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
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 106
Study Start Date: February 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Taewoong Medical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01512563     History of Changes
Other Study ID Numbers: MIRA-cover
Study First Received: January 11, 2012
Last Updated: January 15, 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 July 24, 2014