Clinical trial NCT01078038: Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III (LONG-DES-III)
Official title: Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III: Sirolimus vs. Everolimus-eluting Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Stent
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2010-03-02
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: In-segment late luminal loss
timeFrame: 9 month follow-up
Secondary outcomes:
measure: All Death
timeFrame: one month
measure: Cardiac death
timeFrame: 1 year
measure: Myocardial infarction (MI)
timeFrame: 1 year
measure: Composite of death or MI
timeFrame: 1 year
measure: Composite of cardiac death or MI
timeFrame: 1 year
measure: Target vessel revascularization (ischemia-driven and clinically-driven)
timeFrame: 1 year
measure: Target lesion revascularization (ischemia-driven and clinically-driven)
timeFrame: 1 year
measure: Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)
timeFrame: 1 year
measure: Stent thrombosis (ARC criteria)
timeFrame: 1 year
measure: In-stent late loss at 9 month angiographic follow-up
timeFrame: at 9 month angiographic follow-up
measure: In-stent and in-segment restenosis at 9 month angiographic follow-up
timeFrame: at 9 month angiographic follow-up
measure: Angiographic pattern of restenosis at 9 month angiographic follow-up
timeFrame: at 9 month angiographic follow-up
measure: Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study)
timeFrame: at 9 month angiographic follow-up
measure: Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study)
timeFrame: at 9 month angiographic follow-up
measure: 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.
timeFrame: 3 days in average
measure: All Death
timeFrame: 9 months
measure: All Death
timeFrame: one year
measure: Cardiac death
timeFrame: one month
measure: Cardiac death
timeFrame: 9 months
measure: Myocardial infarction (MI)
timeFrame: one month
measure: Myocardial infarction (MI)
timeFrame: 9 months
measure: Composite of death or MI
timeFrame: one month
measure: Composite of death or MI
timeFrame: 9 months
measure: Composite of cardiac death or MI
timeFrame: one month
measure: Composite of cardiac death or MI
timeFrame: 9 months
measure: Target vessel revascularization (ischemia-driven and clinically-driven)
timeFrame: one month
measure: Target vessel revascularization (ischemia-driven and clinically-driven)
timeFrame: 9 months
measure: Target lesion revascularization (ischemia-driven and clinically-driven)
timeFrame: one month
measure: Target lesion revascularization (ischemia-driven and clinically-driven)
timeFrame: 9 months
measure: Stent thrombosis (ARC criteria)
timeFrame: one month
measure: Stent thrombosis (ARC criteria)
timeFrame: 9 months
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Sam Anyang Hospital
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Busan
country: Korea, Republic of
facility: Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: St.Mary's Catholic Medical Center
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Cheonan Hospital
city: Cheongju
country: Korea, Republic of
facility: St.Mary's Catholic Medical Center
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: GangNeung
country: Korea, Republic of
facility: Asan Medical Center
city: Gwangju
country: Korea, Republic of
facility: Gwangju Christian Hospital
city: Gyongju
country: Korea, Republic of
facility: Dongguk University Hospital
city: Inchon
country: Korea, Republic of
facility: St.Mary's Catholic Medical Center
city: Jeju
country: Korea, Republic of
facility: Jeju Hanla Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang Uniservity Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hangang Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Veterans Hospital
city: Seoul
country: Korea, Republic of
facility: St.Mary's Catholic Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.