Left Anterior Descending Coronary Artery StenosisOPSENSNCT03848650
The Drift-Reduction for Improved FFR Using Fiberoptic Technology (DRIFT) Study
A study testing OpSens Medical OptoWire and FFR in people with Left Anterior Descending Coronary Artery Stenosis, run by Columbia University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Anterior Descending Coronary Artery Stenosis
- What is being tested?
- OpSens Medical OptoWire and FFR
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Jun 2018to 13 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- (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%.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York Presbyterian Hospital/Columbia University Medical Center
New York, New York, 10032
St. Francis Hospital
Roslyn, New York, 11576
About this study
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.
Read the 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.
- Being tested
- OpSens Medical OptoWire, FFR
- Keywords
- FFR OCT LAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpSens Medical OptoWireDevice
Also called OpSens Medical OptoWire Deux FFR System
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.
FFRProcedure or surgery
Also called Fractional Flow Reserve
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).
| Study group | Role | What they receive |
|---|---|---|
| Opsens Medical OptoWire | Experimental | Subjects who will have or recently had FFR using the Opsens Medical OptoWire Deux FFR system. Receives: Device: OpSens Medical OptoWire; Procedure: FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During procedure, approximately less than an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start19 Jun 2018
- Primary completion13 May 2019
- Study completion13 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Left Anterior Descending Coronary Artery StenosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manish Parikh, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848650
- Sponsor's protocol ID
- AAAR7661
- Acronym
- OPSENS
- Status last verified
- Jun 2024
- First submitted
- 19 Feb 2019
- Last updated
- 11 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not plan to share individual participant data (IPD) with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Drift-Reduction for Improved Fractional Flow Reserve (FFR) Using Fiberoptic Technology (DRIFT) Study
- ClinicalTrials.gov ID
- NCT03848650
- Acronym / sponsor ID
- OPSENS / AAAR7661
- Keywords
- FFR OCT LAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Posted 11 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opsens Medical OptoWire | Experimental | Device: OpSens Medical OptoWire, Procedure: FFRSubjects who will have or recently had FFR using the Opsens Medical OptoWire Deux FFR system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OpSens Medical OptoWireAlso: OpSens Medical OptoWire Deux FFR SystemThe 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. | Device | Opsens Medical OptoWire |
| FFRAlso: Fractional Flow ReserveA 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). | Procedure or surgery | Opsens Medical OptoWire |
Primary outcome
Percentage of Recordings of Significant Drift in Pre and Post-PCI
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data (IPD) with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manish Parikh, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OpSens Medical OptoWire and FFR in people with Left Anterior Descending Coronary Artery Stenosis, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Recordings of Significant Drift in Pre and Post-PCI (time frame: During procedure, approximately less than an hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.