Brief Summary

The purpose of this study is to establish the safety and long-term effectiveness of coronary stenting with the ABT 578-eluting balloon expandable stent (Medtronic, Minneapolis, MN) vs. the sirolimus-eluting balloon expandable stent (Cordis Johnson \& Johnson, Warren, New Jersey) and the paclitaxel-eluting stent (Taxus liberte, Boston Scientific) for the treatment of coronary stenosis in routine clinical practice.

Trial Health

On Track

Trial Health Score

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

Enrollment

2,645

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline

Completed

Started Oct 2006

Geographic Reach

1 country

20 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

2.3 years study duration

Study Start

First participant enrolled

October 1, 2006

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed

Last Updated

August 21, 2012

Status Verified

August 1, 2012

Enrollment Period

2.3 years

First QC Date

January 3, 2007

Last Update Submit

August 20, 2012

Conditions

Coronary Artery Disease

Keywords

Coronary Artery DiseaseStent

Outcome Measures

Primary Outcomes (1)

The composite of death (all cause-mortality), myocardial infarction, and ischemia-driven target vessel revascularization
at 12 months after the index procedure

Secondary Outcomes (9)

All-cause Death
In-hospital, 30 days, 6 months, 1 year, and thereafter annually upto 5 years
Cardiac death
In-hospital, 30 days, 6 months, 1 year, and thereafter annually upto 5 years
Myocardial infarction
In-hospital, 30 days, 6 months, 1 year, and thereafter annually upto 5 years
Target vessel revascularization (all and ischemia-driven)
In-hospital, 30 days, 6 months, 1 year, and thereafter annually upto 5 years
Target lesion revascularization (all and ischemia-driven)
In-hospital, 30 days, 6 months, 1 year, and thereafter annually upto 5 years
+4 more secondary outcomes

Study Arms (3)

Cypher

ACTIVE COMPARATOR

Sirolimus-eluting stent

Device: Cypher

Taxus Liberte

ACTIVE COMPARATOR

Paclitaxel-eluting stent

Device: Taxus Liberte

Endeavor

EXPERIMENTAL

Zotarolimus-eluting stent

Device: Endeavor

Interventions

EndeavorDEVICE

Zotarolimus-eluting stent

Also known as: Zotarolimus-eluting stent

Endeavor

CypherDEVICE

Sirolimus-eluting stent

Also known as: Sirolimus-eluting stent

Cypher

Taxus LiberteDEVICE

Paclitaxel-eluting stent

Also known as: Paclitaxel-eluting stent

Taxus Liberte

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The patient must be at least 18 years of age.
Significant coronary artery stenosis (\>50% by visual estimate)
Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention
The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

You may not qualify if:

The patient has a known hypersensitivity or contraindication to any of the following medications:
Heparin, Aspirin, Both Clopidogrel and Ticlopidine, Sirolimus, paclitaxel, ABT 578, Stainless steel and/or Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.
An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 12 months post enrollment.
Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Patients who have target lesion of in-stent restenosis at the stented segment of drug-eluting stent (in-stent restenosis of bare metal stent can be included).
Patients with EF\<30%.
Patients with cardiogenic shock
Acute STEMI patients within symptom onset \< 12 hours needing primary angioplasty
Creatinine level \> 3.0mg/dL or dependence on dialysis.
Severe hepatic dysfunction (AST and ALT \> 3 times upper normal reference values).
Patients with left main stem stenosis (\>50% by visual estimate)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Seung-Jung Parklead
Medtronic Vascularcollaborator

Study Sites (20)

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Asan Medical Center

Gangneung, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

NHIC Ilsan Hospital

Ilsan, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Pusan Natioanal University Hospital

Pusan, South Korea

Location

Hallym University Sacred Heart Hospital

Pyeongchon, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Korea University Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

St.Mary's Catholic Medical Center

Seoul, South Korea

Location

Yonsei University Medical Center

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Yonsei University Wonju Christian Hospital

Wŏnju, South Korea

Location

Related Publications (2)

Kang SJ, Mintz GS, Park DW, Lee SW, Kim YH, Lee CW, Han KH, Kim JJ, Park SW, Park SJ. Comparison of zotarolimus-eluting stents with sirolimus-eluting and paclitaxel-eluting stents: intimal hyperplasia and vascular changes assessed by volumetric intravascular ultrasound analysis. Circ Cardiovasc Interv. 2011 Apr 1;4(2):139-45. doi: 10.1161/CIRCINTERVENTIONS.110.957936. Epub 2011 Mar 1.
PMID: 21364151DERIVED
Park DW, Kim YH, Yun SC, Kang SJ, Lee SW, Lee CW, Park SW, Seong IW, Lee JH, Tahk SJ, Jeong MH, Jang Y, Cheong SS, Yang JY, Lim DS, Seung KB, Chae JK, Hur SH, Lee SG, Yoon J, Lee NH, Choi YJ, Kim HS, Kim KS, Kim HS, Hong TJ, Park HS, Park SJ. Comparison of zotarolimus-eluting stents with sirolimus- and paclitaxel-eluting stents for coronary revascularization: the ZEST (comparison of the efficacy and safety of zotarolimus-eluting stent with sirolimus-eluting and paclitaxel-eluting stent for coronary lesions) randomized trial. J Am Coll Cardiol. 2010 Oct 5;56(15):1187-95. doi: 10.1016/j.jacc.2010.03.086.
PMID: 20883925DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

Seung-Jung Park, MD, PhD
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Comparison of the Efficacy of Zotarolimus(ABT 578)-Eluting Stent versus Sirolimus-Eluting Stent versus Paclitaxel-Eluting Stent for Coronary Lesions: The Prospective, Randomized, and Multi-center Trial

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 4, 2007

Study Start

October 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

August 21, 2012

Record last verified: 2012-08

Locations

KR(20)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (3)

Cypher

Taxus Liberte

Endeavor

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (20)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations