NCT00960648

Brief Summary

The objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the everolimus-eluting stent (EES) and to determine clinical device and procedural success during commercial use of EES in the real world. The investigators will compare EES (Xience/Promus, prospective arm) with sirolimus-eluting stent (SES, Cypher, retrospective arm).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,056

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

5.8 years

First QC Date

August 14, 2009

Last Update Submit

April 22, 2026

Conditions

Coronary Artery Disease

Keywords

EverolimusSirolimusDrug eluting stent

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)

Xience/Promus

Active prospective registration of patients receiving everolimus eluting stent

Device: Xience/Promus

Cypher

Retrospective historical controls that received sirolimus-eluting stent

Device: Cypher

Interventions

Xience/PromusDEVICE

Active prospective registration of patients receiving everolimus-eluting stent

Also known as: EES
Xience/Promus
CypherDEVICE

Retrospective historical controls that received sirolimus-eluting stent

Also known as: SES
Cypher

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Study Sites (18)

Dankook University Hospital

Cheonan, South Korea

Location

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

Kwangju Veterans Hospital

Gwangju, South Korea

Location

Chonbuk National University Hospital

Iksan, South Korea

Location

Wonkwang University Hospital

Iksan, South Korea

Location

Inje University Ilsan Paik Hospital

Ilsan, South Korea

Location

Gachon Kil Medical Center

Inchon, South Korea

Location

Presbyterian Medical Center

Jeonju, South Korea

Location

Gyeongsang National University Hospital

Jinju, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Kyung Hee University Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Yonsei University Medical Center

Seoul, South Korea

Location

St. Carollo Hospital

Suncheon, South Korea

Location

Related Publications (1)

  • Lee JM, Hahn JY, Kang J, Park KW, Chun WJ, Rha SW, Yu CW, Jeong JO, Jeong MH, Yoon JH, Jang Y, Tahk SJ, Gwon HC, Koo BK, Kim HS. Differential Prognostic Effect Between First- and Second-Generation Drug-Eluting Stents in Coronary Bifurcation Lesions: Patient-Level Analysis of the Korean Bifurcation Pooled Cohorts. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1318-1331. doi: 10.1016/j.jcin.2015.05.014.

    PMID: 26315734RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Hyo-Soo Kim, MD,PhD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 18, 2009

Study Start

April 1, 2008

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations

KR(18)