Clinical Studies for
FFR and FFRangio
Read below to learn how routine use of FFRangio can reduce unnecessary stenting, improves outcomes, and reduces costs compared to angiography alone.
Read the Fast-FFR Pivotal TrialFFRangio Clinical Evidence
FFRangio is supported by strong clinical evidence proving excellent diagnostic performance vs. invasive wire based FFR.
FFRangio Validation Study
The FFRangio Validation study evaluated 203 lesions in 184 patients and showed that there is high concordance between FFRangio and invasive FFR, including a diagnostic accuracy of 93%.
Read MoreFAST-FFR Pivotal Trial
The FAST-FFR pivotal trial was a prospective multicenter, international trial designed to determine the accuracy of FFRangio in clinical practice compared to traditional wire-based FFR. The trial included 301 patients and 319 vessels at 10 clinical sites.
Read MoreFFRangio in Dual/Triple Vessel Disease
This prospective clinical study conducted at Gifu Heart Centre, Japan—evaluated the diagnostic performance of FFRangio in 50 patients with dual or triple vessel CAD compared to wire-based FFR.
Read MoreFFRangio Pooled Analysis from 5 Prospective Cohort Studies
This lesion-level pooled data analysis of 588 patients and 700 lesions represents the “largest and most diverse cohort of any single angiogram-based FFR technology reported.”
Read MoreClinical Evidence on FFR for PCI Decision-Making
Angiography alone is a poor predictor of physiological significance. Studies show routine use of FFR is proven to improve patient outcomes, cut costs, and reduce unnecessary stenting.
FAME Trial
The FAME trial compared FFR-guided PCI decision- making (by pressure wire) versus PCI guided by angiography alone in 1,005 randomized patients with multi-vessel coronary artery disease. Routine measurement of FFR significantly reduced clinical events at 1 year.
Read MoreFAME Trial Economic Analysis
Economic analysis of the FAME Trial revealed that PCI guided by FFR saves costs and improves health outcomes at 1 year compared with angiography guidance. Cost savings are driven by a decrease in stent use during the initial procedure, a decrease in rehospitalization and fewer major adverse cardiac events.
Read MoreFAME II Trial
The FAME II Trial randomized stable CAD patients with FFR ≤ 0.80 to PCI + medical therapy or medical therapy alone. Enrollment was halted early after 1,220 patients
Read MoreFFR in Clinical Guidelines
Consistent use of FFR is supported by worldwide clinical guidelines.
2011
2016
ACC/AATS/AHA/ASE/ASNC/ SCAI/SCCT/STS
Appropriate Use Criteria for Coronary Revascularization in Patients with Acute Coronary Syndromes
Read More2017
ACC/AATS/AHA/ASE/ASNC/ SCAI/SCCT/STS
Appropriate Use Criteria for Coronary Revascularization in Patients with Stable Ischemic Heart Disease
Read More2018
Physician Perspectives on FFRangio
CVIT 2021: Dr. Rahul P. Sharma, Stanford Medical Center, shares his experience with the latest FFRangio software, and discusses important benefits of FFRangio for routine clinical practice.
Watch the CVIT presentation
