This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been terminated.
(Delayed subject enrollment)
Sponsor:
Information provided by (Responsible Party):
Jong Taek, Lee, Taewoong Medical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01413386
First received: August 9, 2011
Last updated: July 23, 2017
Last verified: July 2017
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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:


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

Primary Outcome Measures:
  • Accumulative Patency Rate [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Accumulative Survival Rate [ Time Frame: 6 months ]
  • Stent migration rate [ Time Frame: 6 months ]
  • Possibility of Other Treatment after Obstruction [ Time Frame: 6 months ]

Enrollment: 74
Study Start Date: September 2011
Study Completion Date: April 23, 2013
Primary Completion Date: April 18, 2013 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT01413386

Locations
Korea, Republic of
In Ha University Hospital
Jung-gu, In chun, Korea, Republic of, 400-711
Kangnam Severance Hospital
Kangnam, Seoul, Korea, Republic of, 135-720
Asan Medical Center
Songpa-gu, Seoul, Korea, Republic of, 138-736
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

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: July 23, 2017

Keywords provided by Jong Taek, Lee, 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

ClinicalTrials.gov processed this record on September 21, 2017