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

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ClinicalTrials.gov Identifier: NCT01078038
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : August 8, 2012
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

Tracking Information
First Submitted Date  ICMJE October 18, 2009
First Posted Date  ICMJE March 2, 2010
Last Update Posted Date August 8, 2012
Study Start Date  ICMJE June 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2010)
In-segment late luminal loss [ Time Frame: 9 month follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01078038 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2011)
  • All Death [ Time Frame: one month ]
  • Cardiac death [ Time Frame: 1 year ]
  • Myocardial infarction (MI) [ Time Frame: 1 year ]
  • Composite of death or MI [ Time Frame: 1 year ]
  • Composite of cardiac death or MI [ Time Frame: 1 year ]
  • Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: 1 year ]
  • Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: 1 year ]
  • Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) [ Time Frame: 1 year ]
  • Stent thrombosis (ARC criteria) [ Time Frame: 1 year ]
  • In-stent late loss at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ]
  • In-stent and in-segment restenosis at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ]
  • Angiographic pattern of restenosis at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ]
  • Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study) [ Time Frame: at 9 month angiographic follow-up ]
  • Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study) [ Time Frame: at 9 month angiographic follow-up ]
  • 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: 3 days in average ]
    At discharge from the index hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days.
  • All Death [ Time Frame: 9 months ]
  • All Death [ Time Frame: one year ]
  • Cardiac death [ Time Frame: one month ]
  • Cardiac death [ Time Frame: 9 months ]
  • Myocardial infarction (MI) [ Time Frame: one month ]
  • Myocardial infarction (MI) [ Time Frame: 9 months ]
  • Composite of death or MI [ Time Frame: one month ]
  • Composite of death or MI [ Time Frame: 9 months ]
  • Composite of cardiac death or MI [ Time Frame: one month ]
  • Composite of cardiac death or MI [ Time Frame: 9 months ]
  • Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: one month ]
  • Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: 9 months ]
  • Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: one month ]
  • Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: 9 months ]
  • Stent thrombosis (ARC criteria) [ Time Frame: one month ]
  • Stent thrombosis (ARC criteria) [ Time Frame: 9 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2010)
  • All Death [ Time Frame: In-hospital, 30 days, 6 months, and 1 year ]
  • Cardiac death [ Time Frame: In-hospital, 30 days, 6 months, and 1 year ]
  • Myocardial infarction (MI) [ Time Frame: In-hospital, 30 days, 6 months, and 1 year ]
  • Composite of death or MI [ Time Frame: In-hospital, 30 days, 6 months, and 1 year ]
  • Composite of cardiac death or MI [ Time Frame: In-hospital, 30 days, 6 months, and 1 year ]
  • Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: In-hospital, 30 days, 6 months, and 1 year ]
  • Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: In-hospital, 30 days, 6 months, and 1 year ]
  • Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) at 12 month clinical follow-up [ Time Frame: In-hospital, 30 days, 6 months, and 1 year ]
  • Stent thrombosis (ARC criteria) [ Time Frame: In-hospital, 30 days, 6 months, and 1 year ]
  • In-stent late loss at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ]
  • In-stent and in-segment restenosis at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ]
  • Angiographic pattern of restenosis at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ]
  • Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study) [ Time Frame: at 9 month angiographic follow-up ]
  • Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study) [ Time Frame: at 9 month angiographic follow-up ]
  • 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: In-hospital ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III (LONG-DES-III)
Official Title  ICMJE Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III: Sirolimus vs. Everolimus-eluting Stent
Brief Summary This randomized study is a multi-center, randomized, study to compare the efficacy of sirolimus versus everolimus-eluting stent implantation for long coronary lesions.
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 III trial inclusion and exclusion criteria will be randomized 1:1 to a) sirolimus-eluting and b) everolimus-eluting stent by the stratified randomization method.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Device: Cypher
    Sirolimus-eluting stent implantation
    Other Name: Sirolimus-eluting stent
  • Device: Xience V
    Everolimus-eluting Stent implantation
    Other Name: Everolimus-eluting Stent
Study Arms  ICMJE
  • Active Comparator: Cypher
    Sirolimus-eluting stent
    Intervention: Device: Cypher
  • Active Comparator: Xience V
    Everolimus-eluting stent
    Intervention: Device: Xience V
Publications * Park DW, Kim YH, Song HG, Ahn JM, Kim WJ, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Seung KB, Yang TH, Lee SG, Lee JH, Seong IW, Cheong SS, Lee BK, Lee NH, Lee SW, Lee SW, Lee K, Kim HS, Jeon DS, Kim MK, Nah DY, Tahk SJ, Park SJ. Comparison of everolimus- and sirolimus-eluting stents in patients with long coronary artery lesions: a randomized LONG-DES-III (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III) Trial. JACC Cardiovasc Interv. 2011 Oct;4(10):1096-103. doi: 10.1016/j.jcin.2011.05.024.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2011)
451
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2010)
500
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01078038
Other Study ID Numbers  ICMJE 2008-0250
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seung-Jung Park, CardioVascular Research Foundation, Korea
Study Sponsor  ICMJE Seung-Jung Park
Collaborators  ICMJE CardioVascular Research Foundation, Korea
Investigators  ICMJE
Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
PRS Account CardioVascular Research Foundation, Korea
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP