The purpose of this study is to establish the safety and effectiveness of paclitaxel eluting balloon (SeQuent Please) compared to coronary stenting with the Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) in the treatment of drug eluting stent restenosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
175
Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)
paclitaxel eluting balloon (SeQuent Please)
Asan Medical Center
Seoul, Songpa-gu, South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
Chungbuk National University Hospital
Chungjoo, South Korea
Late luminal loss
Late luminal loss at 9 months angiographic follow-up.
Time frame: 9months
Death
Time frame: 1 year
Myocardial infarction
Time frame: 1 year
Target lesion revascularization
Time frame: 1 year
Target vessel revascularization
Time frame: 1 year
Stent thrombosis
Time frame: 1 year
In-segment or in-stent restenosis at 9 month angiographic follow-up
Time frame: 1 year
Procedural success
defined as achievement of a final diameter stenosis of \<30% by QCA(Quantitative Coronary Angiography) using any percutaneous method, without the occurrence of death, Q wave Myocardial Infarction, or repeat revascularization of the target lesion during the hospital stay. participants will be followed for the duration of hospital stay, an expected average of 3days.
Time frame: 3day
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Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea
Chonnam National University Hospital
Gwangju, South Korea
National Health Insurance Service Ilsan Hospital
Ilsan, South Korea
Dong-A Medical Center
Pusan, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
...and 1 more locations