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Patency and Safety of the Drug Eluting Covered Biliary Stent Comparing to the Common Covered Biliary Stent (MIRA-cover)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01512563
First Posted: January 19, 2012
Last Update Posted: January 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Taewoong Medical Co., Ltd.
January 11, 2012
January 19, 2012
January 19, 2012
February 2007
February 2010   (Final data collection date for primary outcome measure)
Accumulative Patency Rate [ Time Frame: 6 month ]
Same as current
No Changes Posted
  • Accumulative Survival Rate [ Time Frame: 6 months ]
  • Complications [ Time Frame: 6 months ]
  • Possibility of Other Treatment after Obstruction [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
Patency and Safety of the Drug Eluting Covered Biliary Stent Comparing to the Common Covered Biliary Stent
Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent(Niti-S Mira-Cover Biliary Stent ) to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent)
Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common Covered Metallic Biliary Stent.
Paclitaxel covered metal biliary stent(Mira-Cover Biliary Stent) extents their patency rate comparing to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
  • Biliary Stricture
  • Malignant Neoplasms
Device: Biliary stent
palliative treatment for malignant patients
Other Names:
  • Niti-S Mira-Cover Biliary Stent
  • Niti-S Biliary Stent
  • Experimental: Paclitaxel ElutingCovered Metal Stent
    Intervention: Device: Biliary stent
  • Active Comparator: Covered Metal Stent
    Intervention: Device: Biliary stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient who is inoperable and/or unresectable cases of pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
  • Among patient of a.,Patient who previously had surgical biliary drainage of plastic stent have eligibility

Exclusion Criteria:

  • Patient who have life expectancy under 3 months
  • Patient who have severe metastasis of Liver or whole body
  • Patient who previously had surgical biliary drainage
Sexes Eligible for Study: All
19 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01512563
MIRA-cover
No
Not Provided
Not Provided
Taewoong Medical Co., Ltd.
Taewoong Medical Co., Ltd.
Not Provided
Study Chair: Dong Ki Lee, Ph.D Kangnam Severance Hospital
Principal Investigator: Ho Gak Kim Catholic University of Daegu School of Medicine
Principal Investigator: Sang Heum Park Soon Chun Hyang University
Taewoong Medical Co., Ltd.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP