Clinical trial NCT01186094: Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: (LONG-DES-IV)
Official title: Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: Sirolimus vs. Zotarolimus-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
name: Medtronic
First posted: 2010-08-23
Enrollment: 502
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 (Cypher) versus zotarolimus-eluting stent (Endeavor Resolute) 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 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 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: 1 year
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: 12 months
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: at 3 days in average
measure: All death
timeFrame: one month
measure: All death
timeFrame: 9 months
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: Suncheon
country: Korea, Republic of
facility: Stcarollo Hospital
state: Cheon-nam
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
state: Chungnam
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
state: Gyeong-gi
city: Ilsan
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeong-gi
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
state: Kangwon
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
state: Kyung-book
city: Busan
country: Korea, Republic of
facility: Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Cheonan Hospital
city: Chuncheon
country: Korea, Republic of
facility: Gangwon National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical 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: 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.