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

Biliary Stricture Clinical Trial

— MIRA-cover  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512563
• Other study ID #: MIRA-cover
• Status: Completed
• Phase: N/A
• Start date: February 2007
• Est. completion date: February 2010

Study information

• Verified date: January 2012
• Source: Taewoong Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Stricture
• Constriction, Pathologic
• Malignant Neoplasms
• Neoplasms

Intervention

Device:
• Biliary stent
palliative treatment for malignant patients

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital Cheonan	Cheonan
Korea, Republic of	Catholic University of Daegu School of Medicine	Daegu
Korea, Republic of	Kangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Taewoong Medical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accumulative Patency Rate		6 month
Secondary	Accumulative Survival Rate		6 months
Secondary	Complications		6 months
Secondary	Possibility of Other Treatment after Obstruction		6 months