FFRangio Accuracy vs. Standard FFR

NCT03226262 | Completed FDA Device

• 1 other identifier: CWX-03
• Study Type: observational
• Target: 382
• Locations: 4 countries
• Sites: 9

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the dichotomously scored FFRangio measured index compared to invasive FFR

  Sensitivity and specificity of the dichotomously scored FFRangio measured index per vessel as compared with invasively-derived FFR; Index ≤ 0.80 is scored "positive" while Index \> 0.8 is negative.

  1 hour

Secondary Outcomes (8)

• Continuously scored FFR (FFRangio and Invasive FFR).

  1 hour

• Accuracy, Positive predictive value and negative predictive value per vessel and per lesion

  1 hour

• Sensitivity and specificity of the dichotomously scored FFRangio measured index per lesion as measured by the site.

  1 hour

• Device Success

  1 hour

• Usability of FFRangio

  1 hour

Interventions

FFRangio DEVICE

FFRangio is a non-invasive image-based software device that provides physicians with a quantitative analysis of functional significance of the coronary lesion, similar to invasive FFR (Fractional Flow Reserve), and a qualitative three-dimensional model of the demonstrated coronary arteries, during routine PCI procedure. The CathWorks FFRangio software device is able to perform all required processing and calculations, based only on angiography images and hemodynamics information that are acquired during the coronary catheterization procedure. The CathWorks FFRangioTM technology does not require any additional use of invasive devices, or any additional vasodilation treatment, as required by other known FFR techniques.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• CathWorks Ltd.: lead
• CRF: collaborator

Study Sites (9)

Stanford University

Stanford, California, 94305, United States

Location

Columbia University Medical Center/NewYork Presbyterian Hospital

New York, New York, 10032, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6061, United States

Location

OLV Ziekenhuis

Aalst, 9300, Belgium

Location

Rigs Hospital CPH

Copenhagen, 2100, Denmark

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

HaSharon Hospital

Petah Tikva, 49100, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Related Publications (1)

• 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.

  PMID: 30586699 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 21, 2017
• Study Start: September 27, 2017
• Primary Completion: June 8, 2018
• Study Completion: June 8, 2018
• Last Updated: June 25, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); IL (3); BE (1); DK (1)