Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent

Coronary Artery Disease Clinical Trial

Official title:

RESOLUTE-KOREA Registry - Registry to Evaluate the Efficacy of Zotarolimus-eluting Stent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00960908
• Other study ID #: RESOLUTE-KOREA
• Status: Recruiting
• Phase: Phase 4
• First received: August 14, 2009
• Last updated: August 17, 2009
• Start date: January 2009

Study information

• Verified date: August 2009
• Source: Seoul National University Hospital
• Contact: Kyung-Woo Park, MD, PhD
• Phone: 82-2-2072-0244
• Email: kwparkmd[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Endeavor Resolute stents
2nd generation ZES
• Endeavor Sprint stent
1st generation ZES

Locations

Country	Name	City	State
Korea, Republic of	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	Bundang CHA Medical Center	Seongnam
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Gangbuk Samsung Hospital	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Seoul Boramae Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Soonchunhyang University Hospital	Seoul
Korea, Republic of	St. Vincent's Hospital	Suwon
Korea, Republic of	Uijeongbu St. Mary's Hospital	Uijeongbu

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Medtronic

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)		12 months	Yes
Secondary	In-stent & In-segment Late Loss		9 months	Yes
Secondary	Stent Thrombosis		1 year	Yes
Secondary	Target Vessel Failure (composite of cardiac death, MI, and TVR)		12 months	Yes
Secondary	Any death, cardiac death, MI, TLR, TVR		1 year	Yes
Secondary	Composite rate of cardiac death and any MI		1 year	Yes
Secondary	Composite rate of all death and any MI		1 year	Yes
Secondary	Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization		1 year	Yes
Secondary	Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy		1 year	Yes
Secondary	Clinical device and procedural success		During the health care facility stay	Yes