NCT01663896

Observational Study of OCT in a Patients Undergoing FFR

Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 418 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	OCT stent guidance	Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT

Timeline

• Start date: 2012-12-11
• Primary completion: 2015-03-12
• Completion: 2015-10-01
• First posted: 2012-08-13
• Last updated: 2020-07-02
• Results posted: 2020-07-02

Locations

36 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, China, Czechia, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom