Trial Outcomes & Findings for Novel Adenosine-independent Index of Coronary Artery Stenosis Severity Resting Flow Reserve (NCT NCT03461705)
NCT ID: NCT03461705
Last Updated: 2020-02-07
Results Overview
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.
TERMINATED
NA
5 participants
During procedure
2020-02-07
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Novel Adenosine-independent Index of Coronary Artery Stenosis Severity Resting Flow Reserve
Baseline characteristics by cohort
| Measure |
Primary
n=5 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
|
Referred for Coronary Angiography
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During procedurePopulation: 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).
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During procedurePopulation: 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During procedurePopulation: 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During procedurePopulation: 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During procedurePopulation: Since only 5 out of 92 were treated, data was not systematically collected and analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During procedurePopulation: 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).
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During procedurePopulation: 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).
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During procedurePopulation: 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).
Percentage of technical failure due to the inability to deliver the wire and measure out of total number of all procedures
Outcome measures
Outcome data not reported
Adverse Events
Primary
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place