Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: Sirolimus vs. Zotarolimus-eluting Stent

Seung-Jung Park12 sites in 1 country502 target enrollmentMay 2009

ConditionsCoronary Artery Disease

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Seung-Jung Park
Enrollment: 502
Locations: 12
Primary Endpoint: In-segment late luminal loss
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This randomized study is a multi-center, randomized, study to compare the efficacy of sirolimus (Cypher) versus zotarolimus-eluting stent (Endeavor Resolute) implantation for long coronary lesions.

Detailed Description

Following angiography, patients with significant diameter stenosis \>50% and lesion length (\> 25mm) requiring single or multiple long-stent placement (total stent length\>28mm) by visual estimation and eligible for LONG-DES IV trial inclusion and exclusion criteria will be randomized 1:1 to a) CYPHER and b) ENDEAVOR RESOLUTE stent by the stratified randomization method.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

June 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seung-Jung Park

Responsible Party

Sponsor Investigator

Principal Investigator

Seung-Jung Park

MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

CardioVascular Research Foundation, Korea

Eligibility Criteria

Inclusion Criteria

•The patient must be at least 18 years of age.
•Significant native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (\>=28mm)
•Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction
•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.

Exclusion Criteria

•Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus.
•An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
•Acute ST-segment-elevation MI or cardiogenic shock
•Terminal illness with life expectancy \<1 year
•Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
•In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment, non-target vessel ISR is permitted)
•Patients with EF\<30%.
•Serum creatinine level \>=3.0mg/dL or dependence on dialysis.
•Patients with left main stem stenosis (\>50% by visual estimate).

Outcomes

Primary Outcomes

In-segment late luminal loss

Time Frame: 9 month follow-up

Secondary Outcomes

All Death(1 year)
Cardiac death(9 months)
Myocardial infarction (MI)(9 months)
Composite of death or MI(9 months)
Composite of cardiac death or MI(9 months)
Target vessel revascularization (ischemia-driven and clinically-driven)(9 months)
Target lesion revascularization (ischemia-driven and clinically-driven)(9 months)
Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)(12 months)
Stent thrombosis (ARC criteria)(9 months)
In-stent late loss at 9 month angiographic follow-up(at 9 month angiographic follow-up)
In-stent and in-segment restenosis at 9 month angiographic follow-up(at 9 month angiographic follow-up)
Angiographic pattern of restenosis at 9 month angiographic follow-up(at 9 month angiographic follow-up)
Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study)(at 9 month angiographic follow-up)
Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study)(at 9 month angiographic follow-up)
Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay.(at 3 days in average)
All death(9 months)