The purpose of this study is to define and evaluate optical coherence tomography (OCT) stent guidance parameters through prospective data collection in percutaneous coronary intervention (PCI) procedures of de novo lesions.
Optical coherence tomography (OCT) is an imaging modality that uses near-infrared light to produce high resolution, real-time images that are clearer and more quickly produced than those produced by intravascular ultrasound (IVUS). OCT imaging is performed utilizing an imaging catheter with a single optical fiber core that both emits light and records its reflection while simultaneously rotating 360° during continuous pullback within the coronary artery. Fractional Flow Reserve (FFR) is a pressure-derived, lesion-specific, physiological index determining the hemodynamic severity of intracoronary lesions. FFR is measured by placing a pressure guidewire across the lesion of interest and pharmacologically inducing hyperemia. The ratio of distal to proximal pressure allows the physician to physiologically determine if the narrowing is the cause of ischemia. the goal of this study is to define new parameters for stent optimization, benefitting from the unique Fourier-domain (FD-OCT) capabilities. This stage I study will identify the parameters which will be prospectively tested in a second stage II protocol. In hospital, 30 day, and 12 month outcomes data will be correlated with OCT baseline findings in order to identify optimal stent implant parameters.
Study Type
OBSERVATIONAL
Enrollment
418
Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes in-hospital.
Time frame: In-hospital until discharge
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 30 days
Time frame: 30 Days
Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months
Time frame: 12 months
Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT
Assessment of OCT on Physician Decision Making includes: * Frequency of changes in treatment strategy based on OCT parameter real time assessment vs. angiographic assessment * OCT parameters as assessed by Core Lab
Time frame: 1 Year
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