Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-VII: Sirolimus-eluting (Ultimaster) vs. Everolimus-Eluting Stents (Xience)
- 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
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.
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
Name Time Method In-segment late luminal loss
- Secondary Outcome Measures
Name Time Method 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