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

Sponsor
Taewoong Medical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01512563
Collaborator
(none)
106
Enrollment
3
Locations
2
Arms
36
Duration (Months)
35.3
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common Covered Metallic Biliary Stent.

Condition or Disease Intervention/Treatment Phase
  • Device: Biliary stent
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
106 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
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)
Study Start Date :
Feb 1, 2007
Actual Primary Completion Date :
Feb 1, 2010
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Paclitaxel ElutingCovered Metal Stent

Device: Biliary stent
palliative treatment for malignant patients
Other Names:
  • Niti-S Mira-Cover Biliary Stent
  • Niti-S Biliary Stent

    		•
    Active Comparator: Covered Metal Stent

    Device: Biliary stent
    palliative treatment for malignant patients
    Other Names:
  • Niti-S Mira-Cover Biliary Stent
  • Niti-S Biliary Stent

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Accumulative Patency Rate [6 month]

    Secondary Outcome Measures

    1. Accumulative Survival Rate [6 months]

    2. Complications [6 months]

    3. Possibility of Other Treatment after Obstruction [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Soon Chun Hyang University Hospital Cheonan Cheonan Korea, Republic of
    2 Catholic University of Daegu School of Medicine Daegu Korea, Republic of
    3 Kangnam Severance Hospital Seoul Korea, Republic of 135-720

    Sponsors and Collaborators

    • Taewoong Medical Co., Ltd.

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Taewoong Medical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01512563
    Other Study ID Numbers:
    • MIRA-cover
    First Posted:
    Jan 19, 2012
    Last Update Posted:
    Mar 11, 2020
    Last Verified:
    Jan 1, 2012
    Keywords provided by Taewoong Medical Co., Ltd.
    paclitaxel
    drug eluting stent
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Mar 11, 2020