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

Recruiting

• Conditions: Percutaneous Transluminal Coronary Angioplasty; Coronary Artery Disease

• Registration Number: NCT01186133
• Lead Sponsor: Seung-Jung Park

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

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-18
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target- Vessel Revascularization (TVR)	at 12 months post procedure

Secondary Outcome Measures

Name	Time	Method
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
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
Stent thrombosis	at 12 months and annually up to 5 years
Procedural success	at 1 day

Trial Locations

Locations (1)

Korean centres; 🇰🇷 Multiple Locations, Korea, Republic of