Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: (LONG-DES-IV)
- Conditions
- Coronary Artery Disease
- Interventions
- Device: CypherDevice: Endeavor Resolute
- Registration Number
- NCT01186094
- Lead Sponsor
- Seung-Jung Park
- 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 and eligible for LONG-DES IV trial inclusion and exclusion criteria will be randomized 1:1 to a) CYPHER and b) ENDEAVOR RESOLUTE stent by the stratified randomization method.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 502
- 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
- Arm && Interventions
Group Intervention Description Cypher Cypher Sirolimus-eluting stent Endeavor Resolute Endeavor Resolute Zotarolimus-eluting Stent
- Primary Outcome Measures
Name Time Method In-segment late luminal loss 9 month follow-up
- Secondary Outcome Measures
Name Time Method All Death 1 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) 12 months 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. at 3 days in average At discharge from the index hospitalization (normal hospitalization is from 3 -4 days.)
All death 9 months
Trial Locations
- Locations (12)
Inje University Ilsan Paik Hospital
🇰🇷Ilsan, Gyeong-gi, Korea, Republic of
Kyung Hee University Medical Hospital
🇰🇷Seoul, Korea, Republic of
Gangwon National University Hospital
🇰🇷Chuncheon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Cheonan Hospital
🇰🇷Cheonan, Korea, Republic of
Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Kyung-book, Korea, Republic of
Wonju Christian Hospital
🇰🇷Wonju, Kangwon, Korea, Republic of
Dong-A University Medical Center
🇰🇷Busan, Korea, Republic of
Stcarollo Hospital
🇰🇷Suncheon, Cheon-nam, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Gyeong-gi, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Chungnam, Korea, Republic of