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Pivotal, Single-arm Clinical Trial to Assess the Efficacy and Safety of the MedHub AutocathFFR Software Device

NCT04861519 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 308

Last updated 2024-03-26

No results posted yet for this study

Summary

Prospective (analysis of retrospective data), multi-center, observational, single-arm study. This structure was selected as the "worst case" due to the fact that it represents real life usage of invasive FFR measurement is performed mostly in "gray zone" cases, which are that their severity cannot be determined intuitively and based on the physician eyeball. By using real-world historical data of invasive FFR, the analysis of the obtained data can ensure that the study results are expected to include invasive FFR results that are in the grey zone, when invasive FFR is used in real life and represent the real expected use of the product. Furthermore, the analysis of the data obtained in the studies with these similar devices measuring FFR obtained from angiograms was actually performed in a retrospective manner. That is, although the angiographic images and pressure wire recordings were obtained in real-time, due to the need to mark the vessel in real-time and obtain specific projections during the procedure without which the FFR cannot be calculated, the primary endpoint (sensitivity and specificity) and accuracy were determined in all studies by a post-hoc review by a similar independent QCA core laboratory. The invasive FFR data, as well as the software generated FFR data were reviewed post-hoc by a core laboratory or even at the company.

Conditions

  • Stable Angina
  • Unstable Angina
  • NSTEMI

Interventions

OTHER

Collecting invasive FFR measurements.

Invasive FFR measurements from the patient's hospital records will be collected.

Sponsors & Collaborators

  • Medhub Ltd.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-09
Primary Completion
2021-10-30
Completion
2021-12-31

Countries

  • Israel

Study Locations

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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 NCT04861519 on ClinicalTrials.gov