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

Phase 4

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Device: percutaneous coronary intervention

• Registration Number: NCT01489761
• Lead Sponsor: Seung-Jung Park

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.

Study Timeline

• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-09
• Study First Posted: 2011-12-12
• Study Start: 2012-01
• Status Verified: 2017-02
• Primary Completion: 2017-02-14
• Study Completion: 2017-02-14
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 302

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
zotarolimus-eluting stent	percutaneous coronary intervention	Resolute Integrity or Resolute Onyx stent
everolimus-eluting stent	percutaneous coronary intervention	Xience Prime or Xience Xpedition or Xience Alpine stent

Primary Outcome Measures

Name	Time	Method
In-segment late luminal loss at 13 month follow-up	13 month post stenting

Secondary Outcome Measures

Name	Time	Method
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	sub-study
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	sub-study

Trial Locations

Locations (11)

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Gangwon National Univ. Hospital; 🇰🇷 Chuncheon, Korea, Republic of

The Catholic University of Korea, Daejeon ST. Mary's Hospital; 🇰🇷 Daejeon, Korea, Republic of

National Health Insurance Service Ilsan Hospital; 🇰🇷 Ilsan, Korea, Republic of

Kyungpook National university hospital; 🇰🇷 Daegu, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyunghee University Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Yeouido St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

St.carollo Hospital; 🇰🇷 Suncheon, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of