Stable Coronary Artery Disease Clinical Trial
Official title:
Role of Computed Tomography Coronary Angiography in Optimalization of Percutaneous Coronary Interventions With Stent Implantation.
The purpose of the study is to determine whether results of the computed tomography coronary angiography may be helpful in planning and performing percutaneous angioplasty in patients with stable angina pectoris.
Currently most percutaneous coronary interventions (PCI) are planned and performed on the
basis of invasive coronary angiography which provides the information that is confined to
the vessel lumen. This limitation may be partially responsible for the unfavorable long term
outcome and complications that occur in some patients. Additional information on the disease
burden in angiographically normal coronary segments adjacent to the lesion site could impact
the treatment strategy and clinical results. Imaging modalities that allow not only lumen
but also vessel wall assessment include both invasive (e.g. intravascular ultrasounds -
IVUS) and non-invasive (e.g. multislice computed tomography - MSCT) methods. IVUS guidance
of the coronary interventions is expensive and given its invasiveness is related to the
additional risk. The number of patients who are referred for coronary angiography with
significant stenosis diagnosed with MSCT is rapidly increasing. Most interventional
cardiologists are not familiar with coronary vessel images produced by MSCT. The aim of our
study is to assess if the analyses of MSCT images before the PCI may impact the treatment
strategy and immediate results. The study will enroll subjects with significant coronary
stenosis diagnosed with MSCT who are referred to the catheterisation laboratory for invasive
angiography and PCI. The study participants will be randomized into two groups:
Group 1 - the results of MSCT are analysed by the interventional cardiologist that is to
perform angiography and PCI. Based on this analysis preliminary procedural strategy is
planned (stent diameters, decision on direct stenting vs. predilatation, decision on
postdilation) Group 2 - interventional cardiologist is blinded to the images obtained by
MSCT. The PCI procedure is performed solely on the basis of invasive coronary angiography In
both study groups IVUS will be performed before and after stent implantation. The operator
will be blinded to the results of pre-PCI IVUS. The second IVUS will be performed when
angiographic results are optimal in the opinion of the operator. The results of the second
IVUS examination will be the efficacy measure of the two compared treatment strategies.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
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