Clinical trial NCT00960908: Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent
Official title: RESOLUTE-KOREA Registry - Registry to Evaluate the Efficacy of Zotarolimus-eluting Stent
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Zotarolimus
Drug eluting stent
Endeavor Resolute
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2009-08-18
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 4000 patients derived from a population of patients receiving percutaneous coronary intervention for ischemic heart disease will be enrolled in the present registry.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)
timeFrame: 12 months
Secondary outcomes:
measure: In-stent & In-segment Late Loss
timeFrame: 9 months
measure: Stent Thrombosis
timeFrame: 1 year
measure: Target Vessel Failure (composite of cardiac death, MI, and TVR)
timeFrame: 12 months
measure: Any death, cardiac death, MI, TLR, TVR
timeFrame: 1 year
measure: Composite rate of cardiac death and any MI
timeFrame: 1 year
measure: Composite rate of all death and any MI
timeFrame: 1 year
measure: Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization
timeFrame: 1 year
measure: Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
timeFrame: 1 year
measure: Clinical device and procedural success
timeFrame: During the health care facility stay
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Daegu
country: Korea, Republic of
facility: Yongnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Iksan
country: Korea, Republic of
facility: Chonbuk National Univesity Hospital
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Ilsan
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
city: Inchon
country: Korea, Republic of
facility: Gachon Kil Medical Center
city: Inchon
country: Korea, Republic of
facility: Inha University Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA Medical Center
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Gangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Boramae Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-Soo Kim, MD, PhD
role: STUDY_CHAIR
References: