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

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.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01413386

Acronym

MIRAII

Enrollment

Registered

2011-08-10

Start date

2011-09-30

Completion date

2013-04-23

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 is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.

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.

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 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

Design outcomes

Primary

Measure	Time frame
Accumulative Patency Rate	6 months

Secondary

Measure	Time frame
Accumulative Survival Rate	6 months
Stent migration rate	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