Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent

August 17, 2009 updated by: Seoul National University Hospital

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of
        • Not yet recruiting
        • Hallym University Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Young-Jin Choi, MD,PhD
      • Daegu, Korea, Republic of
        • Not yet recruiting
        • Yongnam University Medical Center
        • Contact:
        • Principal Investigator:
          • Jong-Sun Park, MD,PhD
      • Daejeon, Korea, Republic of
        • Not yet recruiting
        • Chungnam National University Hospital
        • Contact:
        • Principal Investigator:
          • In-Hwan Seong, MD,PhD
      • Iksan, Korea, Republic of
        • Not yet recruiting
        • Chonbuk National Univesity Hospital
        • Contact:
        • Principal Investigator:
          • Jae-Keon Chae, MD,PhD
      • Ilsan, Korea, Republic of
        • Not yet recruiting
        • Inje University Ilsan Paik Hospital
        • Contact:
        • Principal Investigator:
          • Seong-Yoon Lee, MD,PhD
      • Ilsan, Korea, Republic of
        • Recruiting
        • National Health Insurance Corporation Ilsan Hospital
        • Contact:
        • Principal Investigator:
          • Dong-Woon Chun, MD,PhD
      • Inchon, Korea, Republic of
        • Not yet recruiting
        • Gachon Kil Medical Center
        • Contact:
        • Principal Investigator:
          • Tae-Hoon Ahn, MD,PhD
      • Inchon, Korea, Republic of
        • Recruiting
        • Inha University Hospital
        • Contact:
        • Principal Investigator:
          • Seong-Il Woo, MD,PhD
      • Jinju, Korea, Republic of
        • Not yet recruiting
        • Gyeongsang National University Hospital
        • Contact:
        • Principal Investigator:
          • Jin-Yong Hwang, MD,PhD
      • Pusan, Korea, Republic of
        • Not yet recruiting
        • Pusan National University Hospital
      • Seongnam, Korea, Republic of
        • Not yet recruiting
        • Bundang CHA Medical Center
        • Contact:
        • Principal Investigator:
          • Seong-Wook Lim, MD,PhD
      • Seongnam, Korea, Republic of
        • Not yet recruiting
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Hyo-Soo Kim, MD,PhD
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Gangbuk Samsung Hospital
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Kangdong Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Kyoo-Rok Han, MD,PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul Boramae Hospital
        • Contact:
        • Principal Investigator:
          • Sang-Hyun Kim, MD,PhD
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Soonchunhyang University Hospital
      • Suwon, Korea, Republic of
        • Not yet recruiting
        • St. Vincent's Hospital
      • Uijeongbu, Korea, Republic of
        • Not yet recruiting
        • Uijeongbu St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Hee-Kyung Jeon, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Resolute
Prospective recruitment of Resolute arm will start in March 2009
Device: Endeavor Resolute stents
2nd generation ZES
Other Names:
  • Endeavor Resolute
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.
Device: Endeavor Sprint stent
1st generation ZES
Other Names:
  • Endeavor Sprint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major Adverse Cardiac Events (composite of cardiac death, non-fatal MI, target lesion revascularization)
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

August 17, 2009

First Posted (Estimate)

August 18, 2009

Study Record Updates

Last Update Posted (Estimate)

August 18, 2009

Last Update Submitted That Met QC Criteria

August 17, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESOLUTE-KOREA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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