Coronary; Ischemic
Conditions
Keywords
Coronary Artery Stenosis, Stenosis, Resting Flow Reserve (RFR), Volcano Verrata Pressure Wire
Brief 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. 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.
Interventions
DEVICEVolcano Verrata Pressure 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.
DEVICESt. Jude Medical (SJM) Aeris Pressure Wire System
The pressure wire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters.
Sponsors
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. Patient provides signed written informed consent before any study-specific procedure. 3. Undergoing coronary angiography, for silent ischemia, stable angina, acute coronary syndrome, or other acceptable indication per the local standard of care. 4. Angiographically 40%-90% stenosis present in at least one native coronary artery. 5. Undergoing physiological assessment for standard clinical or diagnostic indications
Exclusion criteria
1. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left). 2. Left main stenosis 3. Vessel(s) and lesion(s) not amenable for percutaneous coronary intervention (PCI) , for example diffuse disease. 4. Saphenous vein graft, chronic total occlusion 5. Haemodynamic instability at the time of intervention (heart rate\<50 beats per minute, systolic blood pressure \<90mmHg), balloon pump 6. Currently participating in another clinical study that interferes with study results. 7. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. 8. Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results. 9. High degree A-V block, sinus node disease. 10. Asthma/Chronic obstructive pulmonary disease (COPD) with active wheeze 11. Known hypersensitivity to adenosine 12. ST-Elevation Myocardial Infarction (STEMI) within 48 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Agreement Between Mean RFR and iFR Measurements | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Classification (FFR≤/>0.80) by iFR | During procedure | — |
| Pressure Drift of RFR | During procedure | — |
| Pressure Drift of iFR | During procedure | — |
| Lesion Classification (FFR≤/>0.80) by RFR | During procedure | — |
| Measurement Reproducibility for iFR | During procedure | 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. |
| Ability to Advance to the Target Lesion and Measure RFR and iFR | During procedure | Percentage of technical failure due to the inability to deliver the wire and measure out of total number of all procedures |
| Measurement Reproducibility for RFR | During procedure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary 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.
Volcano Verrata Pressure 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 System: The pressure wire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Primary |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Referred for Coronary Angiography | 5 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
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.
Time frame: During procedure
Population: After 5 patients, investigators realized that the standard deviation of the measurements in real life was higher than the calculated difference that could have existed between the two different measurement techniques and therefore did not collect or analyze the data for the 5 subjects (out of a target of 92).
Secondary
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
Time frame: During procedure
Population: After 5 patients, investigators realized that the standard deviation of the measurements in real life was higher than the calculated difference that could have existed between the two different measurement techniques and therefore did not collect or analyze the data for the 5 subjects (out of a target of 92).
Secondary
Lesion Classification (FFR≤/>0.80) by iFR
Time frame: During procedure
Population: After 5 patients, investigators realized that the standard deviation of the measurements in real life was higher than the calculated difference that could have existed between the two different measurement techniques and therefore did not collect or analyze the data for the 5 subjects (out of a target of 92).
Secondary
Lesion Classification (FFR≤/>0.80) by RFR
Time frame: During procedure
Population: After 5 patients, investigators realized that the standard deviation of the measurements in real life was higher than the calculated difference that could have existed between the two different measurement techniques and therefore did not collect or analyze the data for the 5 subjects (out of a target of 92).
Secondary
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.
Time frame: During procedure
Population: After 5 patients, investigators realized that the standard deviation of the measurements in real life was higher than the calculated difference that could have existed between the two different measurement techniques and therefore did not collect or analyze the data for the 5 subjects (out of a target of 92).
Secondary
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.
Time frame: During procedure
Population: After 5 patients, investigators realized that the standard deviation of the measurements in real life was higher than the calculated difference that could have existed between the two different measurement techniques and therefore did not collect or analyze the data for the 5 subjects (out of a target of 92).
Secondary
Pressure Drift of iFR
Time frame: During procedure
Population: Since only 5 out of 92 were treated, data was not systematically collected and analysis was not performed.
Secondary
Pressure Drift of RFR
Time frame: During procedure
Population: After 5 patients, investigators realized that the standard deviation of the measurements in real life was higher than the calculated difference that could have existed between the two different measurement techniques and therefore did not collect or analyze the data for the 5 subjects (out of a target of 92).