The Drift-Reduction for Improved FFR Using Fiberoptic Technology (DRIFT) Study (NCT03848650) | Clinical Trial Compass
CompletedNot Applicable
The Drift-Reduction for Improved FFR Using Fiberoptic Technology (DRIFT) Study
United States60 participantsStarted 2018-06-19
Plain-language 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 left anterior descending coronary artery (LAD) stenoses in clinical practice.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
(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%).
* Previou…
What they're measuring
1
Percentage of Recordings of Significant Drift in Pre and Post-PCI
Timeframe: During procedure, approximately less than an hour