FFRangio Accuracy vs. Standard FFR

Completed

Conditions studied: Coronary Artery Disease

In brief

This is a prospective, observational, multi-center, single-arm, clinical trial designed to assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to Invasive FFR for diagnosing hemodynamically significant coronary stenosis.

Key facts

Study ID

NCT03226262

Run by

CathWorks Ltd.

People needed

382

Starts

2017-09-27

Expected to finish

2018-06-08

Last updated by the study team

2018-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female subjects, >18 years of age.
• Patients with stable angina or unstable angina or NSTEMI, and in whom invasive FFR is being assessed in a non-culprit stenosis in at least one coronary artery.
• Subject is undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus.
• Provides written, informed consent (where required)

You may not qualify if…

• Contraindication for FFR examination or administration of vasodilators.
• Subject is presenting with acute infarct (STEMI) OR has documented prior STEMI on same side (right/left).
• CTO in target vessel.
• Prior CABG, heart transplant or valve surgery, or prior TAVI/TAVR.
• Known LVEF ≤45%.
• Arteries supplying akinetic or severe hypokinetic territories if already known based on prior imaging.
• TIMI Grade 2 or lower at baseline.
• Target lesion involves Left Main (stenosis >50%).
• PCI with stent in target vessel in past 12 months, or target vessel involves in-stent restenosis.
• Severe, diffuse disease defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree.
• Target coronary vessel is supplied by major collaterals.

Where it is running

• Stanford University — Stanford, California, United States
• Columbia University Medical Center/NewYork Presbyterian Hospital — New York, New York, United States
• St. Francis Hospital — Roslyn, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• OLV Ziekenhuis — Aalst, Belgium
• Rigs Hospital CPH — Copenhagen, Denmark
• Shaare Zedek Medical Center — Jerusalem, Israel
• HaSharon Hospital — Petah Tikva, Israel
• Rabin Medical Center — Petah Tikva, Israel

Full record on ClinicalTrials.gov

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