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

Seung-Jung Park11 sites in 1 country302 target enrollmentJanuary 2012

ConditionsCoronary Artery Disease

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Seung-Jung Park
Enrollment: 302
Locations: 11
Primary Endpoint: In-segment late luminal loss at 13 month follow-up
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

February 14, 2017

Last Updated

9 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

CardioVascular Research Foundation, Korea

Eligibility Criteria

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)

Outcomes

Primary Outcomes

In-segment late luminal loss at 13 month follow-up

Time Frame: 13 month post stenting

Secondary Outcomes

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)
1. All Death(12 month clinical follow-up)
6. Target vessel revascularization (ischemia-driven and clinically-driven)(12 month clinical follow-up)
10. In-stent late loss(13 month angiographic 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)
11. In-stent and in-segment restenosis(13 month angiographic follow-up)
12. Angiographic pattern of restenosis(13 month angiographic follow-up)
14. Incidence of late stent malapposition(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)
13. Volume of intimal hyperplasia(13 month IVUS follow-up)