Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents for Long-Coronary Lesions
LONG-DES-V
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-V:Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents
1 other identifier
interventional
500
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Aug 2010
Typical duration for phase_4 coronary-artery-disease
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 18, 2010
CompletedFirst Posted
Study publicly available on registry
August 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedNovember 6, 2013
November 1, 2013
2.8 years
August 18, 2010
November 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In-segment late luminal loss
9 month angiographic follow-up
Secondary Outcomes (26)
Death (all-cause and cardiac)
1 year
Myocardial infarction
1 year
stent thrombosis(ARC criteria)
1 year
target-lesion revascularization
1 year
target-vessel revascularization
1 year
- +21 more secondary outcomes
Study Arms (2)
Biolimus A9-eluting stent
EXPERIMENTALNOBORI stent
Everolimus-eluting stent
ACTIVE COMPARATORPROMUS ELEMENTE stent
Interventions
drug-eluting stent
drug-eluting stent
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
Study Sites (11)
Soonchunhyang University Hospital, Buchen
Bucheon-si, South Korea
Soonchunhyang University Cheonan Hospital
Cheonan, South Korea
Kangwon National University Hospital
Chooncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Kyungpook National University Hospital
Daegu, South Korea
NHIC Ilsan Hospital
Ilsan, South Korea
Dong-A University Medical Center
Pusan, South Korea
Inje University Pusan Paik Hospital
Pusan, South Korea
Asan Medical Center
Seoul, South Korea
Catholic University, Kangnam St. Mary's Hospital
Seoul, South Korea
Related Publications (2)
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.
PMID: 36339368DERIVEDLee 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.
PMID: 24823426DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jung Park, MD.,PhD.
Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
Study Record Dates
First Submitted
August 18, 2010
First Posted
August 23, 2010
Study Start
August 1, 2010
Primary Completion
May 1, 2013
Study Completion
August 1, 2013
Last Updated
November 6, 2013
Record last verified: 2013-11