N/A
N=74
PrEssure wiRe Compared to Microcatheter-based Sensing Technology For the Evaluation of FFR Measurements
Ischemia · Angina
Bottom Line
View on ClinicalTrials.gov: NCT02648230 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Mean Fractional Flow Reserve (FFR) — 0.84; 0.79 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- St. Jude Medical Pressure Wire (Device); ACIST Navvus Microcatheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Fractional Flow Reserve (FFR) |
0.84; 0.79 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 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 significant (>50% visual estimation) stenosis present in at least one native coronary artery.
- Undergoing FFR assessment for standard clinical or diagnostic indications
Exclusion Criteria
- Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
- Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease.
- 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.
- Known hypersensitivity to adenosine
Data sourced from ClinicalTrials.gov (NCT02648230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.