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This is a prospective, observational, single-center, single-arm, clinical trial designed to assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to Invasive FFR for diagnosing hemodynamically significant coronary stenosis in Multi-Vessel Disease.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFRangio | Device | FFRangio is a non-invasive image-based software device that provides physicians with a quantitative analysis of functional significance of the coronary lesion, similar to invasive FFR (Fractional Flow Reserve), and a qualitative three-dimensional model of the demonstrated coronary arteries, during routine PCI procedure. The CathWorks FFRangio software device is able to perform all required processing and calculations, based only on angiography images and hemodynamics information that are acquired during the coronary catheterization procedure. The CathWorks FFRangioTM technology does not require any additional use of invasive devices, or any additional vasodilation treatment, as required by other known FFR techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of the dichotomously scored FFRangio measured index compared to invasive FFR | Sensitivity and specificity of the dichotomously scored FFRangio measured index per vessel as compared with invasively-derived FFR; Index ≤ 0.80 is scored "positive" while Index > 0.8 is negative. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Continuously scored FFR (FFRangio and Invasive FFR). | Regression of FFRangio on continuous FFR, with slope, intercept and the correlation coefficient. | 1 hour |
| Accuracy, Positive predictive value and negative predictive value per vessel and per lesion |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with stable angina, unstable angina or NSTEMI who are referred to coronary angiography, have multi-vessel coronary artery disease and have an invasive FFR measurement at two lesions at minimum. Each subject will undergo both the standard invasive FFRs and the investigational FFRangio.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gifu Heart Center | Gifu | 500-8384 | Japan |
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| 1 hour |