Biliary StrictureMIRAIINCT01413386

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

A study testing biliary stent in people with Biliary Stricture and Malignant Neoplasms, run by Jong Taek, Lee at 3 sites in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 19 to 90 years
Conditions the study is for: Biliary Stricture, Malignant Neoplasms
What is being tested?: biliary stent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 3 sitesSouth Korea
Study dates: Sep 2011to 23 Apr 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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%)

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

In Ha University Hospital
Incheon, In Chun, 400-711
Kangnam Severance Hospital
Kangnam, Seoul, 135-720
Asan Medical Center
Seoul, 138-736

Other trials in South Korea

About this study

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.

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.

Read the 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.

Conditions: Biliary Stricture, Malignant Neoplasms
Being tested: biliary stent
Keywords: paclitaxel, drug eluting stent
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

biliary stentDevice
Also called Niti-S Mira-Cover II Biliary Stent, Niti-S Biliary Stent_ComVi type
palliative treatment for malignant patients

Study groups in NCT01413386
Study group	Role	What they receive
Paclitaxel Eluting Covered Metal Stent	Experimental	Not described Receives: Device: biliary stent
Covered Metal Stent	Active comparator	Not described Receives: Device: biliary stent

What is being measured

The primary outcome is the main question the study is designed to answer.

Accumulative Patency Rate
Measured: 6 months

Secondary outcomes (3)

Accumulative Survival Rate
Measured: 6 months
Stent migration rate
Measured: 6 months
Possibility of Other Treatment after Obstruction
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201123 Apr 2013

First posted10 Aug 2011 (estimated)
Study startSep 2011
Primary completion18 Apr 2013
Study completion23 Apr 2013

Why it stopped: Delayed subject enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Biliary StrictureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01413386
Sponsor's protocol ID: MIRA-001
Acronym: MIRAII
Status last verified: Mar 2020
First submitted: 9 Aug 2011
Last updated: 11 Mar 2020
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial
Malignant Biliary Obstruction, Malignant Biliary Stricture
Not yet recruiting
The HANAROSTENT® Multi-Hole™ Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole™ Stent for the Palliative Treatment of Malignant Biliary Obstruction.
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UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures
Biliary Obstruction, Bile Duct Stricture

All Biliary Stricture trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01413386
Acronym / sponsor ID: MIRAII / MIRA-001
Conditions: Biliary Stricture, Malignant Neoplasms
Keywords: paclitaxel, drug eluting stent
Study type: Interventional
Recruitment status: TerminatedReason stopped: Delayed subject enrollment
Enrolment: 74 participants (actual)
Lead sponsor: Jong Taek, LeeIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: 18 Apr 2013 (actual)
Study completion: 23 Apr 2013 (actual)
First posted: 10 Aug 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Paclitaxel Eluting Covered Metal Stent	Experimental	Device: biliary stent
Covered Metal Stent	Active comparator	Device: biliary stent

Who may qualify

Ages: 19 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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%)

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
biliary stentAlso: Niti-S Mira-Cover II Biliary Stent, Niti-S Biliary Stent_ComVi typepalliative treatment for malignant patients	Device	Covered Metal Stent, Paclitaxel Eluting Covered Metal Stent

Primary outcome

Accumulative Patency Rate
Time frame: 6 months

3 secondary outcomes

Accumulative Survival Rate
Time frame: 6 months
Stent migration rate
Time frame: 6 months
Possibility of Other Treatment after Obstruction
Time frame: 6 months

Results and safety

The study was stopped early (reason given: Delayed subject enrollment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.

Related trials for Biliary Stricture

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial
Malignant Biliary Obstruction, Malignant Biliary Stricture
Not yet recruiting
The HANAROSTENT® Multi-Hole™ Biliary Stent is Indicated for Use in the Palliative Treatment of Biliary Strictures Produced by Malignant Neoplasms and the Study is to Demonstrate Clinical Safety and Performance of the Multi-Hole™ Stent for the Palliative Treatment of Malignant Biliary Obstruction.
Biliary Strictures Caused by Malignant Neoplasms
RecruitingPhase 2
Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation
Primary Sclerosing Cholangitis, Liver Transplant, Complications
Recruiting
UNITY-B A Prospective, Multicentric, Single-arm Study to Evaluate the Safety and Efficacy of the UNITY-B Biodegradable Balloon-Expandable Biliary Stent System in Subjects With Biliary Strictures
Biliary Obstruction, Bile Duct Stricture

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dong Ki Lee, Ph.D study chair

Kangnam Severance Hospital

Mung Whan Kim, Ph.D principal investigator

Asan Medical Center

Don Haeng Lee, Ph.D principal investigator

Inha University Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing biliary stent in people with Biliary Stricture and Malignant Neoplasms, run by Jong Taek, Lee at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Delayed subject enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accumulative Patency Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01413386.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.