Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry

Completed

• Conditions: Biliary Strictures
• Interventions: Device: WallFlex™ Biliary RX Fully Covered Stent System RMV; Device: WallFlex™ Biliary RX Partially Covered Stent System; Device: WallFlex™ Biliary RX Uncovered Stent System

• Registration Number: NCT02261623
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

The purpose of this study is to document stent functionality and practice patterns in Canada pertaining to indications for use and stent type selection for self-expanding biliary metal stents (SEMS) when used per standard of practice.

Detailed Description

This study is designed to provide a report of these features related to the use of WallFlex metal biliary stents used per standard of practice in Canada.

Study Timeline

• Study First Submitted: 2014-10-07
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-10
• Study Start: 2015-03-19
• Primary Completion: 2016-03-31
• Study Completion: 2016-03-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-03
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 415

Inclusion Criteria

• Subject indicated for biliary metal stent placement per local standard of practice
• Age 18 or older
• Willing and able to comply with study procedures and follow-up schedule
• Willing and able to provide written informed consent to participate in study

Exclusion Criteria

• Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
• Subjects who the investigator deems at risk for device or procedure related complications per the Directions for Use (DFU)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Benign biliary strictures	WallFlex™ Biliary RX Fully Covered Stent System RMV	Treatment of benign biliary strictures
Palliation	WallFlex™ Biliary RX Uncovered Stent System	Palliative treatment of biliary strictures produced by malignant neoplasms, no intended surgery
Benign biliary strictures	WallFlex™ Biliary RX Uncovered Stent System	Treatment of benign biliary strictures
Palliation	WallFlex™ Biliary RX Partially Covered Stent System	Palliative treatment of biliary strictures produced by malignant neoplasms, no intended surgery
Curative intent surgery	WallFlex™ Biliary RX Partially Covered Stent System	Palliative treatment of biliary strictures produced by malignant neoplasms, prior to curative intent surgery, with or without neoadjuvant therapy
Curative intent surgery	WallFlex™ Biliary RX Uncovered Stent System	Palliative treatment of biliary strictures produced by malignant neoplasms, prior to curative intent surgery, with or without neoadjuvant therapy
Palliation	WallFlex™ Biliary RX Fully Covered Stent System RMV	Palliative treatment of biliary strictures produced by malignant neoplasms, no intended surgery
Other indication	WallFlex™ Biliary RX Partially Covered Stent System	Other indication
Other indication	WallFlex™ Biliary RX Uncovered Stent System	Other indication
Benign biliary strictures	WallFlex™ Biliary RX Partially Covered Stent System	Treatment of benign biliary strictures

Primary Outcome Measures

Name	Time	Method
Stent Functionality	24 Months	Stent functionality defined as absence of unscheduled biliary reintervention for the management of biliary obstructive symptoms during study stent indwell

Secondary Outcome Measures

Name	Time	Method
Technical success at removal	24 Months	Technical success at removal (as applicable) defined as ability to remove the stent endoscopically without serious adverse device removal related event
Time to recurrence of original stricture	24 Months	Time to recurrence of original stricture
Serious adverse events	24 Months	Occurrence of serious adverse events related to the stent and/or the stent placement and/or stent removal procedures as applicable
Indication for stent placement	12 Months	Distribution of indications for stent placement
Resolution of the indication for stent placement	24 Months	Resolution of the indication for stent placement
Stent types	12 Months	Distribution of stent types by indication for stent placement
Biliary obstructive symptoms	24 Months	Biliary Obstructive Symptom assessment at all biliary reinterventions compared to baseline
Stricture resolution	24 Months	Stricture resolution defined as absence of a stricture requiring drainage (restenting) at time of stent removal
Technical success at placement	24 Months	Technical success at placement defined as ability to deploy the stent in a satisfactory position
Neoadjuvant therapy	24 Months	Ability to complete the planned neoadjuvant therapy regimen without interruptions

Trial Locations

Locations (12)

Peter Lougheed Centre; 🇨🇦 Calgary, Alberta, Canada

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

CHUM - Hopital Saint-Luc; 🇨🇦 Montreal, Quebec, Canada

Providence Health - St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Hopital Charles Le Moyne; 🇨🇦 Greenfield Park, Quebec, Canada

Queen Elizabeth II Health Sciences Center; 🇨🇦 Halifax, Nova Scotia, Canada

Oakville-Trafalgar Memorial Hospital; 🇨🇦 Oakville, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Victoria General Hospital; 🇨🇦 Victoria, British Columbia, Canada

CHUS Hotel Dieu; 🇨🇦 Sherbrooke, Quebec, Canada