Novel Adenosine-independent Index of Coronary Artery Stenosis Severity Resting Flow Reserve (RFR)
Primary Purpose
Coronary; Ischemic
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Volcano Verrata Pressure Wire
St. Jude Medical (SJM) Aeris Pressure Wire System
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary; Ischemic focused on measuring Coronary Artery Stenosis, Stenosis, Resting Flow Reserve (RFR), Volcano Verrata Pressure Wire
Eligibility Criteria
Inclusion Criteria:
- Age β₯ 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
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Columbia University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Primary
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Lesion Classification (FFRβ€/>0.80) by RFR
Lesion Classification (FFRβ€/>0.80) by iFR
Pressure Drift of RFR
Pressure Drift of iFR
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.
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.
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
Full Information
NCT ID
NCT03461705
First Posted
February 22, 2018
Last Updated
January 28, 2020
Sponsor
Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT03461705
Brief Title
Novel Adenosine-independent Index of Coronary Artery Stenosis Severity Resting Flow Reserve
Acronym
RFR
Official Title
Derivation and Validation of a Novel Adenosine-independent Index of Coronary Artery Stenosis Severity Resting Flow Reserve
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
After 5 patients, realized that the standard deviation of the measurements in real life was higher than the calculated difference.
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
August 2, 2018 (Actual)
Study Completion Date
August 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary; Ischemic
Keywords
Coronary Artery Stenosis, Stenosis, Resting Flow Reserve (RFR), Volcano Verrata Pressure Wire
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Volcano Verrata Pressure Wire
Other Intervention Name(s)
iFR Wire
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
St. Jude Medical (SJM) Aeris Pressure Wire System
Other Intervention Name(s)
RFR Wire
Intervention Description
The pressure wire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters.
Primary Outcome Measure Information:
Title
Percentage Agreement Between Mean RFR and iFR Measurements
Description
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
Secondary Outcome Measure Information:
Title
Lesion Classification (FFRβ€/>0.80) by RFR
Time Frame
During procedure
Title
Lesion Classification (FFRβ€/>0.80) by iFR
Time Frame
During procedure
Title
Pressure Drift of RFR
Time Frame
During procedure
Title
Pressure Drift of iFR
Time Frame
During procedure
Title
Measurement Reproducibility for RFR
Description
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
Title
Measurement Reproducibility for iFR
Description
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
Title
Ability to Advance to the Target Lesion and Measure RFR and iFR
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age β₯ 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
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajay Kirtane, MD
Organizational Affiliation
CUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Novel Adenosine-independent Index of Coronary Artery Stenosis Severity Resting Flow Reserve
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