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RecruitingNCT01186133IRIS-DESUpdated Jun 30, 2026

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

An observational study in Coronary Artery Disease and Percutaneous Transluminal Coronary Angioplasty, sponsored by Seung-Jung Park. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by Seung-Jung Park · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50,000
Ages
19 Years and older
Sex
All
01

Study 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 the detailed description

Consecutive patients receiving New DES without a mixture of other DES

02

Conditions studied

  • Coronary Artery Disease
  • Percutaneous Transluminal Coronary Angioplasty

Keywords

  • coronary disease
  • drug eluting stent
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

consecutive patients amenable to PCI

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with a mixture of several DES
  • terminal illness with life expectancy less than 1 year
  • patients with cardiogenic shock
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50,000 participants (estimated)

Groups and cohorts

  • DESSIAN

    consecutive patients receiving CYPHER stent

  • K-XIENCE

    consecutive patients receiving Xience stent

  • GENOUS

    consecutive patients receiving GENOUS stent

  • ELEMENT

    consecutive patients receiving PROMUS-ELEMENT stent

  • PRIME

    consecutive patients receiving XIENCE-PRIME stent

  • NOBORI

    consecutive patients receiving NOBORI stent

  • INTEGRITY

    consecutive patients receiving RESOLUTE-INTEGRITY stent

  • XPEDITION

    consecutive patients receiving XIENCE-XPEDITION stent

  • BIOMATRIX

    consecutive patients receiving BIOMATRIX stent

  • CILOTAX

    consecutive patients receiving CILOTAX stent

  • DEB

    consecutive patients receiving Drug eluting balloon

  • DESYNE

    consecutive patients receiving DESYNE stent

  • PREMIER

    consecutive patients receiving PROMUS-PREMIER stent

  • ORSIRO

    consecutive patients receiving ORSIRO stent

  • ONYX

    consecutive patients receiving ONYX stent

  • BVS

    consecutive patients receiving Bioresorbable Vascular Scaffold

  • BVS AMI

    consecutive acute myocardial infarction patients receiving Bioresorbable Vascular Scaffold

  • Ultimaster

    consecutive patients receiving Ultimaster stent

  • Synergy

    consecutive patients receiving Synergy stent

  • Biofreedom

    consecutive patients receiving Biofreedom stent

  • Firehawk

    consecutive patients receiving Firehawk stent

  • DESyne X2

    consecutive patients receiving DESyne X2 stent

  • Sierra

    consecutive patients receiving Sierra stent

  • Tansei

    consecutive patients receiving Tansei stent

  • Synergy XD and Synergy Megatron™

    consecutive patients receiving Synergy XD or Synergy Megatron™ stent

  • Xience-Skypoint

    consecutive patients receiving Xience-Skypoint stent

  • Coroflex ISAR NEO

    consecutive patients receiving Coroflex ISAR NEO stent

05

What researchers measure

Primary outcomes

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

    Time frame: at 12 months post procedure

Secondary outcomes

  1. Death (all-cause and cardiac)

    Time frame: at 12 months and annually up to 5 years

  2. Myocardial infarction

    Time frame: at 12 months and annually up to 5 years

  3. Stent thrombosis

    Time frame: at 12 months and annually up to 5 years

  4. Target-lesion and target-vessel revascularization

    Time frame: at 12 months and annually up to 5 years

  5. Stroke

    Time frame: at 12 months and annually up to 5 years

  6. Procedural success

    Time frame: at 1 day

06

Study locations

1 of 1 sites recruiting
  • Korean centres
    Multiple Locations, South Korea
    Recruiting
07

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT01186133
Lead sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Seung-Jung Park (MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea) — Sponsor-investigator
First posted
Aug 23, 2010
Start date
Jan 2009
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Jun 30, 2026

Study contacts

Seung-Jung Park, MD
Contact
sjpark@amc.seoul.kr
Duk-Woo Park, MD
Contact
dwpark@amc.seoul.kr
Seung-Jung Park, MD
study chair · Asan Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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