Angioplasty, Transluminal, Percutaneous CoronaryIRIS ORSIRONCT02039739
Orsiro™ Drug Eluting Stent in Routine Clinical Practice
An observational study of Angioplasty, Transluminal, Percutaneous Coronary and Coronary Artery Disease, run by Seung-Jung Park at 18 sites in South Korea.
Trial summary
The purpose of this study is to evaluate effectiveness and safety of Orsiro™ Drug Eluting Stent in Routine Clinical Practice Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Angioplasty, Transluminal, Percutaneous Coronary, Coronary Artery Disease
- What is being tested?
- Orsiro™ Drug Eluting Stent group
- Type of treatment
- Medical device
- How many people
- 1,007 participants
- Where
- 18 sitesSouth Korea
- Study dates
- Jun 2014to Jan 2022
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with Orsiro™ Drug Eluting Stent
Who may be able to join
- Age 20 and more
- Intervention with Orsiro™ Drug Eluting Stent
- Agreed with written informed consent form
Who cannot join
- Intervention with Orsiro™ drug eluting coronary stent and other drug eluting stent at the same time
- Life expectancy of 1year and under
- Cardiac shock
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
South Korea18 sites
Hallym University Sacred Heart Hospital
Anyang
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Dankook University Hospital
Cheonan
Soon Chun Hyang University Hospital Cheonan
Cheonan
Gangwon National Univ. Hospital
Chuncheon
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
Gangneung Asan Hospital
Gangneung
Chonnam National University Hospital
Gwangju
Gachon University Gil Hospital
Incheon
Inje University Pusan Paik Hospital
Pusan
Pusan National University Yangsan Hospital
Pusan
Asan Medical Center
Seoul
Gangnam Severance Hospital
Seoul
Kangdong Sacred Heart Hospital
Seoul
Korea University Guro Hospital
Seoul
Ulsan University Hospital
Ulsan
About this study
Official title: Evaluation of Effectiveness and Safety of Orsiro™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study
The purpose of this study is to evaluate effectiveness and safety of Orsiro™ Drug Eluting Stent in Routine Clinical Practice
- Being tested
- Orsiro™ Drug Eluting Stent group
- Keywords
- Orsiro, Drug Eluting Stent, Routine Clinical Practice, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orsiro™ Drug Eluting Stent groupDevice
| Study group | Role | What they receive |
|---|---|---|
| Orsiro™ Drug Eluting Stent | Not described Receives: Device: Orsiro™ Drug Eluting Stent group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite event rate
Measured: 1YEAR
Secondary outcomes (10)
ALL DEATH
Measured: 5YEAR
CARDIAC DEATH
Measured: 5YEAR
MYOCARDIAL INFARCTION
Measured: 5YEAR
Composite event of death or myocardial infarction
Measured: 5YEAR
Composite event of cardiac death or myocardial infarction
Measured: 5YEAR
Target Vessel revascularization
Measured: 5YEAR
Target Lesion revascularization
Measured: 5YEAR
Stent thrombosis
stent thrombosis as classified by an Academic Research Consortium
Measured: 5YEAR
Stroke
Measured: 5YEAR
Procedural success
defined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization
participants will be followed for the duration of hospital stay, an expected average of 3days.
Measured: 3day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2017
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angioplasty, Transluminal, Percutaneous CoronaryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Biotronik Korea Co., Ltd
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039739
- Sponsor's protocol ID
- AMCCV2014-02
- Acronym
- IRIS ORSIRO
- Status last verified
- Jun 2023
- First submitted
- 16 Jan 2014
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is not a publicly funded trial.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Orsiro™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02039739
- Acronym / sponsor ID
- IRIS ORSIRO / AMCCV2014-02
- Keywords
- Orsiro, Drug Eluting Stent, Routine Clinical Practice, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,007 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea, Biotronik Korea Co., Ltd
- Study start
- Jun 2014 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 20 Jan 2014 (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.
The purpose of this study is to evaluate effectiveness and safety of Orsiro™ Drug Eluting Stent in Routine Clinical Practice
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orsiro™ Drug Eluting Stent | – | Device: Orsiro™ Drug Eluting Stent group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with Orsiro™ Drug Eluting Stent
Key inclusion criteria (3 listed)
- Age 20 and more
- Intervention with Orsiro™ Drug Eluting Stent
- Agreed with written informed consent form
Key exclusion criteria (3 listed)
- Intervention with Orsiro™ drug eluting coronary stent and other drug eluting stent at the same time
- Life expectancy of 1year and under
- Cardiac shock
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 |
|---|---|---|
| Orsiro™ Drug Eluting Stent group | Device | Orsiro™ Drug Eluting Stent |
Primary outcome
Composite event rate
Time frame: 1YEAR
10 secondary outcomes
ALL DEATH
Time frame: 5YEAR
CARDIAC DEATH
Time frame: 5YEAR
MYOCARDIAL INFARCTION
Time frame: 5YEAR
Composite event of death or myocardial infarction
Time frame: 5YEAR
Composite event of cardiac death or myocardial infarction
Time frame: 5YEAR
Target Vessel revascularization
Time frame: 5YEAR
Target Lesion revascularization
Time frame: 5YEAR
Stent thrombosis
Time frame: 5YEAR
Stroke
Time frame: 5YEAR
Procedural success
Time frame: 3day
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 28 Jun 2023.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angioplasty, Transluminal, Percutaneous Coronary and Coronary Artery Disease, run by Seung-Jung Park at 18 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 3 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 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Composite event rate (time frame: 1YEAR). 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 28 Jun 2023.