Coronary Artery DiseaseIRIS SkypointNCT05981911
Evaluation of Effectiveness and Safety of Xience Skypoint Stents in Routine Clinical Practice
An observational study of Coronary Artery Disease, run by Seung-Jung Park at 1 site in South Korea.
Trial summary
The objective of this study is to evaluate the effectiveness and safety of XIENCE Skypoint stents in comparison to other drug-eluting stents (DES) in real-world practice. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- XIENCE Skypoint™ stent
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Dec 2023to Dec 2026
- 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: Patients receiving Xience-Skypoint™ stents.
Who may be able to join
- Patients ≥ 19 years old
- Patients receiving Xience-Skypoint™ stents.
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
Who cannot join
- Patients with a mixture of other DESs
- Terminal illness with life expectancy <1 year
- Patients with cardiogenic shock
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Hospital
Seoul
Seung-jung Park, MD, sjpark@amc.seoul.kr
Seung-jung Park, MD
About this study
Official title: a Non-randomized, Prospective, Open-label Registry to Compare the Effectiveness and Safety of XIENCE Skypoint™ Stents Versus Other DESs in Patients With Coronary Artery Disease
The objective of this study is to evaluate the effectiveness and safety of XIENCE Skypoint stents in comparison to other drug-eluting stents (DES) in real-world practice.
- Conditions
- Coronary Artery Disease
- Being tested
- XIENCE Skypoint™ stent
- Keywords
- drug eluting stent, Percutaneous Coronary Intervention
- 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.
XIENCE Skypoint™ stentDevice
Percutaneous coronary intervention with Xience-Skypoint™ stent
| Study group | Role | What they receive |
|---|---|---|
| XIENCE Skypoint™ stent | Patients receiving Xience-Skypoint™ stents Receives: Device: XIENCE Skypoint™ stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
the composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post procedure.
A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.
Measured: 12 months
Secondary outcomes (10)
the event rate of all cause death
Measured: 5 years
the event rate of cardiac death
Measured: 5 years
the event rate of nonfatal myocardial infarction
Measured: 5 years
the composite event rate of death, or nonfatal myocardial infarction (MI)
Measured: 5 years
the composite event rate of cardiac death, or nonfatal myocardial infarction (MI)
Measured: 5 years
the event rate of Target- Vessel Revascularization (TVR)
Measured: 5 years
the event rate of Target- lesion Revascularization (TLR)
Measured: 5 years
the event rate of stent thrombosis
according to an Academic Research Consortium (ARC) criteria
Measured: 5 years
the event rate of stroke
Measured: 5 years
the event rate of Procedural success
(defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start14 Dec 2023
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (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 (estimated)
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
- NCT05981911
- Sponsor's protocol ID
- AMCCV2023-04
- Acronym
- IRIS Skypoint
- Status last verified
- Dec 2025
- First submitted
- 1 Aug 2023
- 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
- a Non-randomized, Prospective, Open-label Registry to Compare the Effectiveness and Safety of XIENCE Skypoint™ Stents Versus Other DESs in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05981911
- Acronym / sponsor ID
- IRIS Skypoint / AMCCV2023-04
- Conditions
- Coronary Artery Disease
- Keywords
- drug eluting stent, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Aug 2023 (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 the effectiveness and safety of XIENCE Skypoint stents in comparison to other drug-eluting stents (DES) in real-world practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XIENCE Skypoint™ stent | – | Device: XIENCE Skypoint™ stentPatients receiving Xience-Skypoint™ stents |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving Xience-Skypoint™ stents.
Key inclusion criteria (3 listed)
- Patients ≥ 19 years old
- Patients receiving Xience-Skypoint™ stents.
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
Key exclusion criteria (3 listed)
- Patients with a mixture of other DESs
- Terminal illness with life expectancy <1 year
- Patients with cardiogenic 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 Skypoint™ stentPercutaneous coronary intervention with Xience-Skypoint™ stent | Device | XIENCE Skypoint™ stent |
Primary outcome
the composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Time frame: 12 months
the composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post procedure. A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.
10 secondary outcomes
the event rate of all cause death
Time frame: 5 years
the event rate of cardiac death
Time frame: 5 years
the event rate of nonfatal myocardial infarction
Time frame: 5 years
the composite event rate of death, or nonfatal myocardial infarction (MI)
Time frame: 5 years
the composite event rate of cardiac death, or nonfatal myocardial infarction (MI)
Time frame: 5 years
the event rate of Target- Vessel Revascularization (TVR)
Time frame: 5 years
the event rate of Target- lesion Revascularization (TLR)
Time frame: 5 years
the event rate of stent thrombosis
Time frame: 5 years
the event rate of stroke
Time frame: 5 years
the event rate of Procedural success
Time frame: 7 days
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.
1 site 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, run by Seung-Jung Park at 1 site 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: looking for participants now, 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 1 site 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?
Contact Jung-hee Ham, Project manager (82230104728, cvcrc5@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the composite event rate of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) (time frame: 12 months). 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.