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

This study has been completed.
Sponsor:
Collaborators:
CardioVascular Research Foundation, Korea
Medtronic
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01186094
First received: October 18, 2009
Last updated: August 6, 2012
Last verified: August 2012

October 18, 2009
August 6, 2012
May 2009
April 2011   (final data collection date for primary outcome measure)
In-segment late luminal loss [ Time Frame: 9 month follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01186094 on ClinicalTrials.gov Archive Site
  • 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 ]
  • All Death [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (MI) [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: No ]
  • Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (ARC criteria) [ Time Frame: 30 days, 6 months, and 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 30 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: Cypher
    Sirolimus-eluting stent
    Other Name: Sirolimus-eluting stent
  • Device: Endeavor Resolute
    Zotarolimus-eluting Stent
    Other Name: Zotarolimus-eluting Stent
  • Active Comparator: Cypher
    Sirolimus-eluting stent
    Intervention: Device: Cypher
  • Active Comparator: Endeavor Resolute
    Zotarolimus-eluting Stent
    Intervention: Device: Endeavor Resolute
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
502
June 2011
April 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01186094
2008-0086
Yes
Seung-Jung Park, CardioVascular Research Foundation, Korea
Seung-Jung Park
  • CardioVascular Research Foundation, Korea
  • Medtronic
Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
CardioVascular Research Foundation, Korea
August 2012

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