The purpose of the study id to demonstrate an advantage for intra-vascular ultrasound (IVUS) optimized drug-eluting stent (DES) implantation compared to angiography in complex lesions
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
284
Ivus optimised stent implantation
angiographically guided DES implantation
Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group.
Time frame: Procedure day
Target lesion revascularisation (TLR) at 9 months: superiority or statistical trend for the IVUS optimized group
Time frame: 9 months
Major adverse cardiac events (MACE) at 9 months: superiority or statistical trend for the IVUS guided group due to lower TLR and no difference in myocardial infarction (MI) or death.
Time frame: 9 months
MACE events at 2 years.
Time frame: 2 years
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