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

Biliary Stricture Clinical Trial

— MIRAII  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01413386
• Other study ID #: MIRA-001
• Status: Terminated
• Phase: N/A
• Start date: September 2011
• Est. completion date: April 23, 2013

Study information

• Verified date: March 2020
• Source: Taewoong Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 74
• Est. completion date: April 23, 2013
• Est. primary completion date: April 18, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

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	In Ha University Hospital	Incheon	In Chun
Korea, Republic of	Kangnam Severance Hospital	Kangnam	Seoul
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jong Taek, Lee

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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