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

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Device: Cypher Device: Endeavor Resolute	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: Sirolimus vs. Zotarolimus-eluting Stent

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Sirolimus Everolimus Temsirolimus

U.S. FDA Resources

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:

In-segment late luminal loss [ Time Frame: 9 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

All Death [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Cardiac death [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Myocardial infarction (MI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Composite of death or MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Composite of cardiac death or MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Stent thrombosis (ARC criteria) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
In-stent late loss at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
In-stent and in-segment restenosis at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
Angiographic pattern of restenosis at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study) [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study) [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
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. [ Time Frame: at 3 days in average ] [ Designated as safety issue: No ]
At discharge from the index hospitalization (normal hospitalization is from 3 -4 days.)
All death [ Time Frame: one month ] [ Designated as safety issue: Yes ]
All death [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Cardiac death [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Cardiac death [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Myocardial infarction (MI) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Myocardial infarction (MI) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Composite of death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Composite of death or MI [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Composite of cardiac death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Composite of cardiac death or MI [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: one month ] [ Designated as safety issue: No ]
Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: one month ] [ Designated as safety issue: No ]
Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Stent thrombosis (ARC criteria) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
Stent thrombosis (ARC criteria) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment:	502
Study Start Date:	May 2009
Study Completion Date:	June 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Cypher Sirolimus-eluting stent	Device: Cypher Sirolimus-eluting stent Other Name: Sirolimus-eluting stent
Active Comparator: Endeavor Resolute Zotarolimus-eluting Stent	Device: Endeavor Resolute Zotarolimus-eluting Stent Other Name: Zotarolimus-eluting Stent

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186094

Locations

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

Sponsors and Collaborators

Seung-Jung Park

CardioVascular Research Foundation, Korea

Medtronic

Investigators

Principal Investigator:

Seung-Jung Park, MD, PhD

Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

More Information

No publications provided by CardioVascular Research Foundation, Korea

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:	NCT01186094 History of Changes
Other Study ID Numbers:	2008-0086
Study First Received:	October 18, 2009
Last Updated:	August 6, 2012
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:

Coronary Artery Disease
Stent

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus

Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 22, 2013