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

Use our guide to learn which trials are right for you!

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.


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
3451 Walnut St
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...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Aalst, 9300
Principal Investigator: Stephan Fournier, MD
Phone: 32 53 72 41 68
?
mi
from
Aalst,
Click here to add this to my saved trials
New York, New York 10032
Principal Investigator: Ajay Kirtane
Phone: 212-342-3485
?
mi
from
New York, NY
Click here to add this to my saved trials
Roslyn, New York 11576
Principal Investigator: Allen Jeremias, MD
Phone: 516-562-6790
?
mi
from
Roslyn, NY
Click here to add this to my saved trials
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Phone: 650-498-6279
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
?
mi
from
Stanford, CA
Click here to add this to my saved trials