Status:
COMPLETED
The Drift-Reduction for Improved FFR Using Fiberoptic Technology (DRIFT) Study
Lead Sponsor:
Columbia University
Conditions:
Left Anterior Descending Coronary Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 le...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Male or female subjects, \>18 years of age.
- Patients with stable angina, unstable angina or non-ST segment elevation myocardial infarction (if the LAD lesion is the non-culprit lesion) and in whom an intermediate proximal LAD de novo stenosis (30-80%) with TIMI flow 3 has been identified on angiography. Note: Patients with multi-vessel disease can be enrolled.
- Patients have had fractional flow reserve (FFR) and optical coherence tomography (OCT) of the LAD with the OpSens FFR system as part of their routine evaluation as standard of care procedure.
- Provides written, informed consent and HIPAA consent to use the data in a clinical study.
Exclusion
- (General exclusion criteria)
- Patients presented with NSTEMI with the LAD involved as the culprit lesion
- Any ST-elevation myocardial infarction within the past 30 days.
- Hemodynamic instability requiring vasopressor or mechanical circulatory support.
- Prior heart transplant.
- Known left ventricular ejection fraction ≤40%.
- LAD supplying akinetic or severely hypokinetic territories if already known based on prior imaging.
- Patient is enrolled in another clinical study that may impact the results of this study.
- FFR not acquired per instructions for the OpSens Wire.
- LAD Lesion not assessed with OCT.
- (Angiographic exclusion criteria)
- Thrombolysis in Myocardial Infarction (TIMI) grade 2 or lower at baseline angiography.
- Target lesion involves left main (stenosis \>50%).
- Previous percutaneous coronary intervention (PCI) with stent in LAD or left main trunk.
- Presence of chronic total occlusion in any vessel.
- Presence of a side branch≥2.75 mm with ≥70% stenosis in the LAD.
- Bifurcation lesion that resulted in the stent implantation of a side branch.
Key Trial Info
Start Date :
June 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03848650
Start Date
June 19 2018
End Date
May 13 2019
Last Update
June 11 2024
Active Locations (2)
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1
New York Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States, 10032
2
St. Francis Hospital
Roslyn, New York, United States, 11576