Observational Study of OCT in a Patients Undergoing FFR (ILUMIEN I)
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|ClinicalTrials.gov Identifier: NCT01663896|
Recruitment Status : Completed
First Posted : August 13, 2012
Results First Posted : July 2, 2020
Last Update Posted : July 2, 2020
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Device: OCT stent guidance|
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|
|Actual Enrollment :||418 participants|
|Official Title:||Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)|
|Actual Study Start Date :||December 11, 2012|
|Actual Primary Completion Date :||March 12, 2015|
|Actual Study Completion Date :||October 2015|
Single or multi vessel disease
Pre- and post-PCI fractional flow reserve (FFR) and OCT were performed in participants.
Device: OCT stent guidance
Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT
- Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting [ Time Frame: In-hospital until discharge ]Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes in-hospital.
- Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting [ Time Frame: 30 Days ]Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 30 days
- Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) [ Time Frame: 12 months ]Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months
- Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT [ Time Frame: 1 Year ]
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663896