Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent

• Conditions: Coronary Artery Disease

• Registration Number: NCT00960908
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the zotarolimus eluting stent (ZES) and to determine clinical device and procedural success during commercial use of ZES.

The investigators will compare 2nd generation ZE (Endeavor resolute, active prospective arm) with 1st generation ZES (Endeavor Sprint, retrospective arm).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Status Verified: 2009-08
• Study First Submitted: 2009-08-14
• Study First Submitted QC: 2009-08-17
• Last Update Submitted: 2009-08-17
• Study First Posted: 2009-08-18
• Last Update Posted: 2009-08-18
• Primary Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• The patient agrees to participate in this study by signing the informed consent form.
• Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.

Exclusion Criteria

• There are no exclusion criteria for this registry.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)	12 months

Secondary Outcome Measures

Name	Time	Method
In-stent & In-segment Late Loss	9 months
Stent Thrombosis	1 year
Target Vessel Failure (composite of cardiac death, MI, and TVR)	12 months
Any death, cardiac death, MI, TLR, TVR	1 year
Composite rate of cardiac death and any MI	1 year
Composite rate of all death and any MI	1 year
Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization	1 year
Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy	1 year
Clinical device and procedural success	During the health care facility stay

Trial Locations

Locations (19)

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

Yongnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Chonbuk National Univesity Hospital; 🇰🇷 Iksan, Korea, Republic of

Inje University Ilsan Paik Hospital; 🇰🇷 Ilsan, Korea, Republic of

National Health Insurance Corporation Ilsan Hospital; 🇰🇷 Ilsan, Korea, Republic of

Gachon Kil Medical Center; 🇰🇷 Inchon, Korea, Republic of

Inha University Hospital; 🇰🇷 Inchon, Korea, Republic of

Gyeongsang National University Hospital; 🇰🇷 Jinju, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of

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