Clinical trial NCT01186120: Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents for Long-Coronary Lesions
Official title: Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-V:Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: coronary disease
stent
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2010-08-23
Enrollment: 500
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 biolimus A9-eluting stent (Nobori) vs. everolimus-eluting stent (Promus Element) 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 V trial inclusion and exclusion criteria will be randomized 1:1 to a) NOBORI and b) PROMUS-ELEMENT 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 angiographic follow-up
Secondary outcomes:
measure: Death (all-cause and cardiac)
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 1 year
measure: stent thrombosis(ARC criteria)
timeFrame: 1 year
measure: target-lesion revascularization
timeFrame: 1 year
measure: target-vessel revascularization
timeFrame: 1 year
measure: Procedural success
timeFrame: at 1 day
measure: Death (all-cause and cardiac)
timeFrame: one month
measure: Death (all-cause and cardiac)
timeFrame: 9 months
measure: Myocardial infarction
timeFrame: one month
measure: Myocardial infarction
timeFrame: 9 months
measure: Composite of death or MI
timeFrame: one month
measure: Composite of death or MI
timeFrame: 9 months
measure: Composite of death or MI
timeFrame: 1 year
measure: Composite of cardiac death or MI
timeFrame: one month
measure: Composite of cardiac death or MI
timeFrame: 9 months
measure: Composite of cardiac death or MI
timeFrame: 1 year
measure: target-lesion revascularization
timeFrame: one month
measure: target-lesion revascularization
timeFrame: 9 months
measure: target-vessel revascularization
timeFrame: one month
measure: target-vessel revascularization
timeFrame: 9 months
measure: stent thrombosis(ARC criteria)
timeFrame: one month
measure: stent thrombosis(ARC criteria)
timeFrame: 9 months
measure: In-stent late loss
timeFrame: 9 month angiographic follow-up
measure: 8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)
timeFrame: 12 months
measure: In-stent and in-segment restenosis
timeFrame: 9 month angiographic follow-up
measure: Angiographic pattern of restenosis
timeFrame: 9 month angiographic follow-up
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Hospital, Buchen
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Cheonan Hospital
city: Chooncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Ilsan
country: Korea, Republic of
facility: NHIC Ilsan Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A University Medical Center
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Catholic University, Kangnam St. Mary's Hospital
Study officials:
affiliation: Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
name: Seung-Jung Park, MD.,PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang DY, Jang JS, Chang M, Lee CH, Lee PH, Ahn JM, Lee SW, Kim YH, Park SW, Park DW, Park SJ; LONG-DES Investigators. Comparison of Different Types of Drug-Eluting Stents for De Novo Long Coronary Artery Lesions. JACC Asia. 2022 May 24;2(4):446-456. doi: 10.1016/j.jacasi.2022.02.009. eCollection 2022 Aug.
citation: Lee JY, Park DW, Kim YH, Ahn JM, Kim WJ, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Yang TH, Lee BK, Lee NH, Yang JY, Shin WY, Park HS, Kim KS, Hur SH, Lee SY, Park JS, Choi YS, Lee SU, Her SH, Park SJ. Comparison of biolimus A9-eluting (Nobori) and everolimus-eluting (Promus Element) stents in patients with de novo native long coronary artery lesions: a randomized Long Drug-Eluting Stent V trial. Circ Cardiovasc Interv. 2014 Jun;7(3):322-9. doi: 10.1161/CIRCINTERVENTIONS.113.000841. Epub 2014 May 13.