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Clinical Trials/NCT00960908
NCT00960908UnknownNot Applicable

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

Seoul National University Hospital19 sites in 1 country4,000 target enrollmentStarted: January 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
4,000
Locations
19
Primary Endpoint
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)

Time Frame: 12 months

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other

Study Sites (19)

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