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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Cypher
* Device: Endeavor Resolute


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cypher<br>Sirolimus-eluting stent | Device: Cypher<br>* Sirolimus-eluting stent<br>* Other names: Sirolimus-eluting stent;|
| Active Comparator: Endeavor Resolute<br>Zotarolimus-eluting Stent | Device: Endeavor Resolute<br>* Zotarolimus-eluting Stent<br>* Other names: Zotarolimus-eluting Stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment late luminal loss |  | 9 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Death |  | 1 year | 
| Cardiac death |  | 1 year | 
| Myocardial infarction (MI) |  | 1 year | 
| Composite of death or MI |  | 1 year | 
| Composite of cardiac death or MI |  | 1 year | 
| Target vessel revascularization (ischemia-driven and clinically-driven) |  | 1 year | 
| Target lesion revascularization (ischemia-driven and clinically-driven) |  | 1 year | 
| Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) |  | 12 months | 
| Stent thrombosis (ARC criteria) |  | 1 year | 
| 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 discharge from the index hospitalization (normal hospitalization is from 3 -4 days.) | at 3 days in average | 
| All death |  | one month | 
| All death |  | 9 months | 
| Cardiac death |  | one month | 
| Cardiac death |  | 9 months | 
| Myocardial infarction (MI) |  | one month | 
| Myocardial infarction (MI) |  | 9 months | 
| Composite of death or MI |  | one month | 
| Composite of death or MI |  | 9 months | 
| Composite of cardiac death or MI |  | one month | 
| Composite of cardiac death or MI |  | 9 months | 
| Target vessel revascularization (ischemia-driven and clinically-driven) |  | one month | 
| Target vessel revascularization (ischemia-driven and clinically-driven) |  | 9 months | 
| Target lesion revascularization (ischemia-driven and clinically-driven) |  | one month | 
| Target lesion revascularization (ischemia-driven and clinically-driven) |  | 9 months | 
| Stent thrombosis (ARC criteria) |  | one month | 
| Stent thrombosis (ARC criteria) |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Stent