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

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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: percutaneous coronary intervention

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 Type: Interventional
• Enrollment (Actual): 302
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chuncheon, Korea, Republic of
    • Gangwon National Univ. Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of
    • Kyungpook National University Hospital
  • Daejeon, Korea, Republic of
    • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Ilsan, Korea, Republic of
    • National Health Insurance Service Ilsan Hospital
  • Seoul, Korea, Republic of
    • KyungHee University Medical Center
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Yeouido St. Mary's Hospital
  • Suncheon, Korea, Republic of
    • St.carollo Hospital
  • Yangsan, Korea, Republic of
    • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: Abbott; CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): February 14, 2017
• Study Completion (Actual): February 14, 2017

Study Registration Dates

• First Submitted: December 8, 2011
• First Submitted That Met QC Criteria: December 9, 2011
• First Posted (Estimate): December 12, 2011

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: drug eluting stents; long lesions
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CVRF2011-9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not a publicly funded trial.