Fully Covered<br> | Device: Evolution® Biliary Stent-Fully Covered<br>* Implantation of the Evolution® Biliary Stent-Fully Covered in the common bile duct utilizing ERCP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients free from symptomatic recurrent of biliary obstruction requiring reintervention |  | 6 months | 
| Total Serum Bilirubin ≤ 3.0 mg/dL |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bile Duct Obstructions, Biliary Stases, Biliary Tract, Stents