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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Percutaneous Transluminal Coronary Angioplasty

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