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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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