Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III (LONG-DES-III)
LONG-DES-III
1 other identifier
interventional
451
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 coronary-artery-disease
Started Jun 2008
20 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
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 18, 2009
CompletedFirst Posted
Study publicly available on registry
March 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedAugust 8, 2012
August 1, 2012
2 years
October 18, 2009
August 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In-segment late luminal loss
9 month follow-up
Secondary Outcomes (31)
All Death
one month
Cardiac death
1 year
Myocardial infarction (MI)
1 year
Composite of death or MI
1 year
Composite of cardiac death or MI
1 year
- +26 more secondary outcomes
Study Arms (2)
Cypher
ACTIVE COMPARATORSirolimus-eluting stent
Xience V
ACTIVE COMPARATOREverolimus-eluting stent
Interventions
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 (20)
Sam Anyang Hospital
Anyang, South Korea
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Busan Paik Hospital
Busan, South Korea
St.Mary's Catholic Medical Center
Busan, South Korea
Soonchunhyang University Cheonan Hospital
Cheonan, South Korea
St.Mary's Catholic Medical Center
Cheongju-si, South Korea
Gangwon National University Hospital
Chuncheon, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Asan Medical Center
Gangneung, South Korea
Gwangju Christian Hospital
Gwangju, South Korea
Dongguk University Hospital
Gyongju, South Korea
St.Mary's Catholic Medical Center
Inchon, South Korea
Jeju Hanla Hospital
Jeju City, South Korea
Gyeongsang Uniservity Hospital
Jinju, South Korea
Asan Medical Center
Seoul, South Korea
Hangang Sacred Heart Hospital
Seoul, South Korea
Seoul Veterans Hospital
Seoul, South Korea
St.Mary's Catholic Medical Center
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Ulsan University Hospital
Ulsan, South Korea
Related Publications (1)
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.
PMID: 22017935DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jung Park, MD, PhD
Department of Medicine, 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
October 18, 2009
First Posted
March 2, 2010
Study Start
June 1, 2008
Primary Completion
June 1, 2010
Study Completion
August 1, 2010
Last Updated
August 8, 2012
Record last verified: 2012-08