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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03455244
Other study ID # CWX-04
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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