Evolution® Biliary Stent System-Fully Covered

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02104076

Enrollment

Registered

2014-04-04

Start date

2014-09-30

Completion date

2017-01-04

Last updated

2017-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinomas/Neoplasms

Keywords

Bile Duct Obstructions, Biliary Stases, Biliary Tract, Stents

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.

Interventions

DEVICEEvolution® Biliary Stent-Fully Covered

Implantation of the Evolution® Biliary Stent-Fully Covered in the common bile duct utilizing ERCP

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Countries

Canada, France, Netherlands, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026