Coronary; IschemicRFRNCT03461705
Novel Adenosine-independent Index of Coronary Artery Stenosis Severity Resting Flow Reserve
A study testing Volcano Verrata Pressure Wire and St. Jude Medical (SJM) Aeris Pressure Wire System in people with Coronary; Ischemic, run by Columbia University at 1 site in United States.
Trial summary
This study will enroll patients who are referred for coronary angiography and require physiological assessment to see if the lesion can be treated as per the local standard of care. Approximately 92 participants will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary; Ischemic
- What is being tested?
- Volcano Verrata Pressure Wire and St. Jude Medical (SJM) Aeris Pressure Wire System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2017to 2 Aug 2018
- 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
- Age ≥ 18 years.
- Patient provides signed written informed consent before any study-specific procedure.
- Undergoing coronary angiography, for silent ischemia, stable angina, acute coronary syndrome, or other acceptable indication per the local standard of care.
- Angiographically 40%-90% stenosis present in at least one native coronary artery.
- Undergoing physiological assessment for standard clinical or diagnostic indications
Who cannot join
- Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
- Left main stenosis
- Vessel(s) and lesion(s) not amenable for percutaneous coronary intervention (PCI) , for example diffuse disease.
- Saphenous vein graft, chronic total occlusion
- Haemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg), balloon pump
- Currently participating in another clinical study that interferes with study results.
Show all 12Show fewer
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
- Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results.
- High degree A-V block, sinus node disease.
- Asthma/Chronic obstructive pulmonary disease (COPD) with active wheeze
- Known hypersensitivity to adenosine
- ST-Elevation Myocardial Infarction (STEMI) within 48 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Derivation and Validation of a Novel Adenosine-independent Index of Coronary Artery Stenosis Severity Resting Flow Reserve
This study will enroll patients who are referred for coronary angiography and require physiological assessment to see if the lesion can be treated as per the local standard of care. Approximately 92 participants will be enrolled. There are no follow up visits required so participation in this study will end when subjects are discharged from the hospital.The study will be comparing the resting flow reserve against the instantaneous wave-free ratio (iFR) and fractional flow reserve. All these tests offer a way to image a legion and determine if it is suitable to be treated. FFR measures the pressure differences across (narrowed coronary arteries usually due to atherosclerosis), iFR's are performed during cardiac catheterisation (angiography) using invasive coronary pressure wires which are placed in the arteries of the heart that are to be assessed and the Resting flow reserve looks at the maximum increase in blood flow through the coronary arteries above the normal resting volume.
Read the detailed description
Fractional flow reserve (FFR) measurement by under hyperemic conditions has become the invasive gold standard for determining the physiologic extent of cardiac ischemia, and which has been validated in several clinical outcomes studies as a way of optimizing case selection for percutaneous coronary intervention (PCI). More recently in two large-scale randomized controlled trials using a non-hyperemic resting measurement, the instantaneous wave free ratio (iFR) showed non-inferiority in major adverse cardiovascular events (MACE) comparing iFR to FFR for physiological assessment of moderate coronary stenosis. FFR is calculated as the ratio of the distal coronary pressure to the aortic pressure (Pd/Pa) during maximal micro-circulatory relaxation. iFR is a diagnostic tool used to assess whether a stenosis is causing a limitation of blood flow in coronary arteries with subsequent ischemia. iFR is performed during cardiac catheterization (angiography) using invasive coronary pressure wires which are placed in the coronary arteries that are to be assessed. The iFR negates the time averaging and administration of vasodilators necessary for FFR by identifying from the resting pressure waveform a period when the native microcirculatory resistance is constant and minimized in diastole. The study is looking at the accuracy and precision of a novel adenosine-independent index of coronary artery stenosis, the resting flow reserve, against the instantaneous wave-free ratio and fractional flow reserve.
- Conditions
- Coronary; Ischemic
- Being tested
- Volcano Verrata Pressure Wire, St. Jude Medical (SJM) Aeris Pressure Wire System
- Keywords
- Coronary Artery Stenosis, Stenosis, Resting Flow Reserve (RFR), Volcano Verrata Pressure Wire
- Medical subject headings
- Ischemia, Coronary Stenosis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volcano Verrata Pressure WireDevice
Also called iFR Wire
Steerable guidewire with a pressure transducer mounted 3cm proximal to the tip. The guidewire has a diameter of 0.014".
and is packaged preconnected to the connector with a torque device to facilitate navigation through the vasculature.
St. Jude Medical (SJM) Aeris Pressure Wire SystemDevice
Also called RFR Wire
The pressure wire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters.
| Study group | Role | What they receive |
|---|---|---|
| Primary | Experimental | All patients who are referred for coronary angiography and require physiological assessment of intermediate lesions will have both RFR and iFR measured during their standard of care procedure. Both the RFR wire (St. Jude Medical (SJM) Aeris Pressure Wire System) and iFR (Volcano Verrata Pressure Wire) wire will be advanced across the lesion with the sensor located at least 3 cm distal from the lesion. Receives: Device: Volcano Verrata Pressure Wire; Device: St. Jude Medical (SJM) Aeris Pressure Wire System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Agreement Between Mean RFR and iFR Measurements
Mean RFR measurements will be compared against mean iFR measurements to determine if there is an agreement between RFR and iFR for detection of ischemia.
Measured: During procedure
Secondary outcomes (7)
Lesion Classification (FFR≤/>0.80) by RFR
Measured: During procedure
Lesion Classification (FFR≤/>0.80) by iFR
Measured: During procedure
Pressure Drift of RFR
Measured: During procedure
Pressure Drift of iFR
Measured: During procedure
Measurement Reproducibility for RFR
Reproducibility of RFR will be tested against iFR. Reproducibility will be measured by comparing the measure of RFR (minimal ratio of distal coronary pressure/aortic pressure) at time point 1 versus time point 2 against iFR (minimal ratio of distal coronary pressure/aortic pressure during the wave-free period of diastole) at time point 1 versus time point 2.
Measured: During procedure
Measurement Reproducibility for iFR
Reproducibility of iFR will be tested against RFR. Reproducibility will be measured by comparing the measure of iFR (minimal ratio of distal coronary pressure/aortic pressure during the wave-free period of diastole) at time point 1 versus time point 2 against RFR (minimal ratio of distal coronary pressure/aortic pressure) at time point 1 versus time point 2.
Measured: During procedure
Ability to Advance to the Target Lesion and Measure RFR and iFR
Percentage of technical failure due to the inability to deliver the wire and measure out of total number of all procedures
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start20 Oct 2017
- Primary completion2 Aug 2018
- Study completion2 Aug 2018
Why it stopped: After 5 patients, realized that the standard deviation of the measurements in real life was higher than the calculated difference.
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 Coronary; IschemicStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ajay Kirtane, Columbia University
- Investigators
- Ajay Kirtane, MD, Principal investigator, CUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461705
- Sponsor's protocol ID
- AAAR4732
- Acronym
- RFR
- Status last verified
- Jan 2020
- First submitted
- 22 Feb 2018
- Last updated
- 7 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Derivation and Validation of a Novel Adenosine-independent Index of Coronary Artery Stenosis Severity Resting Flow Reserve
- ClinicalTrials.gov ID
- NCT03461705
- Acronym / sponsor ID
- RFR / AAAR4732
- Conditions
- Coronary; Ischemic
- Keywords
- Coronary Artery Stenosis, Stenosis, Resting Flow Reserve (RFR), Volcano Verrata Pressure Wire
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After 5 patients, realized that the standard deviation of the measurements in real life was higher than the calculated difference.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Posted 7 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll patients who are referred for coronary angiography and require physiological assessment to see if the lesion can be treated as per the local standard of care. Approximately 92 participants will be enrolled. There are no follow up visits required so participation in this study will end when subjects are discharged from the hospital.The study will be comparing the resting flow reserve against the instantaneous wave-free ratio (iFR) and fractional flow reserve. All these tests offer a way to image a legion and determine if it is suitable to be treated. FFR measures the pressure differences across (narrowed coronary arteries usually due to atherosclerosis), iFR's are performed during cardiac catheterisation (angiography) using invasive coronary pressure wires which are placed in the arteries of the heart that are to be assessed and the Resting flow reserve looks at the maximum increase in blood flow through the coronary arteries above the normal resting volume.
Detailed description
Fractional flow reserve (FFR) measurement by under hyperemic conditions has become the invasive gold standard for determining the physiologic extent of cardiac ischemia, and which has been validated in several clinical outcomes studies as a way of optimizing case selection for percutaneous coronary intervention (PCI). More recently in two large-scale randomized controlled trials using a non-hyperemic resting measurement, the instantaneous wave free ratio (iFR) showed non-inferiority in major adverse cardiovascular events (MACE) comparing iFR to FFR for physiological assessment of moderate coronary stenosis. FFR is calculated as the ratio of the distal coronary pressure to the aortic pressure (Pd/Pa) during maximal micro-circulatory relaxation. iFR is a diagnostic tool used to assess whether a stenosis is causing a limitation of blood flow in coronary arteries with subsequent ischemia. iFR is performed during cardiac catheterization (angiography) using invasive coronary pressure wires which are placed in the coronary arteries that are to be assessed. The iFR negates the time averaging and administration of vasodilators necessary for FFR by identifying from the resting pressure waveform a period when the native microcirculatory resistance is constant and minimized in diastole. The study is looking at the accuracy and precision of a novel adenosine-independent index of coronary artery stenosis, the resting flow reserve, against the instantaneous wave-free ratio and fractional flow reserve.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary | Experimental | Device: Volcano Verrata Pressure Wire, Device: St. Jude Medical (SJM) Aeris Pressure Wire SystemAll patients who are referred for coronary angiography and require physiological assessment of intermediate lesions will have both RFR and iFR measured during their standard of care procedure. Both the RFR wire (St. Jude Medical (SJM) Aeris Pressure Wire System) and iFR (Volcano Verrata Pressure Wire) wire will be advanced across the lesion with the sensor located at least 3 cm distal from the lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Patient provides signed written informed consent before any study-specific procedure.
- Undergoing coronary angiography, for silent ischemia, stable angina, acute coronary syndrome, or other acceptable indication per the local standard of care.
- Angiographically 40%-90% stenosis present in at least one native coronary artery.
- Undergoing physiological assessment for standard clinical or diagnostic indications
Key exclusion criteria (12 listed)
- Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
- Left main stenosis
- Vessel(s) and lesion(s) not amenable for percutaneous coronary intervention (PCI) , for example diffuse disease.
- Saphenous vein graft, chronic total occlusion
- Haemodynamic instability at the time of intervention (heart rate<50 beats per minute, systolic blood pressure <90mmHg), balloon pump
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 |
|---|---|---|
| Volcano Verrata Pressure WireAlso: iFR WireSteerable guidewire with a pressure transducer mounted 3cm proximal to the tip. The guidewire has a diameter of 0.014". and is packaged preconnected to the connector with a torque device to facilitate navigation through the vasculature. | Device | Primary |
| St. Jude Medical (SJM) Aeris Pressure Wire SystemAlso: RFR WireThe pressure wire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters. | Device | Primary |
Primary outcome
Percentage Agreement Between Mean RFR and iFR Measurements
Time frame: During procedure
Mean RFR measurements will be compared against mean iFR measurements to determine if there is an agreement between RFR and iFR for detection of ischemia.
7 secondary outcomes
Lesion Classification (FFR≤/>0.80) by RFR
Time frame: During procedure
Lesion Classification (FFR≤/>0.80) by iFR
Time frame: During procedure
Pressure Drift of RFR
Time frame: During procedure
Pressure Drift of iFR
Time frame: During procedure
Measurement Reproducibility for RFR
Time frame: During procedure
Measurement Reproducibility for iFR
Time frame: During procedure
Ability to Advance to the Target Lesion and Measure RFR and iFR
Time frame: During procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ajay Kirtane, MD principal investigator
CUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volcano Verrata Pressure Wire and St. Jude Medical (SJM) Aeris Pressure Wire System in people with Coronary; Ischemic, run by Columbia University at 1 site 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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 7 Feb 2020). 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 Agreement Between Mean RFR and iFR Measurements (time frame: During procedure). 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 7 Feb 2020.