Angina, Ischemia
Conditions
Keywords
Ischemia, Fractional Flow Reserve, Stent
Brief summary
The model by which physicians measure the lack of blood flow in the vessels that supply blood to the heart muscle is called Fractional Flow Reserve (FFR). FFR is the measurement of the pressure across the vessels that supply blood to the heart. These are known as the coronary arteries. This study involves comparing two FFR wires, the St. Jude Medical Pressure Wire (PW) and the ACIST Navvus Microcatheter (MC) to check the accuracy of the devices. FFR allows real-time estimation of the effects of a narrowed vessel, whereas standard angiography can underestimate or overestimate narrowing, because it only visualizes contrast (the different areas of color) inside a vessel.
Detailed description
Fractional flow reserve (FFR) measurement by pressure wire (PW) 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 a microcatheter (MC)-based sensor measurement of fractional flow reserve has been introduced. Small scale in-vivo comparisons have been performed suggesting the utility of this approach to measure FFR,but these data are limited and have not been independently validated. This non-randomized, prospective study is designed to evaluate the accuracy of MC-based FFR measurement to the PW standard in lesions subjected to FFR assessment in routine clinical practice.
Interventions
DEVICESt. 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
DEVICEACIST 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
Sponsors
Abbott Medical Devices
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 significant (\>50% visual estimation) stenosis present in at least one native coronary artery. 5. Undergoing FFR 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. Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease. 3. Currently participating in another clinical study that interferes with study results. 4. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. 5. Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results. 6. High degree A-V block, sinus node disease. 7. Known hypersensitivity to adenosine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Fractional Flow Reserve (FFR) | 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. |
Countries
United States
Participant flow
Recruitment details
Enrolled between December 2015 to December 2016.
Participants by arm
| Arm | Count |
|---|---|
| Pressure Wire and Microcatheter 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 | 74 |
| Total | 74 |
Baseline characteristics
| Characteristic | Pressure Wire and Microcatheter |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 42 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 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 | 27 Participants |
| Race (NIH/OMB) White | 38 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 74 |
| other Total, other adverse events | 0 / 74 |
| serious Total, serious adverse events | 0 / 74 |
Outcome results
Primary
Mean Fractional Flow Reserve (FFR)
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.
Time frame: Through study completion (an average of an hour)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Pressure Wire and Microcatheter | Mean Fractional Flow Reserve (FFR) | Pressure Wire | 0.84 ratio |
| Pressure Wire and Microcatheter | Mean Fractional Flow Reserve (FFR) | Pressure Catheter (microcatheter) | 0.79 ratio |