Left Anterior Descending Coronary Artery Stenosis Clinical Trial
Official title:
The Drift-Reduction for Improved Fractional Flow Reserve (FFR) Using Fiberoptic Technology (DRIFT) Study
The primary objective of this study is to assess the accuracy, efficacy, and durability of the OpSens Medical OptoWire Deux pressure wire in the assessment of angiographically intermediate proximal left anterior descending coronary artery (LAD) stenoses in clinical practice.
This study is designed as a prospective, observational in nature, multi-center, single-arm, clinical registry to estimate the ischemic burden of angiographically intermediate proximal LAD stenosis in clinical practice using the OpSens Medical OptoWire Deux FFR system. Subjects with stable angina or unstable angina who are found to have an intermediate proximal LAD stenosis on coronary angiography with anatomy amenable to PCI and underwent physiological lesion assessment with the OptoWire Deux pressure wire and OCT as part of their routine procedures using standard of care techniques will be enrolled. Patients meeting enrollment criteria will be offered the opportunity to enroll in this observational registry post-procedure. All patients enrolled in this study are expected to be evaluated and treated using a standard of care technique. This study will enroll a total of 60 patients at Columbia University Medical Center and St. Francis Hospital. ;
| Status | Clinical Trial | Phase | |
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| Recruiting |
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