LONG-DES VI (Drug Eluting Stent for Long Lesions in Coronary Artery)

Study Overview
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Brief Summary
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This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) for very long coronary lesions.

Detailed Description
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Following angiography, patients with significant diameter stenosis > 50% and lesion length (> 50mm) requiring at least 2 multiple long-stent placement by visual estimation and eligible for LONG-DES VI trial inclusion and exclusion criteria will be randomized 1:1 to zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) by the stratified randomization method.

Official Title
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Percutaneous Treatment of Very LONG Native Coronary Lesions With Drug-Eluting Stent-VI: Everolimus-eluting Versus Zotarolimus-Eluting Stents

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age more than 20 years Significant native coronary artery stenosis (> 50% by visual estimate) with lesion length of more than 50mm, which requires at least 2 multiple long stent placement without intervening normal segment Patients with silent ischemia, stable or unstable angina pectoris, and Non-ST-elevation myocardial infarction (NSTEMI) 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, zotarolimus, 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) However, non-target vessel In-stent restenosis is permitted Patients with EF < 30% Serum creatinine level >=2.0mg/dL or dependence on dialysis Patients with left main stem stenosis (> 50% visual estimate)

Ages Eligible for Study
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Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: zotarolimus-eluting stent<br>Resolute Integrity or Resolute Onyx stent | Device: percutaneous coronary intervention<br>* drug eluting stent implantation<br>* Other names: Xience Prime or Xience Xpedition or Xience Alpine stent;|
| Experimental: everolimus-eluting stent<br>Xience Prime or Xience Xpedition or Xience Alpine stent | Device: percutaneous coronary intervention<br>* drug eluting stent implantation<br>* Other names: Xience Prime or Xience Xpedition or Xience Alpine stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment late luminal loss at 13 month follow-up |  | 13 month post stenting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. All Death |  | 12 month clinical follow-up | 
| 2. Cardiac death |  | 12 month clinical follow-up | 
| 3. Myocardial infarction (MI) |  | 12 month clinical follow-up | 
| 4. Composite of death or MI |  | 12 month clinical follow-up | 
| 5. Composite of cardiac death or MI |  | 12 month clinical follow-up | 
| 6. Target vessel revascularization (ischemia-driven and clinically-driven) |  | 12 month clinical follow-up | 
| 7. Target lesion revascularization (ischemia-driven and clinically-driven) |  | 12 month clinical follow-up | 
| 8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) |  | 12 month clinical follow-up | 
| 9. Stent thrombosis (ARC criteria) |  | 12 month clinical follow-up | 
| 10. In-stent late loss |  | 13 month angiographic follow-up | 
| 11. In-stent and in-segment restenosis |  | 13 month angiographic follow-up | 
| 12. Angiographic pattern of restenosis |  | 13 month angiographic follow-up | 
| 13. Volume of intimal hyperplasia | sub-study | 13 month IVUS follow-up | 
| 14. Incidence of late stent malapposition | sub-study | 13 month IVUS follow-up | 
| 15. 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 |  | 2-3 days post stenting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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long lesions, drug eluting stents