PrEssure wiRe Compared to Microcatheter-based Sensing Technology For the Evaluation of FFR Measurements
| Status: | Recruiting |
|---|---|
| Conditions: | Angina, Angina, Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/29/2016 |
| Start Date: | October 2015 |
| End Date: | October 2017 |
| Contact: | Ajay Kirtane, MD |
| Email: | ak189@cumc.columbia.edu |
| Phone: | 212 305 7060 |
PrEssure wiRe Compared to Microcatheter-based Sensing Technology For the Evaluation of cORonary Fractional Flow Reserve Measurements
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.
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.
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 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.
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 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.
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
We found this trial at
1
site
116th St and Broadway
New York, New York 10027
New York, New York 10027
(212) 854-1754
Phone: 212-305-7060
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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