The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
PCI of de-novo lesions
PCI of de-novo lesions
Klinik für Kardiologie, Angiologie und Konservative Intensivtherapie Klinikum Ernst von Bergmann
Postdam, Brandenburg, Germany
Medizinisches Versorgungszentrum
Hamburg, Germany
Late lumen loss
Late lumen loss = MLD in-lesion initially - MLD in lesion after six months (after nitroglycerin in identical projections); assessment by an independent Core Lab.
Time frame: 6 months
Thrombotic occlusion of the target lesion
Time frame: 30 days, 6, 12, 24, 60 months
Revascularization of the target lesion
Time frame: 30 days, 6, 12, 24, 60 months
Myocardial infarction
Time frame: 30 days, 6, 12, 24, 60 months
Death
Time frame: 30 days, 6, 12, 24, 60 months
Combined clinical endpoint (MACE)
consisting of thrombotic occlusion of the treated segment, target lesion revascularization, myocardial infarction, or death
Time frame: 30 days, 6, 12, 24, 60 months
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