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:
Information provided by (Responsible Party):
Taewoong Medical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01512563
First received: January 11, 2012
Last updated: January 15, 2012
Last verified: January 2012

January 11, 2012
January 15, 2012
February 2007
February 2010   (final data collection date for primary outcome measure)
Accumulative Patency Rate [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01512563 on ClinicalTrials.gov Archive Site
  • Accumulative Survival Rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Complications [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Possibility of Other Treatment after Obstruction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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
Both
19 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01512563
MIRA-cover
No
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