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

This study is currently recruiting participants.
Verified January 2012 by Taewoong Medical Co., Ltd.
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Biliary Stricture
Malignant Neoplasms
 Device: biliary stent
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by Taewoong Medical Co., Ltd.:

Primary Outcome Measures:
  • Accumulative Patency Rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel Eluting Covered Metal Stent Device: biliary stent
palliative treatment for malignant patients
Other Names:
  • Niti-S Mira-Cover II Biliary Stent
  • Niti-S Biliary Stent_ComVi type
Active Comparator: Covered Metal Stent Device: biliary stent
palliative treatment for malignant patients
Other Names:
  • Niti-S Mira-Cover II Biliary Stent
  • Niti-S Biliary Stent_ComVi type

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413386

Contacts
Contact: Jong Taek Lee 82-31-904-6153 ext 600 jtlee@stent.net

Locations
Korea, Republic of
In Ha University Hospital Recruiting
Jung-gu, In chun, Korea, Republic of, 400-711
Contact: Don Haeng Lee, Ph.D     +82-32-890-2548     idh@inha.ac.kr    
Contact: Jung Seuk, Ph.D     +82-32-890-2548        
Principal Investigator: Don Heang Lee, Ph.D            
Sub-Investigator: Jung Seuk, Ph.D            
Kangnam Severance Hospital Recruiting
Kangnam, Seoul, Korea, Republic of, 135-720
Contact: Dong Ki Lee, Ph.D     82-2-2019-2330     dklee@yuhs.ac    
Contact: Sung Il Jang     82-2-2019-2331     aerojsi@yuhs.ac    
Principal Investigator: Dong Ki Lee, Ph.D            
Sub-Investigator: Sung Il Jang            
Asan Medical Center Recruiting
Songpa-gu, Seoul, Korea, Republic of, 138-736
Contact: Mung Whan Kim, Ph.D     82-2-3010-3183     mhkim@amc.seoul.kr    
Contact: Sung Gu Lee, Ph.D     82-2-3010-3186        
Principal Investigator: Mung Whan Kim, Ph.D            
Sub-Investigator: Sung Gu Lee, Ph.D            
Sponsors and Collaborators
Jong Taek, Lee
Investigators
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
  More Information

No publications provided

Responsible Party: Jong Taek, Lee, Taewoong Medical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01413386     History of Changes
Other Study ID Numbers: MIRA-001
Study First Received: August 9, 2011
Last Updated: January 11, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Taewoong Medical Co., Ltd.:
paclitaxel
drug eluting stent

Additional relevant MeSH terms:
Neoplasms
Cholestasis
Constriction, Pathologic
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Paclitaxel
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013