To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty
Following angiography, patients with focal DES restenosis (lesion length ≤ 10mm) with diameter stenosis \>50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for PCI without any exclusion criteria will be randomized 1:1 to: a) Cypher stent vs. b) Cutting balloon angioplasty. All patients will be followed for 1 year. Angiographic follow-up at 9-months is mandatory.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Cutting balloon
Sirolimus-eluting stent
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Choeng Ju St.Mary's Hospital
Choeng Ju, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
Binary In-segment Restenosis
Time frame: At 9 months angiographic follow-up
Composite end-point of death, myocardial infarction, or target vessel revascularization
Time frame: At 9-month after index procedure
Stent thrombosis
Time frame: In-hospital, 30 days, 9 months, and 1year
Late luminal loss
Time frame: at 8 month angiographic follow-up
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
Time frame: during the hospital stay
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