Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularisation (DEFINE-FLAIR)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Prospective, Multi-center, Double Blind, Randomised Study to Test the Safety of Deferral of Stenting in Physiological Non-significant Lesions in a Clinical Population of Intermediate Stenoses Using iFR and FFR|
- Major Adverse Cardiac Events [ Time Frame: 30 days, 1, 2 and 5 years ]Composite of death, myocardial infarction, unplanned revascularisation
- Death (all cause) [ Time Frame: 30 days, 1, 2 and 5 years ]
- Death (cardiovascular) [ Time Frame: 30 days, 1, 2 and 5 years ]
- Myocardial Infarction [ Time Frame: 30 days, 1, 2 and 5 years ]
- Repeat revascularisation [ Time Frame: 30 days, 1, 2 and 5 years ]
- Cost associated to iFR or FFR measurement [ Time Frame: 30 days, 1, 2 and 5 years ]Cost associated to iFR or FFR
- Quality of life [ Time Frame: 30 days, 1, 2 and 5 years ]
- Cost savings of removing secondary investigations [ Time Frame: 30 days, 1, 2 and 5 years ]7) Cost savings of removing secondary investigations, by assessing/treating non-culprit acute coronary syndrome (ACS) at the time of index presentation.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||December 16, 2020|
|Primary Completion Date:||January 19, 2017 (Final data collection date for primary outcome measure)|
Treatment guided by iFR
Treatment guided by instantaneous wave-free ratio
Active Comparator: FFR
Treatment guided by FFR
Treatment guided by Fractional Flow Reserve
Patients with one or more coronary stenoses, in which the physiological severity from coronary angiography is in question, will be randomised 1:1 to use of the instantaneous wave free ratio (iFR) or fractional flow reserve (FFR) to guide the treatment strategy for percutaneous coronary intervention (PCI).
To assess whether the iFR is non-inferior to FFR when used to guide treatment of coronary stenosis with PCI.
The primary endpoint will be major adverse cardiac event rate in the iFR and FFR groups at 30 days, 1, 2, and 5 years.
This will be an international multi-centre study of 2500 patients. From population estimates, 35% of the total study population will present with stable angina and 65% will have acute coronary syndrome.
Patients will be eligible when the physiological severity of a stenosis within a vessel is in question. In the cases of stable angina this will be confined to the target vessel, or with acute coronary syndrome assessment this will be made in the non-culprit vessel.
Anticipated recruitment is 12 months. Follow-up will be performed at 30 days, 1, 2 and 5 years.
Primary outcome results will be reported in Spring 2017.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02053038
Show 50 Study Locations
|Principal Investigator:||Justin ER Davies, MD||Imperial College London|
|Principal Investigator:||Javier Escaned, MD||Clinico San Carlos|
|Study Chair:||Patrick Serruys, MD||Imperial College London|
|Study Chair:||Manesh Patel, MD||Duke University|
|Study Director:||Sayan Sen, MD||Imperial College London|