The propose of this study is to demonstrate, whenever using Drug Eluting Stent is not possible, the clinical security at 12 months, of the combinaison Bare Metal Stent plus Drug Eluting Balloon.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Enrollment
500
All patients are treated with the PRO-Kinetic Energy Stent and Pantera Lux drug eluting balloon for the last post dilatation.
Chu Toulouse
Toulouse, France
Target Lesion Failure (TLF) at 12 months.
TLF is defined as a composite of cardiac death, any target vessel myocardial infarction (MI), urgent coronary artery bypass graft (CABG) and clinically driven target lesion revascularization (TLR).
Time frame: 12 months
Target Lesion Failure
Time frame: 1 and 6 months
Bleeding rate according to BARC definition
Time frame: 1, 6 and 12 months
Clinically driven target vessel revascularization
Time frame: 1, 6 and 12 months
MACCE
Cardiac death, stroke, myocardial infarction (Q wave and non Q wave) and TVR by non planned angioplasty or bypass graft
Time frame: 1, 6 and 12 months
All deaths
Time frame: 1, 6 and 12 months
Myocardial Infarction (MI) (Q wave and non Q wave)
Time frame: 1, 6 and 12 months
Definite incidence of stent thrombosis
Time frame: 1, 6 and 12 months
Clinically driven target lesion revascularization
Time frame: 1, 6 and 12 months
Target lesion failure for patients >/= 80 years
Time frame: 1, 6 and 12 months
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Bleeding rate according to BARC definition for patients >/= 80 years
Time frame: 1, 6 and 12 months
Target lesion failure for kidney failure patients (clearance < 30 ml/ min)
Time frame: 1, 6 and 12 months
Bleeding Rate according to BARC definition for kidney failure patients (clearance < 30 ml/ min)
Time frame: 1, 6 and 12 months