Fractional Flow Reserve Fax Registry

NCT03055910 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2017-02-16

No results posted yet for this study

Summary

The Fractional Flow Reserve Fax Registry is an investigator-initiated, real-world registry to analyze the use of fractional flow reserve (FFR) measurements in clinical practice in cardiac catheterization laboratories in Germany. The registry aims to collect the data of 2000 patients who underwent FFR recordings for clinical reasons. The main outcome parameter is the frequency of coronary revascularization following FFR. Secondary outcome parameters include the distribution of quantitative FFR results in clinical practice, the influence of intracoronary versus intravenous adenosine on the distribution of FFR results, the rate of complications as a result of FFR measurements, the average number of FFR wires needed per patient. Since the study will include a large number of patients who undergo i.c. administration of adenosine and a large number of patients who undergo i.v. administration of adenosine, it will be possible to analyze whether the route of adenosine administration is an independent predictor of the FFR result.

Conditions

Interventions

DIAGNOSTIC_TEST

Fractional Flow Reserve Measurement

Wire-based invasive measurement of the fractional flow reserve in the context of coronary angiography and percutaneous coronary intervention in order to assess the hemodynamic relevance of coronary artery stenoses

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY
  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Stephan Achenbach, MD · Friedrich Alexander University Erlangen-Nuremberg

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Germany

Study Locations

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Entities

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 NCT03055910 on ClinicalTrials.gov