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

Seung-Jung Park

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Treatments

Device: Cypher

Device: Endeavor Resolute

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01186094

2008-0086

Details and patient eligibility

About

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.

Full 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.

Enrollment

502 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).