Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III (LONG-DES-III)
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01078038
- Lead Sponsor
- Seung-Jung Park
- 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.
- 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 III trial inclusion and exclusion criteria will be randomized 1:1 to a) sirolimus-eluting and b) everolimus-eluting stent by the stratified randomization method.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 451
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method In-segment late luminal loss 9 month follow-up
- Secondary Outcome Measures
Name Time Method All Death one year Cardiac death 9 months Myocardial infarction (MI) 9 months Composite of death or MI 9 months Composite of cardiac death or MI 9 months Target vessel revascularization (ischemia-driven and clinically-driven) 9 months Target lesion revascularization (ischemia-driven and clinically-driven) 9 months Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) 1 year Stent thrombosis (ARC criteria) 9 months In-stent late loss at 9 month angiographic follow-up at 9 month angiographic follow-up In-stent and in-segment restenosis at 9 month angiographic follow-up at 9 month angiographic follow-up Angiographic pattern of restenosis at 9 month angiographic follow-up at 9 month angiographic follow-up Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study) at 9 month angiographic follow-up Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study) at 9 month angiographic follow-up Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay. 3 days in average At discharge from the index hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days.
Trial Locations
- Locations (16)
Sam Anyang Hospital
🇰🇷Anyang, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Bucheon, Korea, Republic of
Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
St.Mary's Catholic Medical Center
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Cheonan Hospital
🇰🇷Cheonan, Korea, Republic of
Gangwon National University Hospital
🇰🇷Chuncheon, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Gwangju Christian Hospital
🇰🇷Gwangju, Korea, Republic of
Dongguk University Hospital
🇰🇷Gyongju, Korea, Republic of
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