Study Stopped
Delayed subject enrollment
Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent
MIRAII
A Randomized Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent (Niti-S Mira-Cover II Biliary Stent) to the Common Covered Metallic Biliary Stent.
1 other identifier
interventional
74
1 country
3
Brief Summary
Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2011
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2011
CompletedFirst Posted
Study publicly available on registry
August 10, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2013
CompletedMarch 11, 2020
March 1, 2020
1.6 years
August 9, 2011
March 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Accumulative Patency Rate
6 months
Secondary Outcomes (3)
Accumulative Survival Rate
6 months
Stent migration rate
6 months
Possibility of Other Treatment after Obstruction
6 months
Study Arms (2)
Paclitaxel Eluting Covered Metal Stent
EXPERIMENTALCovered Metal Stent
ACTIVE COMPARATORInterventions
palliative treatment for malignant patients
Eligibility Criteria
You may qualify if:
- Patient who submitted a written informed consent for the this trial, and 18 \~ 90 years old
- Patient who have pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
- Patient who is inoperable and/or unresectable cases of malignant pancreatic stenosis
- Patient who is attempting of endoscopic biliary metallic stenting (by ERBD) firstly
- Patient who have life expectancy at least longer than 3 months (Karnofsky score \>60%)
You may not qualify if:
- Patient who previously had surgical biliary drainage
- Patient who carrying bleeding disorder
- Patient who have combined Hilar and/or intra-hepatic duct cancer
- Patient who is improper to endoscopic treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jong Taek, Leelead
Study Sites (3)
In Ha University Hospital
Incheon, In Chun, 400-711, South Korea
Kangnam Severance Hospital
Kangnam, Seoul, 135-720, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Dong Ki Lee, Ph.D
Kangnam Severance Hospital
- PRINCIPAL INVESTIGATOR
Mung Whan Kim, Ph.D
Asan Medical Center
- PRINCIPAL INVESTIGATOR
Don Haeng Lee, Ph.D
Inha University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Taewoong Medical Co., Ltd.
Study Record Dates
First Submitted
August 9, 2011
First Posted
August 10, 2011
Study Start
September 1, 2011
Primary Completion
April 18, 2013
Study Completion
April 23, 2013
Last Updated
March 11, 2020
Record last verified: 2020-03