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.

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FFRangio 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%.

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FAST-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.

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FFRangio 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.

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FFRangio 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.”

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Clinical 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.

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FAME 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.

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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

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FFR in Clinical Guidelines

Consistent use of FFR is supported by worldwide clinical guidelines.



Guideline for Percutaneous Coronary Intervention

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Appropriate Use Criteria for Coronary Revascularization in Patients with Acute Coronary Syndromes

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Appropriate Use Criteria for Coronary Revascularization in Patients with Stable Ischemic Heart Disease

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Guidelines on Myocardial Revascularization

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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.

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Learn how the CathWorks FFRangio® System can impact your practice.


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