Clinical trial NCT03226262: FFRangio Accuracy vs. Standard FFR
Official title: FFRangio Accuracy vs. Standard FFR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: CathWorks Ltd.
Sponsor class: INDUSTRY
Collaborators: name: CRF
First posted: 2017-07-21
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with stable angina, unstable angina or NSTEMI who are referred to coronary angiography and have an invasive FFR measurement with vasodilation in at least one coronary artery. Each subject will undergo both the standard invasive FFR and the investigational FFRangio.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and specificity of the dichotomously scored FFRangio measured index compared to invasive FFR
timeFrame: 1 hour
Secondary outcomes:
measure: Continuously scored FFR (FFRangio and Invasive FFR).
timeFrame: 1 hour
measure: Accuracy, Positive predictive value and negative predictive value per vessel and per lesion
timeFrame: 1 hour
measure: Sensitivity and specificity of the dichotomously scored FFRangio measured index per lesion as measured by the site.
timeFrame: 1 hour
measure: Device Success
timeFrame: 1 hour
measure: Usability of FFRangio
timeFrame: 1 hour
measure: Comprehensiveness of the FFRangio User Manual in providing adequate instructions
timeFrame: 1 hour
measure: Procedure related Adverse and Serious Adverse Events
timeFrame: 1 hour
measure: Device related Adverse and Serious Adverse Events
timeFrame: 1 hour
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: New York
country: United States
facility: Columbia University Medical Center/NewYork Presbyterian Hospital
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Aalst
country: Belgium
facility: OLV Ziekenhuis
city: Copenhagen
country: Denmark
facility: Rigs Hospital CPH
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Petah Tikva
country: Israel
facility: HaSharon Hospital
Study officials:
References:
citation: Fearon WF, Achenbach S, Engstrom T, Assali A, Shlofmitz R, Jeremias A, Fournier S, Kirtane AJ, Kornowski R, Greenberg G, Jubeh R, Kolansky DM, McAndrew T, Dressler O, Maehara A, Matsumura M, Leon MB, De Bruyne B; FAST-FFR Study Investigators. Accuracy of Fractional Flow Reserve Derived From Coronary Angiography. Circulation. 2019 Jan 22;139(4):477-484. doi: 10.1161/CIRCULATIONAHA.118.037350.