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

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ClinicalTrials.gov Identifier: NCT01512563
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
Taewoong Medical Co., Ltd.

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
Biliary Stricture Malignant Neoplasms Device: Biliary stent Phase 3

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 Type : Interventional  (Clinical Trial)
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 : February 2007
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Accumulative Patency Rate [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Accumulative Survival Rate [ Time Frame: 6 months ]
  2. Complications [ Time Frame: 6 months ]
  3. Possibility of Other Treatment after Obstruction [ Time Frame: 6 months ]


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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512563


Locations
Korea, Republic of
Kangnam Severance Hospital
Kangnam, Seoul, Korea, Republic of, 135-720
Soon Chun Hyang University Hospital Cheonan
Cheonan, Korea, Republic of
Catholic University of Daegu School of Medicine
Daegu, Korea, Republic of
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

Responsible Party: Taewoong Medical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01512563     History of Changes
Other Study ID Numbers: MIRA-cover
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012

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

Additional relevant MeSH terms:
Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action