Ignite Creation Date:
2024-05-06 @ 1:33 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01835808
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2013-04-16
Brief Title:
Portuguese Study on The Evaluation of FFR Guided Treatment of Coronary Disease
Sponsor:
Portuguese Society of Cardiology
Organization:
Portuguese Society of Cardiology
Study Overview
Official Title:
Observational Study of the Evaluation of FFR in the Treatment of Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POST-IT
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None