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After 5 patients, realized that the standard deviation of the measurements in real life was higher than the calculated difference.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volcano Verrata Pressure Wire | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Classification (FFR≤/>0.80) by RFR | During procedure | |
| Lesion Classification (FFR≤/>0.80) by iFR | During procedure | |
| Pressure Drift of RFR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ajay Kirtane, MD | CUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | During procedure |
|
Day of the procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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 so study halted early and data was not collected and analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ajay Kirtane, MD, SM | Columbia University | 212-305-7060 | akirtane@columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2017 | Jun 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| D023921 | Coronary Stenosis |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
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|
| St. Jude Medical (SJM) Aeris Pressure Wire System | Device | The pressure wire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters. |
|
|
| During procedure |
| Pressure Drift of iFR | 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. | 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. | 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 | During procedure |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Referred for Coronary Angiography | Count of Participants | Participants |
|
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| Secondary | Lesion Classification (FFR≤/>0.80) by RFR | 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). | Posted | During procedure |
|
|
| Secondary | Lesion Classification (FFR≤/>0.80) by iFR | 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). | Posted | During procedure |
|
|
| Secondary | Pressure Drift of RFR | 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). | Posted | During procedure |
|
|
| Secondary | Pressure Drift of iFR | Since only 5 out of 92 were treated, data was not systematically collected and analysis was not performed. | Posted | During procedure |
|
|
| 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. | 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). | Posted | During procedure |
|
|
| 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. | 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). | Posted | During procedure |
|
|
| 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 | 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). | Posted | During procedure |
|
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D020763 | Pathological Conditions, Anatomical |