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

• ClinicalTrials.gov Identifier: NCT01186133
• Recruitment Status: Recruiting
• First Posted: August 23, 2010
• Last Update Posted: December 18, 2023
• Sponsor: Seung-Jung Park
• Collaborator: CardioVascular Research Foundation, Korea
• Information provided by (Responsible Party): Seung-Jung Park, CardioVascular Research Foundation, Korea

Tracking Information

• First Submitted Date: August 19, 2010
• First Posted Date: August 23, 2010
• Last Update Posted Date: December 18, 2023
• Study Start Date: January 2009
• Estimated Primary Completion Date: December 2030 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 6, 2021): Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) [ Time Frame: at 12 months post procedure ]
• Original Primary Outcome Measures (submitted: August 20, 2010): composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) [ Time Frame: at 12 months post procedure ]

Current Secondary Outcome Measures (submitted: September 6, 2021)

• 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 ]

Original Secondary Outcome Measures (submitted: August 20, 2010)

• death (all-cause and cardiac) [ Time Frame: at 12 months ]
• myocardial infarction [ Time Frame: at 12 months ]
• stent thrombosis [ Time Frame: at 12 months ]
• target-lesion and target-vessel revascularization [ Time Frame: at 12 months ]
• procedural success [ Time Frame: at 1 day ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice
• Official Title: Evaluation of Effectiveness and Safety of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice
• 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.
• Detailed Description: Consecutive patients receiving New DES without a mixture of other DES
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: consecutive patients amenable to PCI

Condition

• Coronary Artery Disease
• Percutaneous Transluminal Coronary Angioplasty

• Intervention: Not Provided

Study Groups/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

Publications *

• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 1, 2023): 50000
• Original Estimated Enrollment (submitted: August 20, 2010): 11000
• Estimated Study Completion Date: December 2030
• Estimated Primary Completion Date: December 2030 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Seung-Jung Park, MD; sjpark@amc.seoul.kr

Contact: Duk-Woo Park, MD; dwpark@amc.seoul.kr

• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01186133
• Other Study ID Numbers: 2010-035
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Seung-Jung Park, CardioVascular Research Foundation, Korea
• Original Responsible Party: Clinical Research Center, Asan Medical Center
• Current Study Sponsor: Seung-Jung Park
• Original Study Sponsor: CardioVascular Research Foundation, Korea
• Collaborators: CardioVascular Research Foundation, Korea

Investigators

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

• PRS Account: CardioVascular Research Foundation, Korea
• Verification Date: December 2023