Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent (MIRAII)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Taewoong Medical Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jong Taek, Lee, Taewoong Medical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01413386
First received: August 9, 2011
Last updated: January 11, 2012
Last verified: January 2012

August 9, 2011
January 11, 2012
September 2011
October 2012   (final data collection date for primary outcome measure)
Accumulative Patency Rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01413386 on ClinicalTrials.gov Archive Site
  • Accumulative Survival Rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Stent migration rate [ 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
 
Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent
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.

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.

Paclitaxel covered metal biliary stent (Niti-S Mira-Cover II Biliary Stent) is non-inferior to common covered metal biliary stent (Niti-S Biliary Stent_ComVi type)in their patency rate and safety at the 6 months after stenting.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy 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 II Biliary Stent
  • Niti-S Biliary Stent_ComVi type
  • Experimental: Paclitaxel Eluting Covered 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.
 
Recruiting
150
December 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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%)

Exclusion Criteria:

  • 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
Both
19 Years to 90 Years
No
Contact: Jong Taek Lee 82-31-904-6153 ext 600 jtlee@stent.net
Korea, Republic of
 
NCT01413386
MIRA-001
No
Jong Taek, Lee, Taewoong Medical Co., Ltd.
Jong Taek, Lee
Not Provided
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
Taewoong Medical Co., Ltd.
January 2012

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