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

NCT ID: NCT01835808

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 918 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-11-30

Brief 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.

Detailed Description

Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease (POST-IT9 is a national multicentric, prospective, consecutive (non selected) anonymous observational study of all patients submitted to coronary angiography and in which functional evaluation with pressure-wire of coronary lesions is to be performed. The main purpose of the registry is to collect data on the medical decisions and clinical results in CAD patients evaluated with FFR (using pressure-wire®, St. Jude Medical), in order to provide evidence in "real world" non selected patients. This evidence will add to the already available clinical data from randomized trials. All Portuguese interventional cardiology centers performing regularly FFR studies were invited to participate in the study. Data will be collected at the time of the procedure and patients will be clinically followed-up for 1 year. Information concerning medical history, past exams, the angiography, the FFR study and the follow-up will be collected on registry forms. The treatment strategy for each patient will be decided by the operator physician, according to his best clinical judgment. Changes in treatment strategy due to FFR results will be recorded, but the intention of the study is just to collect clinical information, and not to influence physician practice. An informed consent form must be signed for all patients included. Patients will be free to withdraw this consent at anytime.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Fractional Flow Reserve

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

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

Intervention Type: DEVICE

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

Interventions

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)

Intervention Type: DEVICE

Other Intervention Names

Pressure-Wire (St. Jude Medical)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Patient not willing to participate (informed consent not signed).
• Life expectancy lower than 12 months (due to cardiac or non-cardiac disease)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Portuguese Association of Interventional Cardiology

OTHER

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Portuguese Society of Cardiology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sergio B Baptista, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Fernando Fonseca, Amadora, Portugal

Locations

CNCDC

Coimbra, Coimbra District, Portugal

Countries

Portugal

References

Baptista SB, Raposo L, Santos L, Ramos R, Cale R, Jorge E, Machado C, Costa M, Infante de Oliveira E, Costa J, Pipa J, Fonseca N, Guardado J, Silva B, Sousa MJ, Silva JC, Rodrigues A, Seca L, Fernandes R. Impact of Routine Fractional Flow Reserve Evaluation During Coronary Angiography on Management Strategy and Clinical Outcome: One-Year Results of the POST-IT. Circ Cardiovasc Interv. 2016 Jul;9(7):e003288. doi: 10.1161/CIRCINTERVENTIONS.115.003288.

Reference Type: DERIVED

PMID: 27412867 (View on PubMed)

Other Identifiers

POST-IT

Identifier Type: -

Identifier Source: org_study_id