Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent
RESOLUTE-KOREA Registry - Registry to Evaluate the Efficacy of Zotarolimus-eluting Stent
1 other identifier
observational
4,000
1 country
19
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 14, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedAugust 18, 2009
August 1, 2009
3 years
August 14, 2009
August 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)
12 months
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (2)
Resolute
Prospective recruitment of Resolute arm will start in March 2009
Endeavor
The retrospective recruiting period of Endeavor arm comprises a fixed 2-year time between January 2006 and December 2008. The patients, who were treated with Endeavor in that period, will be enrolled if they agree to participate in this study.
Interventions
Eligibility Criteria
Approximately 4000 patients derived from a population of patients receiving percutaneous coronary intervention for ischemic heart disease will be enrolled in the present registry.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Medtroniccollaborator
Study Sites (19)
Hallym University Sacred Heart Hospital
Anyang, South Korea
Yongnam University Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Chonbuk National Univesity Hospital
Iksan, South Korea
Inje University Ilsan Paik Hospital
Ilsan, South Korea
National Health Insurance Corporation Ilsan Hospital
Ilsan, South Korea
Gachon Kil Medical Center
Inchon, South Korea
Inha University Hospital
Inchon, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
Pusan National University Hospital
Pusan, South Korea
Bundang CHA Medical Center
Seongnam, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Gangbuk Samsung Hospital
Seoul, South Korea
Kangdong Sacred Heart Hospital
Seoul, South Korea
Seoul Boramae Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Soonchunhyang University Hospital
Seoul, South Korea
St. Vincent's Hospital
Suwon, South Korea
Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hyo-Soo Kim, MD, PhD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 14, 2009
First Posted
August 18, 2009
Study Start
January 1, 2009
Primary Completion
January 1, 2012
Last Updated
August 18, 2009
Record last verified: 2009-08