Coronary Artery Disease Clinical Trial
Official title:
OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON (OPINION)
The aim of this randomized study is to evaluate the impact of Optical frequency domain imaging (OFDI) guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with Intravascular ultrasound (IVUS) guidance.
Optical frequency domain imaging (OFDI) is a novel, high resolution intravascular imaging
modality. Intravascular ultrasound (IVUS) is a widely used conventional imaging modality for
achieving optimal stent deployment.
The aim of this randomized study is to evaluate the impact of OFDI guidance for Percutaneous
Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with IVUS guidance.
We will enroll 800 patients with a de novo lesion who will undergo PCI with DES as is
routine practice. Patients will be rondomely assigned to either OFDI-guided PCI arm or
IVUS-guided PCI arm.
Patients will then have a follow-up contact at the time of hospital discharge, 8 month and
12 month after PCI.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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