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OpenTrials
Completed

NCT Number: NCT01512563

Patency and Safety of the Drug Eluting Covered Biliary Stent Comparing to the Common Covered Biliary Stent

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

Completed

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Key information

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soon Chun Hyang University Hospital Cheonan, Cheonan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biliary stent

Device

palliative treatment for malignant patients

Other names: Niti-S Mira-Cover Biliary Stent, Niti-S Biliary Stent

Primary outcomes

  1. Accumulative Patency Rate

    Time frame: 6 month

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Taewoong Medical Co., Ltd.

Industry

Registry information

Official study 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)

Acronym: MIRA-cover

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jan 19, 2012
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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