Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent

NCT ID: NCT00960908

Last Updated: 2009-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Resolute

Prospective recruitment of Resolute arm will start in March 2009

Endeavor Resolute stents

Intervention Type DEVICE

2nd generation ZES

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.

Endeavor Sprint stent

Intervention Type DEVICE

1st generation ZES

Interventions

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Endeavor Resolute stents

2nd generation ZES

Intervention Type DEVICE

Endeavor Sprint stent

1st generation ZES

Intervention Type DEVICE

Other Intervention Names

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Endeavor Resolute Endeavor Sprint

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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Hyo-Soo Kim, MD, PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

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Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status NOT_YET_RECRUITING

Yongnam University Medical Center

Daegu, , South Korea

Site Status NOT_YET_RECRUITING

Chungnam National University Hospital

Daejeon, , South Korea

Site Status NOT_YET_RECRUITING

Chonbuk National Univesity Hospital

Iksan, , South Korea

Site Status NOT_YET_RECRUITING

Inje University Ilsan Paik Hospital

Ilsan, , South Korea

Site Status NOT_YET_RECRUITING

National Health Insurance Corporation Ilsan Hospital

Ilsan, , South Korea

Site Status RECRUITING

Gachon Kil Medical Center

Inchon, , South Korea

Site Status NOT_YET_RECRUITING

Inha University Hospital

Inchon, , South Korea

Site Status RECRUITING

Gyeongsang National University Hospital

Jinju, , South Korea

Site Status NOT_YET_RECRUITING

Pusan National University Hospital

Pusan, , South Korea

Site Status NOT_YET_RECRUITING

Bundang CHA Medical Center

Seongnam, , South Korea

Site Status NOT_YET_RECRUITING

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status NOT_YET_RECRUITING

Gangbuk Samsung Hospital

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Kangdong Sacred Heart Hospital

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Seoul Boramae Hospital

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Soonchunhyang University Hospital

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

St. Vincent's Hospital

Suwon, , South Korea

Site Status NOT_YET_RECRUITING

Uijeongbu St. Mary's Hospital

Uijeongbu-si, , South Korea

Site Status NOT_YET_RECRUITING

Countries

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South Korea

Central Contacts

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Kyung-Woo Park, MD, PhD

Role: CONTACT

82-2-2072-0244

Il-Young Oh, MD

Role: CONTACT

82-2-2072-3757

Facility Contacts

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Young-Jin Choi, MD,PhD

Role: primary

Jong-Sun Park, MD,PhD

Role: primary

In-Whan Seong, MD,PhD

Role: primary

Jae-Keon Chae, MD,PhD

Role: primary

Seong-Yoon Lee, MD,PhD

Role: primary

Dong-Woon Chun, MD,PhD

Role: primary

Tae-Hoon Ahn, MD,PhD

Role: primary

Seong-Il Woo, MD,PhD

Role: primary

Jin-Yong Hwang, MD,PhD

Role: primary

Han-Cheol Lee, MD,PhD

Role: primary

Seong-Wook Lim, MD,PhD

Role: primary

Dong-Ju Choi, MD,PhD

Role: primary

Jin-Ho Kang, MD,PhD

Role: primary

Kyoo-Rok Han, MD,PhD

Role: primary

Sang-Hyun Kim, MD,PhD

Role: primary

Kyung-Woo Park, MD,PhD

Role: primary

Min-Soo Hyon, MD,PhD

Role: primary

Geon-Woong Moon, MD,PhD

Role: primary

Hee-Kyung Jeon, MD,PhD

Role: primary

Other Identifiers

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RESOLUTE-KOREA

Identifier Type: -

Identifier Source: org_study_id

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