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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Cypher; Device: Endeavor Resolute

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 502
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Busan Paik Hospital
  • Busan, Korea, Republic of
    • Dong-A University Medical Center
  • Cheonan, Korea, Republic of
    • Soonchunhyang University Cheonan Hospital
  • Chuncheon, Korea, Republic of
    • Gangwon National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Kyung Hee University Medical Hospital
  • Cheon-nam
    • Suncheon, Cheon-nam, Korea, Republic of
      • Stcarollo Hospital
  • Chungnam
    • Daejeon, Chungnam, Korea, Republic of
      • Konyang University Hospital
  • Gyeong-gi
    • Bucheon, Gyeong-gi, Korea, Republic of
      • Soon Chun Hyang University Hospital Bucheon
    • Ilsan, Gyeong-gi, Korea, Republic of
      • Inje University Ilsan Paik Hospital
  • Kangwon
    • Wonju, Kangwon, Korea, Republic of
      • Wonju Christian Hospital
  • Kyung-book
    • Daegu, Kyung-book, Korea, Republic of
      • Yeungnam University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cypher; Sirolimus-eluting stent	Device: Cypher; Sirolimus-eluting stent; Other Names: Sirolimus-eluting stent
Active Comparator: Endeavor Resolute; Zotarolimus-eluting Stent	Device: Endeavor Resolute; Zotarolimus-eluting Stent; Other Names: Zotarolimus-eluting Stent

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death		1 year
Composite of death or MI		one month
Composite of death or MI		9 months
Composite of death or MI		1 year
Composite of cardiac death or MI		one month
Composite of cardiac death or MI		9 months
Composite of cardiac death or MI		1 year
Myocardial infarction (MI)		1 year
Target vessel revascularization (ischemia-driven and clinically-driven)		1 year
Target lesion revascularization (ischemia-driven and clinically-driven)		1 year
Cardiac death		one month
Stent thrombosis (ARC criteria)		one month
Cardiac death		9 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
Myocardial infarction (MI)		one month
Myocardial infarction (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)		9 months
All Death		1 year
Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)		12 months
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Ahn JM, Park DW, Kim YH, Song H, Cho YR, Kim WJ, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Han S, Lee SY, Lee BK, Cho JH, Yang TH, Lee NH, Yang JY, Park JS, Shin WY, Kim MH, Bae JH, Kim MK, Yoon J, Park SJ. Comparison of resolute zotarolimus-eluting stents and sirolimus-eluting stents in patients with de novo long coronary artery lesions: a randomized LONG-DES IV trial. Circ Cardiovasc Interv. 2012 Oct;5(5):633-40. doi: 10.1161/CIRCINTERVENTIONS.111.965673. Epub 2012 Oct 9.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: October 18, 2009
• First Submitted That Met QC Criteria: August 20, 2010
• First Posted (Estimate): August 23, 2010

Study Record Updates

• Last Update Posted (Estimate): August 8, 2012
• Last Update Submitted That Met QC Criteria: August 6, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Stent; Coronary Artery Disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: 2008-0086