Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease

Multi Vessel Coronary Artery Disease Clinical Trial

Official title:

Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03455244
• Other study ID #: CWX-04
• Status: Completed
• Start date: November 14, 2017
• Est. completion date: May 2, 2018

Study information

• Verified date: June 2018
• Source: CathWorks Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, observational, single-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 in Multi-Vessel Disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years of age.

• Patients with stable angina or unstable angina or NSTEMI, with at least 1 stenoses = 50% in two main vessels (LAD, LCX and/or RCA) each and in whom invasive FFR is being assessed at these stenoses.

• Patients undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus.

• Written, informed consent.

Exclusion Criteria:

• Contraindication for FFR examination or administration of vasodilators.

• Clinical presentation of an acute infarct (STEMI) or presented with STEMI in past year.

• CTO in a target vessel.

• Prior CABG, valvular surgery, TAVI/TAVR, or heart transplantation.

• 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 lesions involve Left Main (stenosis =50%.)

• In-stent restenosis in a target vessel.

• Heavily diffused atherosclerosis diseases defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree.

• Target coronary vessels are supplied by major collaterals.

• Lesion is in ectatic segment which includes dilatation in diameter at least 1.5 times that of the adjacent normal coronary artery.

• Coronary angiograms not acquired per instructions as defined in the Study Protocol.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Multi Vessel Coronary Artery Disease
• Myocardial Ischemia

Intervention

Device:
• FFRangio
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.

Locations

Country	Name	City	State
Japan	Gifu Heart Center	Gifu

Sponsors (1)

Lead Sponsor	Collaborator
CathWorks Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Continuously scored FFR (FFRangio and Invasive FFR).	Regression of FFRangio on continuous FFR, with slope, intercept and the correlation coefficient.	1 hour
Secondary	Accuracy, Positive predictive value and negative predictive value per vessel and per lesion		1 hour