This study compares angiographic and clinical outcomes in patients with long coronary lesions treated with sirolimus-eluting stent (Ultimaster stent) or everolimus-eluting stent (Xience Alpine stent). The study uses a randomized, multicenter, controlled design approach.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Percutaneous coronary intervention with Ultimaster stent for long lesion
Percutaneous coronary intervention with Xience alpine stent for long lesion
Gangwon National Univ. Hospital
Chuncheon, South Korea
Asan Medical Center
Seoul, South Korea
In-segment late luminal loss
Time frame: 13-month
All death
Time frame: 1 year
Cardiac death
Time frame: 1 year
Myocardial infarction (MI)
Time frame: 1 year
Composite of death or MI
Time frame: 1 year
Composite of cardiac death or MI
Time frame: 1 year
Target vessel revascularization (ischemia-driven and clinically-driven)
Time frame: 1 year
Target lesion revascularization (ischemia-driven and clinically-driven)
Time frame: 1 year
Target-vessel failure
death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization
Time frame: 1 year
Stent thrombosis
Time frame: 1 year
In-stent late loss
In-stent late loss at 13-month angiographic follow-up
Time frame: 13-month
In-stent and in-segment restenosis
In-stent and in-segment restenosis at 13-month angiographic follow-up
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Time frame: 13-month
Angiographic pattern of restenosis
Angiographic pattern of restenosis at 13 -month angiographic follow-up
Time frame: 13-month
Volume of intimal hyperplasia
Volume of intimal hyperplasia at 13-month IVUS follow-up (sub-study)
Time frame: 13-month
Incidence of late stent malapposition
Incidence of late stent malapposition at 13-month IVUS follow-up (sub-study)
Time frame: 13-month
Procedural success
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.
Time frame: 5 days