Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: (LONG-DES-IV)
LONG-DES-IV
1 other identifier
interventional
502
1 country
12
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.
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 May 2009
12 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
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 18, 2009
CompletedFirst Posted
Study publicly available on registry
August 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedAugust 8, 2012
August 1, 2012
1.9 years
October 18, 2009
August 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In-segment late luminal loss
9 month follow-up
Secondary Outcomes (31)
All Death
1 year
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
Endeavor Resolute
ACTIVE COMPARATORZotarolimus-eluting Stent
Interventions
Zotarolimus-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
- Medtroniccollaborator
Study Sites (12)
Stcarollo Hospital
Suncheon, Cheon-nam, South Korea
Konyang University Hospital
Daejeon, Chungcheongnam-do, South Korea
Wonju Christian Hospital
Wŏnju, Gangwon-do, South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, South Korea
Inje University Ilsan Paik Hospital
Ilsan, Gyeonggi-do, South Korea
Yeungnam University Medical Center
Daegu, Kyung-book, South Korea
Busan Paik Hospital
Busan, South Korea
Dong-A University Medical Center
Busan, South Korea
Soonchunhyang University Cheonan Hospital
Cheonan, South Korea
Gangwon National University Hospital
Chuncheon, South Korea
Asan Medical Center
Seoul, South Korea
Kyung Hee University Medical Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 23048051DERIVED
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
August 23, 2010
Study Start
May 1, 2009
Primary Completion
April 1, 2011
Study Completion
June 1, 2011
Last Updated
August 8, 2012
Record last verified: 2012-08