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Post Marketing Clinical Trial to Demonstrate the Performance of the MedHub AutocathFFR Device.

Medhub Ltd. · 2021
ClinicalTrials.gov · Datasets · License: Public Domain · 2021
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Patients with suspected coronary artery disease who are scheduled to undergo a coronary angiography procedure will be enrolled in the study. The angiographic images will be processed by the Medhub Autocath FFR device to generate the Autocath FFR measurement. Based on AMAR approval, MedHub Autocath FFR measurements may be used to determine revascularization in lesions found in the Left Anterior Descending (LAD) coronary artery. Consequently, invasive FFR (using a coronary pressure wire and hyperemic stimulus) is not mandatory for lesions in the LAD, although it is at the discretion of the physician whether or not to perform the invasive FFR procedure. Lesions in the Right Coronary Artery (RCA) and Left Circumflex Coronary (LCX) arteries, when clinically indicated, will be required to undergo an invasive FFR procedure in order to determine revascularization. In these cases, the Autocath FFR measurements will not be used for diagnostic or clinical decisions, but solely as a supportive tool. The MedHub Autocath FFR measurement per vessel will be compared to the invasive FFR measurement in the RCA and LCX lesions and in LAD lesions, for which invasive FFR measurements are available. The dichotomously scored MedHub Autocath FFR per vessel will be compared to the invasive FFR, where an FFR ≤ 0.80 will be considered "positive", while an FFR \> 0.8 will be considered "negative". The sensitivity and specificity of the MedHub Autocath FFR will be calculated.
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