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

Seung-Jung Park1 site in 1 country50,000 target enrollmentJanuary 2009

ConditionsCoronary Artery Disease Percutaneous Transluminal Coronary Angioplasty

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Seung-Jung Park
Enrollment: 50000
Locations: 1
Primary Endpoint: Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)
Status: Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

December 2030

Last Updated

10 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Seung-Jung Park

Responsible Party

Sponsor Investigator

Principal Investigator

Seung-Jung Park

MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

CardioVascular Research Foundation, Korea

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

Outcomes

Primary Outcomes

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

Time Frame: at 12 months post procedure

Secondary Outcomes

Myocardial infarction(at 12 months and annually up to 5 years)
Death (all-cause and cardiac)(at 12 months and annually up to 5 years)
Stroke(at 12 months and annually up to 5 years)
Target-lesion and target-vessel revascularization(at 12 months and annually up to 5 years)
Stent thrombosis(at 12 months and annually up to 5 years)
Procedural success(at 1 day)