PrEssure wiRe Compared to Microcatheter-based Sensing Technology For the Evaluation of FFR Measurements

Study Overview
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Brief Summary
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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
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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.

Official Title
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PrEssure wiRe Compared to Microcatheter-based Sensing Technology For the Evaluation of cORonary Fractional Flow Reserve Measurements

Conditions
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Angina, Ischemia

Intervention / Treatment
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* Device: St. Jude Medical Pressure Wire
* Device: ACIST Navvus Microcatheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pressure wire and Microcatheter<br>All subjects enrolled will have both an FFR done measured by a pressure wire (PW) and then again by a microcatheter (MC). | Device: St. Jude Medical Pressure Wire<br>* 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<br>* Other names: PW;Device: ACIST Navvus Microcatheter<br>* 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<br>* Other names: MC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion (an average of an hour) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemia, Fractional Flow Reserve, Stent