Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: (LONG-DES-IV)

Seung-Jung Park502 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

502

Conditions

Coronary Artery Disease

Interventions

CypherDEVICE

Sirolimus-eluting stent

Endeavor ResoluteDEVICE

Zotarolimus-eluting Stent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (12)

Stcarollo Hospital

Suncheon, Cheon-nam, South Korea

Konyang University Hospital

Daejeon, Chungcheongnam-do, South Korea

Wonju Christian Hospital

Wŏnju, Gangwon-do, South Korea

Outcomes

Primary Outcomes

In-segment late luminal loss

Time frame: 9 month follow-up

Secondary Outcomes

All Death

Time frame: 1 year

Cardiac death

Time frame: 1 year

Myocardial infarction (MI)

Time frame: 1 year

Composite of death or MI

Time frame: 1 year

Composite of cardiac death or MI

Time frame: 1 year

Target vessel revascularization (ischemia-driven and clinically-driven)

Time frame: 1 year

Target lesion revascularization (ischemia-driven and clinically-driven)

Time frame: 1 year

Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)

Time frame: 12 months

Stent thrombosis (ARC criteria)

Time frame: 1 year

In-stent late loss at 9 month angiographic follow-up

Time frame: at 9 month angiographic follow-up

In-stent and in-segment restenosis at 9 month angiographic follow-up

Time frame: at 9 month angiographic follow-up

Data from ClinicalTrials.gov

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