Coronary Artery Disease Clinical Trial
Official title:
Late Incomplete Stent Apposition Evaluation II: Vascular Effects Evaluation After Polimer and No-polimer Based Coronary Artery Drug Eluting Stent Ilmplantation. An IVUS Based Study
Vascular effects evaluation after non-polimeric and polimeric paclitaxel stent
implantation.In particular the investigators will use Taxus )as a polimeric stent)and Axxion
(as a non-polimeirc)stent system. The investigators will look at late stent malapposition by
means of intracoronary ultrasound imaging technique (IVUS) at baseline and 9 months
follow-up. The investigators sought to compare the two stent types with the same drug to
verify the polimer role. The polimer itself seems to provoke inflammation and
hypersensibility if the arterial wall and it seems to be the base of a process of positive
remodeling found at drug eluting stent implantation site.
This positive remodeling is the mechanism producing late stent malapposition which on its
turn can determine stent thrombosis, as demonstrated by pathological studies. At the same
time the investigators will study the incidence of clinical events like myocardial
infarction, stent thrombosis, TLR and death along with the incidence of angiographic
restenosis at 2 years follow up.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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