An interventional study of OpSens Medical OptoWire and FFR in Left Anterior Descending Coronary Artery Stenosis, sponsored by Columbia University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by Columbia University · Not applicable, Interventional, and Other
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.
302 studies on the registry are indexed under Coronary Stenosis; 63 are open to participants now.
This study's enrollment of 60 is below the median of 200 across 160 interventional studies indexed under Coronary Stenosis.
Browse Coronary Stenosis studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
(General exclusion criteria)
(Angiographic exclusion criteria)
Subjects who will have or recently had FFR using the Opsens Medical OptoWire Deux FFR system.
Device: OpSens Medical OptoWire · Procedure: FFR
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.
Also known as: OpSens Medical OptoWire Deux FFR System
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).
Also known as: Fractional Flow Reserve
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
| Milestone | Opsens Medical OptoWire |
|---|---|
| Started | 60 |
| Completed | 60 |
| Not completed | 0 |
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.
| Percentage | Opsens Medical OptoWire |
|---|---|
| Percentage of Recordings of Significant Drift in Pre and Post-PCI | 5.8 |
Collected over During procedure, approximately up to 1 hour. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Opsens Medical OptoWire | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Age, Continuous(years) | Opsens Medical OptoWire |
|---|---|
| Mean | 65 ± 8.7 |
| Sex: Female, Male(Participants) | Opsens Medical OptoWire |
|---|---|
| Female | 18 |
| Male | 42 |
| Race and Ethnicity Not Collected(Participants) | Opsens Medical OptoWire |
|---|
| Region of Enrollment(participants) | Opsens Medical OptoWire |
|---|---|
| United States | 60 |
| Hypertension(Participants) | Opsens Medical OptoWire |
|---|---|
| Count of participants | 45 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — We do not plan to share individual participant data (IPD) with other researchers.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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