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NCT01186133 Clinical Trial

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

Coronary Artery Disease Clinical Trial

— IRIS-DES  

Official title:
Evaluation of Effectiveness and Safety of the First, Second, and New Drug-Eluting Stents in Routine Clinical Practice

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01186133
Other study ID # 2010-035
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2009
Est. completion date December 2030

Study information
Verified date December 2023
Source CardioVascular Research Foundation, Korea
Contact Seung-Jung Park, MD
Email sjpark@amc.seoul.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

Consecutive patients receiving New DES without a mixture of other DES

Recruitment information / eligibility
Status Recruiting
Enrollment 50000
Est. completion date December 2030
Est. primary completion date December 2030
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Korean centres Multiple Locations

Sponsors (2)
Lead Sponsor Collaborator
Seung-Jung Park CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR) at 12 months post procedure
Secondary Death (all-cause and cardiac) at 12 months and annually up to 5 years
Secondary Myocardial infarction at 12 months and annually up to 5 years
Secondary Stent thrombosis at 12 months and annually up to 5 years
Secondary Target-lesion and target-vessel revascularization at 12 months and annually up to 5 years
Secondary Stroke at 12 months and annually up to 5 years
Secondary Procedural success at 1 day
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