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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01186133

Recruitment Status : Recruiting

First Posted : August 23, 2010

Last Update Posted : December 18, 2023

See Contacts and Locations

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

CardioVascular Research Foundation, Korea

Information provided by (Responsible Party):

Seung-Jung Park, CardioVascular Research Foundation, Korea

Study Description

Brief 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.

Condition or disease
Coronary Artery Disease Percutaneous Transluminal Coronary Angioplasty

Detailed Description:

Consecutive patients receiving New DES without a mixture of other DES

Study Design

Layout table for study information

Study Type :	Observational
Estimated Enrollment :	50000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Evaluation of Effectiveness and Safety of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice
Study Start Date :	January 2009
Estimated Primary Completion Date :	December 2030
Estimated Study Completion Date :	December 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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

Outcome Measures

Primary Outcome Measures :

Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) [ Time Frame: at 12 months post procedure ]

Secondary Outcome Measures :

Death (all-cause and cardiac) [ Time Frame: at 12 months and annually up to 5 years ]
Myocardial infarction [ Time Frame: at 12 months and annually up to 5 years ]
Stent thrombosis [ Time Frame: at 12 months and annually up to 5 years ]
Target-lesion and target-vessel revascularization [ Time Frame: at 12 months and annually up to 5 years ]
Stroke [ Time Frame: at 12 months and annually up to 5 years ]
Procedural success [ Time Frame: at 1 day ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	19 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

consecutive patients amenable to PCI

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186133

Contacts

Layout table for location contacts

Contact: Seung-Jung Park, MD		sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD		dwpark@amc.seoul.kr

Locations

Layout table for location information

Korea, Republic of
Korean centres	Recruiting
Multiple Locations, Korea, Republic of

Sponsors and Collaborators

Seung-Jung Park

CardioVascular Research Foundation, Korea

Investigators

Layout table for investigator information

Study Chair:	Seung-Jung Park, MD	Asan Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

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.

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.

Layout table for additonal information

Responsible Party:	Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:	NCT01186133
Other Study ID Numbers:	2010-035
First Posted:	August 23, 2010 Key Record Dates
Last Update Posted:	December 18, 2023
Last Verified:	December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:


coronary disease drug eluting stent

Additional relevant MeSH terms:

Layout table for MeSH terms

Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases	Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases

To Top