Left Anterior Descending Coronary Artery Stenosis
Conditions
Keywords
FFR OCT LAD
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 left anterior descending coronary artery (LAD) stenoses in clinical practice.
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 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.
Interventions
DEVICEOpSens Medical OptoWire
The OptoWire is FDA approved to measure pressure in coronary vessels during diagnostic angiography and coronary interventions. The OptoWire Deux pressure wire (OpSens Medical, Quebec, Canada) is a novel technology utilizing optical coherence technology to enhance FFR assessment of the coronaries.
PROCEDUREFFR
A guide wire-based procedure that can accurately measure blood pressure and flow through a specific part of the coronary artery. FFR is done through a standard diagnostic catheter at the time of a coronary angiogram (a.k.a. cardiac catheterization).
Sponsors
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Recordings of Significant Drift in Pre and Post-PCI | During procedure, approximately less than an hour | The rate of significant drift is defined as FFR \<0.97 or \>1.03 with the in the pre-percutaneous coronary intervention (PCI) FFR recording using the OpSens OptoWire Deux pressure wire system. FFR is calculated by measuring the ratio between pressure distal to a stenosis and pressure proximally to stenosis using specialized pressure-measuring guidewires during maximal hyperemia. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Opsens Medical OptoWire Subjects who will have or recently had FFR using the Opsens Medical OptoWire Deux FFR system.
OpSens Medical OptoWire: The OptoWire is FDA approved to measure pressure in coronary vessels during diagnostic angiography and coronary interventions.
The OptoWire Deux pressure wire (OpSens Medical, Quebec, Canada) is a novel technology utilizing optical coherence technology to enhance FFR assessment of the coronaries.
FFR: A guide wire-based procedure that can accurately measure blood pressure and flow through a specific part of the coronary artery. FFR is done through a standard diagnostic catheter at the time of a coronary angiogram (a.k.a. cardiac catheterization). | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Opsens Medical OptoWire | — |
|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 8.7 | — |
| Hypertension | 45 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 60 participants | — |
| Sex: Female, Male Female | 18 Participants | — |
| Sex: Female, Male Male | 42 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Percentage of Recordings of Significant Drift in Pre and Post-PCI
The rate of significant drift is defined as FFR \<0.97 or \>1.03 with the in the pre-percutaneous coronary intervention (PCI) FFR recording using the OpSens OptoWire Deux pressure wire system. FFR is calculated by measuring the ratio between pressure distal to a stenosis and pressure proximally to stenosis using specialized pressure-measuring guidewires during maximal hyperemia.
Time frame: During procedure, approximately less than an hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Opsens Medical OptoWire | Percentage of Recordings of Significant Drift in Pre and Post-PCI | 5.8 Percentage |