AzTrials
AzTrials

Coronary Artery DiseaseIRIS-DESNCT01186133

Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice

An observational study of Coronary Artery Disease and Percutaneous Transluminal Coronary Angioplasty, run by Seung-Jung Park at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The objective of this study is to evaluate effectiveness and safety of the new drug-eluting stent (DES), as compared with the first-,second-,third-, and fourth-generation DES, in the "real world" daily practice. Read more about this study

Who is it for?
Ages 19 years and older
How many people
50,000 participants
Where
1 siteSouth Korea
Study dates
Jan 2009to Dec 2030
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: consecutive patients amenable to PCI

Who may be able to join

  • coronary disease amenable to percutaneous coronary intervention (PCI)
  • no clinical and lesion limitations

Who cannot join

  • patients with a mixture of several DES
  • terminal illness with life expectancy less than 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.

Seung-Jung Park, MD contact

sjpark@amc.seoul.kr

Duk-Woo Park, MD contact

dwpark@amc.seoul.kr

South Korea1 site, 1 recruiting

  • Korean centres

    Multiple Locations

    Recruiting

Other trials in South Korea

About this study

Official title: Evaluation of Effectiveness and Safety of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice

The objective of this study is to evaluate effectiveness and safety of the new drug-eluting stent (DES), as compared with the first-,second-,third-, and fourth-generation DES, in the "real world" daily practice.

Read the detailed description

Consecutive patients receiving New DES without a mixture of other DES

Keywords
coronary disease, drug eluting stent
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.

Study groups in NCT01186133
Study groupRoleWhat they receive
DESSIANconsecutive patients receiving CYPHER stent
K-XIENCEconsecutive patients receiving Xience stent
GENOUSconsecutive patients receiving GENOUS stent
ELEMENTconsecutive patients receiving PROMUS-ELEMENT stent
PRIMEconsecutive patients receiving XIENCE-PRIME stent
NOBORIconsecutive patients receiving NOBORI stent
INTEGRITYconsecutive patients receiving RESOLUTE-INTEGRITY stent
XPEDITIONconsecutive patients receiving XIENCE-XPEDITION stent
BIOMATRIXconsecutive patients receiving BIOMATRIX stent
CILOTAXconsecutive patients receiving CILOTAX stent
DEBconsecutive patients receiving Drug eluting balloon
DESYNEconsecutive patients receiving DESYNE stent
PREMIERconsecutive patients receiving PROMUS-PREMIER stent
ORSIROconsecutive patients receiving ORSIRO stent
ONYXconsecutive patients receiving ONYX stent
BVSconsecutive patients receiving Bioresorbable Vascular Scaffold
BVS AMIconsecutive acute myocardial infarction patients receiving Bioresorbable Vascular Scaffold
Ultimasterconsecutive patients receiving Ultimaster stent
Synergyconsecutive patients receiving Synergy stent
Biofreedomconsecutive patients receiving Biofreedom stent
Firehawkconsecutive patients receiving Firehawk stent
DESyne X2consecutive patients receiving DESyne X2 stent
Sierraconsecutive patients receiving Sierra stent
Tanseiconsecutive patients receiving Tansei stent
Synergy XD and Synergy Megatron™consecutive patients receiving Synergy XD or Synergy Megatron™ stent
Xience-Skypointconsecutive patients receiving Xience-Skypoint stent
Coroflex ISAR NEOconsecutive patients receiving Coroflex ISAR NEO stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)

    Measured: at 12 months post procedure

Secondary outcomes (6)

  1. Death (all-cause and cardiac)

    Measured: at 12 months and annually up to 5 years

  2. Myocardial infarction

    Measured: at 12 months and annually up to 5 years

  3. Stent thrombosis

    Measured: at 12 months and annually up to 5 years

  4. Target-lesion and target-vessel revascularization

    Measured: at 12 months and annually up to 5 years

  5. Stroke

    Measured: at 12 months and annually up to 5 years

  6. Procedural success

    Measured: at 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2010 (estimated)
  2. Study startJan 2009
  3. Primary completionDec 2030 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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
50,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01186133
Sponsor's protocol ID
2010-035
Acronym
IRIS-DES
Status last verified
Jun 2026
First submitted
19 Aug 2010
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Kim TO, Kang DY, Ahn JM, Kim MJ, Lee PH, Kim H, Choi Y, Lee J, Lee JM, Jo HH, Park YS, Lim SM, Park SJ, Park DW. Impact of Target Lesion Revascularization on Long-Term Mortality After Percutaneous Coronary Intervention for Left Main Disease. JACC Cardiovasc Interv. 2024 Jan 8;17(1):32-42. doi: 10.1016/j.jcin.2023.10.068.

    PubMed 38199751

  • Jeong YJ, Hyun J, Lee J, Kim JH, Yang Y, Choe K, Lee JS, Park H, Cho SC, Kang DY, Lee PH, Ahn JM, Park DW, Park SJ; IRIS-DES Registry Investigators. Comparison of Contemporary Drug-Eluting Stents in Patients Undergoing Complex High-Risk Indicated Procedures. JACC Asia. 2022 Mar 1;2(2):182-193. doi: 10.1016/j.jacasi.2021.10.008. eCollection 2022 Apr.

    PubMed 36339122

  • Yang Y, Hyun J, Lee J, Kim JH, Lee JB, Kang DY, Lee PH, Ahn JM, Park DW, Park SJ; IRIS-DES Registry Investigators. Effectiveness and Safety of Contemporary Drug-Eluting Stents in Patients With Diabetes Mellitus. JACC Asia. 2021 Sep 21;1(2):173-184. doi: 10.1016/j.jacasi.2021.07.009. eCollection 2021 Sep.

    PubMed 36338165

  • Park S, Ahn JM, Kim TO, Park H, Cho SC, Kang DY, Lee PH, Park DW, Park SJ; IRIS-DES Registry Investigators. Incidence and Impact of Thrombocytopenia in Patients Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents. Am J Cardiol. 2020 Nov 1;134:55-61. doi: 10.1016/j.amjcard.2020.07.059. Epub 2020 Aug 16.

    PubMed 32891400

  • Park H, Ahn JM, Kang DY, Lee JB, Park S, Ko E, Cho SC, Lee PH, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park SJ. Optimal Stenting Technique for Complex Coronary Lesions: Intracoronary Imaging-Guided Pre-Dilation, Stent Sizing, and Post-Dilation. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1403-1413. doi: 10.1016/j.jcin.2020.03.023. Epub 2020 May 27.

    PubMed 32473888

  • Lee CH, Ahn JM, Lee KS, Kang DY, Lee PH, Lee SW, Lee CW, Park SW, Park DW, Park SJ; IRIS-DES Registry Investigators. Prevalence, predictors, prognostic significance, and effect of techniques on outcomes of coronary lesion calcification following implantation of drug-eluting stents: a patient-level pooled analysis of stent-specific, multicenter, prospective IRIS-DES registries. Coron Artery Dis. 2021 Jan;32(1):42-50. doi: 10.1097/MCA.0000000000000896.

    PubMed 32310851

  • Lee CH, Kang DY, Han M, Hur SH, Rha SW, Her SH, Seung KB, Kim KS, Lee PH, Ahn JM, Lee SW, Park SW, Park DW, Park SJ; IRIS-DES Registry Investigators. Differential cutoff points and clinical impact of stent parameters of various drug-eluting stents for predicting major adverse clinical events: An individual patient data pooled analysis of seven stent-specific registries and 17,068 patients. Int J Cardiol. 2019 May 1;282:17-23. doi: 10.1016/j.ijcard.2019.01.108. Epub 2019 Feb 2.

    PubMed 30745256

  • Lee PH, Kwon O, Ahn JM, Lee CH, Kang DY, Lee JB, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park DW, Park SJ. Safety and Effectiveness of Second-Generation Drug-Eluting Stents in Patients With Left Main Coronary Artery Disease. J Am Coll Cardiol. 2018 Feb 27;71(8):832-841. doi: 10.1016/j.jacc.2017.12.032.

    PubMed 29471933

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Percutaneous Transluminal Coronary Angioplasty, 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 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: looking for participants now, as of the sponsor's last update on 30 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 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 Seung-Jung Park, MD (sjpark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) (time frame: at 12 months post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01186133, which also lists 8 linked publications.

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 30 Jun 2026.

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