Clinical trial NCT01186133: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Percutaneous Transluminal Coronary Angioplasty
Keywords: coronary disease
drug eluting stent
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2010-08-23
Enrollment: 50000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive patients amenable to PCI

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

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

Primary outcomes:
measure: Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
timeFrame: at 12 months post procedure
Secondary outcomes:
measure: Death (all-cause and cardiac)
timeFrame: at 12 months and annually up to 5 years
measure: Myocardial infarction
timeFrame: at 12 months and annually up to 5 years
measure: Stent thrombosis
timeFrame: at 12 months and annually up to 5 years
measure: Target-lesion and target-vessel revascularization
timeFrame: at 12 months and annually up to 5 years
measure: Stroke
timeFrame: at 12 months and annually up to 5 years
measure: Procedural success
timeFrame: at 1 day
Other outcomes:
Locations:
city: Multiple Locations
country: Korea, Republic of
facility: Korean centres
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.