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Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-VII: Sirolimus-eluting (Ultimaster) vs. Everolimus-Eluting Stents (Xience)

Not Applicable
Terminated
Conditions
Diseases of the circulatory system
Registration Number
KCT0003063
Lead Sponsor
Asan Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Terminated
Sex
All
Target Recruitment
400
Inclusion Criteria

The patient must be at least 19 years of age.
Significant native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 25mm, which requiring at long stent placement without intervening normal segment.
Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction (NSTEMI)
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 Criteria

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
In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment). However, non-target vessel ISR is permitted.
Patients with EF<30%.
Serum creatinine level = 2.0mg/dL or dependence on dialysis.
Patients with left main stem stenosis (>50% by visual estimate)

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
In-segment late luminal loss
Secondary Outcome Measures
NameTimeMethod
All death;Cardiac death;Myocardial infarction (MI);Composite of death or MI;Composite of cardiac death or MI;Target vessel revascularization (ischemia-driven and clinically-driven);Target lesion revascularization (ischemia-driven and clinically-driven);Target-vessel failure;Stent thrombosis;In-stent late loss;In-stent and in-segment restenosis;Angiographic pattern of restenosis;Volume of intimal hyperplasia;Incidence of late stent malapposition;Procedural success
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