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

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01512563

Acronym

MIRA-cover

Enrollment

106

Registered

2012-01-19

Start date

2007-02-28

Completion date

2010-02-28

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Stricture, Malignant Neoplasms

Keywords

paclitaxel, drug eluting stent

Brief summary

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

Interventions

DEVICEBiliary stent

palliative treatment for malignant patients

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Accumulative Patency Rate	6 month

Secondary

Measure	Time frame
Accumulative Survival Rate	6 months
Complications	6 months
Possibility of Other Treatment after Obstruction	6 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026