Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-V:Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents

Seung-Jung Park11 sites in 1 country500 target enrollmentAugust 2010

ConditionsCoronary Artery Disease

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Seung-Jung Park
Enrollment: 500
Locations: 11
Primary Endpoint: In-segment late luminal loss
Status: Completed
Last Updated: 12 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 biolimus A9-eluting stent (Nobori) vs. everolimus-eluting stent (Promus Element) 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 V trial inclusion and exclusion criteria will be randomized 1:1 to a) NOBORI and b) PROMUS-ELEMENT stent by the stratified randomization method.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

August 2013

Last Updated

12 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 angiographic follow-up

Secondary Outcomes

Composite of cardiac death or MI(1 year)
Death (all-cause and cardiac)(9 months)
target-lesion revascularization(9 months)
target-vessel revascularization(9 months)
8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)(12 months)
In-stent and in-segment restenosis(9 month angiographic follow-up)
In-stent late loss(9 month angiographic follow-up)
Angiographic pattern of restenosis(9 month angiographic follow-up)
stent thrombosis(ARC criteria)(9 months)
Procedural success(at 1 day)
Myocardial infarction(9 months)
Composite of death or MI(1 year)