Coronary StenosisIRIS DESyne X2NCT03588481
IRIS- DESyne X2 in the IRIS-DES Registry
An observational study of Coronary Stenosis and Coronary Occlusion, run by Seung-Jung Park at 6 sites in South Korea.
Trial summary
This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Stenosis, Coronary Occlusion, Coronary Disease
- What is being tested?
- DESyne X2
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 28 Nov 2018to 31 Dec 2031
- 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 with DeSyne X2 stent
Who may be able to join
- Age 19 and more
- Intervention with DeSyne X2 drug-eluting coronary stent
- Agreed with written informed consent form
Who cannot join
- Intervention with DeSyne X2 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
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
South Korea6 sites, 2 recruiting
- Recruiting
Hallym Hospital
Incheon
Soo-han Kim, MD
Soo-han Kim, MD
- Recruiting
Asan Medical Hospital
Seoul
Seung-jung Park, MD
Seung-jung Park, MD
- Terminated
Korea University Guro Hospital
Seoul
- Withdrawn
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
- Terminated
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul
- Terminated
St.carollo Hospital
Suncheon
About this study
Official title: Evaluation of Effectiveness and Safety of DESyne X2 in Routine Clinical Practice; A Multicenter, Prospective Observational Study
This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice.
- Conditions
- Coronary Stenosis, Coronary Occlusion, Coronary Disease
- Being tested
- DESyne X2
- Keywords
- PCI, DES, real world
- Medical subject headings
- Coronary Stenosis, Coronary Occlusion, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DESyne X2Device
Novolimus-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Coronary stenosis | Not described Receives: Device: DESyne X2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite event rate
Death, non-fatal myocardial infarction, Target Vessel Revascularization
Measured: 1year
Secondary outcomes (10)
All death
Measured: 5years
Cardiac death
Measured: 5years
Myocardial infarction
Measured: 5years
Composite event of death or myocardial infarction
Measured: 5years
Composite event of cardiac death or myocardial infarction
Measured: 5years
Target Vessel revascularization
Measured: 5years
Target Lesion revascularization
Measured: 5years
Stent thrombosis
stent thrombosis as classified by an Academic Research Consortium
Measured: 5years
Stroke
Measured: 5years
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: 3days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start28 Nov 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies 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
- 1,000 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
- NCT03588481
- Sponsor's protocol ID
- AMCCV2018-09
- Acronym
- IRIS DESyne X2
- Status last verified
- Jun 2026
- First submitted
- 5 Jul 2018
- Last updated
- 24 Jun 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of DESyne X2 in Routine Clinical Practice; A Multicenter, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03588481
- Acronym / sponsor ID
- IRIS DESyne X2 / AMCCV2018-09
- Conditions
- Coronary Stenosis, Coronary Occlusion, Coronary Disease
- Keywords
- PCI, DES, real world
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 17 Jul 2018 (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.
This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary stenosis | – | Device: DESyne X2 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with DeSyne X2 stent
Key inclusion criteria (3 listed)
- Age 19 and more
- Intervention with DeSyne X2 drug-eluting coronary stent
- Agreed with written informed consent form
Key exclusion criteria (3 listed)
- Intervention with DeSyne X2 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 |
|---|---|---|
| DESyne X2Novolimus-eluting stent | Device | Coronary stenosis |
Primary outcome
Composite event rate
Time frame: 1year
Death, non-fatal myocardial infarction, Target Vessel Revascularization
10 secondary outcomes
All death
Time frame: 5years
Cardiac death
Time frame: 5years
Myocardial infarction
Time frame: 5years
Composite event of death or myocardial infarction
Time frame: 5years
Composite event of cardiac death or myocardial infarction
Time frame: 5years
Target Vessel revascularization
Time frame: 5years
Target Lesion revascularization
Time frame: 5years
Stent thrombosis
Time frame: 5years
Stroke
Time frame: 5years
Procedural success
Time frame: 3days
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 24 Jun 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.
6 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 Stenosis and Coronary Occlusion, run by Seung-Jung Park at 6 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Contact Jung-hee Ham, RN (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?
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 24 Jun 2026.