The purpose of this study is to examine the safety and effectiveness of coronary stenting with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic patients.
Prospective, randomized multi-center trial of 300 patients will be enrolled at 7 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis \>50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Cilotax stent vs. b) Xience Prime stent. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
291
everolimus-eluting stent implantation
paclitaxel with cilostazol dual drug eluting stent implantation
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
In-segment late luminal loss
Time frame: at 9 month angiographic follow-up
All Death
Time frame: 12 months
Cardiac death
Time frame: 12 months
Myocardial infarction
Time frame: 12 months
Target vessel revascularization (ischemia-driven)
Time frame: 12 months
Target lesion revascularization (ischemia-driven)
Time frame: 12 months
Stent thrombosis (by ARC definition)
Time frame: 12 months
Binary restenosis in both in-stent and in-segment
Time frame: at 9 month angiographic follow-up
Angiographic pattern of restenosis
Time frame: at 9 month angiographic follow-up
Procedural success
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: At discharge from the index hospitalization, an expected average of 3 days.
All Death
Time frame: 1 month
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The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea
Gangneung Asan Hospital
Gangneung, South Korea
Inje University Pusan Paik Hospital
Pusan, South Korea
Asan Medical Center
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
All Death
Time frame: 4 months
All Death
Time frame: 9 months
Cardiac death
Time frame: 1 month
Cardiac death
Time frame: 4 months
Cardiac death
Time frame: 9 months
Myocardial infarction
Time frame: 1 month
Myocardial infarction
Time frame: 4 months
Myocardial infarction
Time frame: 9 months
Target vessel revascularization (ischemia-driven)
Time frame: 1 month
Target vessel revascularization (ischemia-driven)
Time frame: 4 months
Target vessel revascularization (ischemia-driven)
Time frame: 9 months
Target lesion revascularization (ischemia-driven)
Time frame: 1 month
Target lesion revascularization (ischemia-driven)
Time frame: 4 months
Target lesion revascularization (ischemia-driven)
Time frame: 9 months
Stent thrombosis (by ARC definition)
Time frame: 1 month
Stent thrombosis (by ARC definition)
Time frame: 4 months
Stent thrombosis (by ARC definition)
Time frame: 9 months