FFRangio Accuracy vs. Standard FFR
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/27/2018 |
Start Date: | September 27, 2017 |
End Date: | June 8, 2018 |
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.
assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to
Invasive FFR for diagnosing hemodynamically significant coronary stenosis.
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
We found this trial at
5
sites
Roslyn, New York 11576
Principal Investigator: Allen Jeremias, MD
Phone: 516-562-6790
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New York, New York 10032
Principal Investigator: Ajay Kirtane
Phone: 212-342-3485
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3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000

Principal Investigator: Daniel Kolansky, MD
Phone: 215-614-0090
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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