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

NCT04724057 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 488

Last updated 2021-04-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

AutocathFFR

The MedHub Autocath FFR device is a software only medical device. The FFR is computed from several standard DICOM format 2D angiography images retrieved from the C-arm imaging system, which display the structure of the vessels. The MedHub AutocathFFR device software analyzes these images and automatically (without the need for user selection or markings) and computes and displays the FFR on the viewed blood vessel.

Sponsors & Collaborators

  • Medhub Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2021-06-01
Completion
2021-08-01
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04724057 on ClinicalTrials.gov