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The ADAPT Study: Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease

NCT04828590 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 302

Last updated 2022-04-22

No results posted yet for this study

Summary

DEEPVESSEL FFR is a medical device that is designed to extract three- dimensional coronary tree structures and generate computed tomography-derived fraction flow reserve (FFR) values from coronary CT angiogram images. The primary objective of this multi-center clinical validation study is to validate the clinical performance of DEEPVESSEL FFR in identifying patients with myocardial ischemia due to significant obstructive coronary artery diseases.

Conditions

Interventions

OTHER

No intervention

Due to observational study

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER

  • Keya Medical

    lead INDUSTRY

Principal Investigators

  • Joseph Schoepf, MD · Medical University of South Carolina

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-10
Primary Completion
2021-12-01
Completion
2021-12-31
FDA Device
Yes

Countries

  • United States
  • Austria
  • France
  • Italy
  • Poland

Study Locations

More Related Trials

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 NCT04828590 on ClinicalTrials.gov