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| Name | Class |
|---|---|
| CRF | UNKNOWN |
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This is a prospective, observational, multi-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.
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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 and have an invasive FFR measurement with vasodilation in at least one coronary artery. Each subject will undergo both the standard invasive FFR and the investigational FFRangio.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| Columbia University Medical Center/NewYork Presbyterian Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30586699 | Derived | Fearon WF, Achenbach S, Engstrom T, Assali A, Shlofmitz R, Jeremias A, Fournier S, Kirtane AJ, Kornowski R, Greenberg G, Jubeh R, Kolansky DM, McAndrew T, Dressler O, Maehara A, Matsumura M, Leon MB, De Bruyne B; FAST-FFR Study Investigators. Accuracy of Fractional Flow Reserve Derived From Coronary Angiography. Circulation. 2019 Jan 22;139(4):477-484. doi: 10.1161/CIRCULATIONAHA.118.037350. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 6, 2023 | |
| Reset | Nov 21, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 6, 2023 | Nov 21, 2023 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 1 hour |
| Sensitivity and specificity of the dichotomously scored FFRangio measured index per lesion as measured by the site. | 1 hour |
| Device Success | The ratio of produced FFRangio values from all FFRangio measurements that were started. | 1 hour |
| Usability of FFRangio | A questionnaire will be completed by the user to assess how easy the system is for use and how intuitive it is. | 1 hour |
| Comprehensiveness of the FFRangio User Manual in providing adequate instructions | A questionnaire will be completed to measure if the user understands the main parts of the software instructions after reading the Instructions for use. | 1 hour |
| Procedure related Adverse and Serious Adverse Events | 1 hour |
| Device related Adverse and Serious Adverse Events | 1 hour |
| New York |
| New York |
| 10032 |
| United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104-6061 | United States |
| OLV Ziekenhuis | Aalst | 9300 | Belgium |
| Rigs Hospital CPH | Copenhagen | 2100 | Denmark |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| HaSharon Hospital | Petah Tikva | 49100 | Israel |
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |