Status:
COMPLETED
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: (LONG-DES-IV)
Lead Sponsor:
Seung-Jung Park
Collaborating Sponsors:
CardioVascular Research Foundation, Korea
Medtronic
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 a...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
502 Patients enrolled
Trial Details
Trial ID
NCT01186094
Start Date
May 1 2009
End Date
June 1 2011
Last Update
August 8 2012
Active Locations (12)
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1
Stcarollo Hospital
Suncheon, Cheon-nam, South Korea
2
Konyang University Hospital
Daejeon, Chungcheongnam-do, South Korea
3
Wonju Christian Hospital
Wŏnju, Gangwon-do, South Korea
4
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, South Korea