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Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease

NCT01835808 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 918

Last updated 2015-05-25

No results posted yet for this study

Summary

Functional evaluation of coronary lesions, through the evaluation of fractional flow reserve (FFR) with pressure-wire in patients with coronary artery disease (CAD) was evaluated in a randomised trial - the FAME trial - where it was showed to be superior to classic anatomical evaluation. Based on these results, current guidelines recommend the use of FFR (class I-A recommendation) when objective evidence of vessel-related ischemia is not available. Since the FAME trial was published, FFR use increased dramatically in most European countries, Portugal being no exception to this trend. FFR is currently being used in many interventional cardiology centres quite beyond the European Guidelines recommendation, since many physicians now trust more on the information they can collect with pressure-wire during the angiography, and less on non invasive imaging stress tests.

Considering this widespread use of FFR in the evaluation of patients with CAD, there is a need to clarify the clinical results of this approach in a "real patient setting". The Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease (POST-IT) was planned to evaluate if the use of FFR in the decision of coronary revascularization is feasible and allows optimized clinical results in "real world" non selected patients, as showed in clinical randomised trials.

Conditions

Interventions

DEVICE

Fractional flow reserve (St. Jude Medical pressure-wire)

CAD patients submitted to coronary angiography and in which coronary lesions are to be evaluated with pressure-wire (FFR functional evaluation)

Sponsors & Collaborators

  • Portuguese Association of Interventional Cardiology

    collaborator OTHER

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Portuguese Society of Cardiology

    lead OTHER

Principal Investigators

  • Sergio B Baptista, MD · Hospital Fernando Fonseca, Amadora, Portugal

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-11-30
Completion
2014-11-30

Countries

  • Portugal

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 NCT01835808 on ClinicalTrials.gov