Biliary StrictureMIRA-coverNCT01512563
Patency and Safety of the Drug Eluting Covered Biliary Stent Comparing to the Common Covered Biliary Stent
A study testing Biliary stent in people with Biliary Stricture and Malignant Neoplasms, run by Taewoong Medical Co., Ltd. at 3 sites in South Korea.
Trial summary
Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common Covered Metallic Biliary Stent. 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
- 106 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Feb 2007to Feb 2010
- 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 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Soon Chun Hyang University Hospital Cheonan
Cheonan
Catholic University of Daegu School of Medicine
Daegu
Kangnam Severance Hospital
Seoul, 135-720
About this study
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)
Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common Covered Metallic Biliary Stent.
Read the 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.
- 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 Biliary Stent, Niti-S Biliary Stent
palliative treatment for malignant patients
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel ElutingCovered 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 month
Secondary outcomes (3)
Accumulative Survival Rate
Measured: 6 months
Complications
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.
- First posted19 Jan 2012 (estimated)
- Study startFeb 2007
- Primary completionFeb 2010
- Study completionFeb 2010
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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taewoong Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Ki Lee, Ph.D, Study chair, Kangnam Severance HospitalHo Gak Kim, Principal investigator, Catholic University of Daegu School of MedicineSang Heum Park, Principal investigator, Soon Chun Hyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512563
- Sponsor's protocol ID
- MIRA-cover
- Acronym
- MIRA-cover
- Status last verified
- Jan 2012
- First submitted
- 11 Jan 2012
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
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
- 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)
- ClinicalTrials.gov ID
- NCT01512563
- Acronym / sponsor ID
- MIRA-cover / MIRA-cover
- Conditions
- Biliary Stricture, Malignant Neoplasms
- Keywords
- paclitaxel, drug eluting stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Taewoong Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 Jan 2012 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel ElutingCovered 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 (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 Biliary Stent, Niti-S Biliary Stentpalliative treatment for malignant patients | Device | Covered Metal Stent, Paclitaxel ElutingCovered Metal Stent |
Primary outcome
Accumulative Patency Rate
Time frame: 6 month
3 secondary outcomes
Accumulative Survival Rate
Time frame: 6 months
Complications
Time frame: 6 months
Possibility of Other Treatment after Obstruction
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
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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
Ho Gak Kim principal investigator
Catholic University of Daegu School of Medicine
Sang Heum Park principal investigator
Soon Chun Hyang University
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 Taewoong Medical Co., Ltd. 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 2 inclusion and 3 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.