Trial Outcomes & Findings for PrEssure wiRe Compared to Microcatheter-based Sensing Technology For the Evaluation of FFR Measurements (NCT NCT02648230)
NCT ID: NCT02648230
Last Updated: 2019-06-14
Results Overview
The mean FFR will be measured with the pressure catheter (PC) to be compared against the mean FFR measured with a standard Pressure Wire (PW) within the same subject across the same target lesion at the same time. Fractional flow reserve measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery.
COMPLETED
NA
74 participants
Through study completion (an average of an hour)
2019-06-14
Participant Flow
Enrolled between December 2015 to December 2016.
Participant milestones
| Measure |
Pressure Wire and Microcatheter
All subjects enrolled will have both a fractional flow reserve (FFR) done measured by a pressure wire (PW) and then again by a microcatheter (MC).
St. Jude Medical Pressure Wire: FFR measurement will be obtained with a PW with the FFR measurement obtained by using a MC within the same subject across the same target lesion at the same time
ACIST Navvus Microcatheter: FFR measurement will be obtained with a MC with the FFR measurement obtained by using a PW within the same subject across the same target lesion at the same time
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
COMPLETED
|
74
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PrEssure wiRe Compared to Microcatheter-based Sensing Technology For the Evaluation of FFR Measurements
Baseline characteristics by cohort
| Measure |
Pressure Wire and Microcatheter
n=74 Participants
All subjects enrolled will have both an FFR done measured by a pressure wire (PW) and then again by a microcatheter (MC).
St. Jude Medical Pressure Wire: FFR measurement will be obtained with a PW with the FFR measurement obtained by using a MC within the same subject across the same target lesion at the same time
ACIST Navvus Microcatheter: FFR measurement will be obtained with a MC with the FFR measurement obtained by using a PW within the same subject across the same target lesion at the same time
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=93 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 11 • n=93 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Through study completion (an average of an hour)The mean FFR will be measured with the pressure catheter (PC) to be compared against the mean FFR measured with a standard Pressure Wire (PW) within the same subject across the same target lesion at the same time. Fractional flow reserve measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery.
Outcome measures
| Measure |
Pressure Wire and Microcatheter
n=74 Participants
All subjects enrolled will have both an FFR done measured by a pressure wire (PW) and then again by a microcatheter (MC).
St. Jude Medical Pressure Wire: FFR measurement will be obtained with a PW with the FFR measurement obtained by using a MC within the same subject across the same target lesion at the same time
ACIST Navvus Microcatheter: FFR measurement will be obtained with a MC with the FFR measurement obtained by using a PW within the same subject across the same target lesion at the same time
|
|---|---|
|
Mean Fractional Flow Reserve (FFR)
Pressure Wire
|
0.84 ratio
Interval 0.78 to 0.89
|
|
Mean Fractional Flow Reserve (FFR)
Pressure Catheter (microcatheter)
|
0.79 ratio
Interval 0.73 to 0.85
|
Adverse Events
Pressure Wire and Microcatheter
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