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

NCT01186133 | Recruiting DMC

• 1 other identifier: 2010-035
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Percutaneous Transluminal Coronary Angioplasty

Keywords

coronary disease; drug eluting stent

Outcome Measures

Primary Outcomes (1)

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

  at 12 months post procedure

Secondary Outcomes (6)

• Death (all-cause and cardiac)

  at 12 months and annually up to 5 years

• Myocardial infarction

  at 12 months and annually up to 5 years

• Stent thrombosis

  at 12 months and annually up to 5 years

• Target-lesion and target-vessel revascularization

  at 12 months and annually up to 5 years

• Stroke

  at 12 months and annually up to 5 years

Study Arms (27)

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

consecutive patients amenable to PCI

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (1)

Korean centres

Multiple Locations, South Korea

RECRUITING

Related Publications (8)

• 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.

  PMID: 38199751 DERIVED

• 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.

  PMID: 36339122 DERIVED

• 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.

  PMID: 36338165 DERIVED

• 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.

  PMID: 32891400 DERIVED

• 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.

  PMID: 32473888 DERIVED

• 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.

  PMID: 32310851 DERIVED

• 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.

  PMID: 30745256 DERIVED

• 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.

  PMID: 29471933 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Seung-Jung Park, MD

  Asan Medical Center

  STUDY CHAIR

Central Study Contacts

Seung-Jung Park, MD

CONTACT

sjpark@amc.seoul.kr

Duk-Woo Park, MD

CONTACT

dwpark@amc.seoul.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: January 1, 2009
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

KR (1)