Coronary Artery DiseaseIRIS SierraNCT03967158
Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice
An observational study of Coronary Artery Disease and Coronary Disease, run by Seung-Jung Park at 10 sites in South Korea.
Trial summary
The objective of this study is to evaluate effectiveness and safety of Xience Sierra stent in the "real world" daily practice as compared with other drug-eluting stents. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease
- What is being tested?
- Xience Sierra stent
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 23 Dec 2019to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Xience Sierra coronary stent
Who may be able to join
- Age 19 and more
- Patient with Xience Sierra Everolimus eluting coronary stent
- Written consent
Who cannot join
- Intervention with Xience Sierra Everolimus eluting coronary stent and other drug eluting stent at the same time
- Life-expectancy less than 1 year
- Cardiac shock
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Dong-A Medical Center
Busan
Inje University Busan Paik Hospital
Busan
Gangwon National Univ. Hospital
Chuncheon
Keimyung University Dongsan Medical Center
Daegu
Gangneung Asan Hospital
Gangneung
Asan Medical Center
Seoul
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul
St.carollo Hospital
Suncheon
Wonju Severance Christian Hospital
Wŏnju
About this study
Official title: Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice; A MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY
The objective of this study is to evaluate effectiveness and safety of Xience Sierra stent in the "real world" daily practice as compared with other drug-eluting stents.
- Conditions
- Coronary Artery Disease, Coronary Disease
- Being tested
- Xience Sierra stent
- Keywords
- Xience Sierra, Drug Eluting Stent, Percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xience Sierra stentDevice
Percutaneous coronary intervention with Xience Sierra stent
| Study group | Role | What they receive |
|---|---|---|
| Consecutive percutaneous coronary intervention | Not described Receives: Device: Xience Sierra stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
Measured: 1 year
Secondary outcomes (10)
All cause death
Measured: 5 year
Cardiac death
Measured: 5 year
Myocardial Infarction
Measured: 5 year
Composite event rate of death or myocardial infarction (MI)
Measured: 5 year
Composite event rate of cardiac death or myocardial infarction (MI)
Measured: 5 year
Target- Vessel Revascularization
Measured: 5 year
Target- Lesion Revascularization
Measured: 5 year
Stent thrombosis
Measured: 5 year
Stroke
Measured: 5 year
Procedural Success rate
Procedural success rate is defined as < 30 % final stenosis and the absence of in-hospital event including death, myocardial infarction, repeat revascularization.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start23 Dec 2019
- Primary completion27 Aug 2024
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967158
- Sponsor's protocol ID
- AMCCV2019-03
- Acronym
- IRIS Sierra
- Status last verified
- Dec 2025
- First submitted
- 27 May 2019
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice; A MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY
- ClinicalTrials.gov ID
- NCT03967158
- Acronym / sponsor ID
- IRIS Sierra / AMCCV2019-03
- Conditions
- Coronary Artery Disease, Coronary Disease
- Keywords
- Xience Sierra, Drug Eluting Stent, Percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 May 2019 (actual)
- 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 objective of this study is to evaluate effectiveness and safety of Xience Sierra stent in the "real world" daily practice as compared with other drug-eluting stents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consecutive percutaneous coronary intervention | – | Device: Xience Sierra stent |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Xience Sierra coronary stent
Key inclusion criteria (3 listed)
- Age 19 and more
- Patient with Xience Sierra Everolimus eluting coronary stent
- Written consent
Key exclusion criteria (3 listed)
- Intervention with Xience Sierra Everolimus eluting coronary stent and other drug eluting stent at the same time
- Life-expectancy less than 1 year
- 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 |
|---|---|---|
| Xience Sierra stentPercutaneous coronary intervention with Xience Sierra stent | Device | Consecutive percutaneous coronary intervention |
Primary outcome
Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR)
Time frame: 1 year
10 secondary outcomes
All cause death
Time frame: 5 year
Cardiac death
Time frame: 5 year
Myocardial Infarction
Time frame: 5 year
Composite event rate of death or myocardial infarction (MI)
Time frame: 5 year
Composite event rate of cardiac death or myocardial infarction (MI)
Time frame: 5 year
Target- Vessel Revascularization
Time frame: 5 year
Target- Lesion Revascularization
Time frame: 5 year
Stent thrombosis
Time frame: 5 year
Stroke
Time frame: 5 year
Procedural Success rate
Time frame: 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Disease, run by Seung-Jung Park at 10 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: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
This study is still under way. Results are not available in the source record yet.
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 of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) (time frame: 1 year). 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 2 Jan 2026.