Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study

CAD - Coronary Artery Disease Clinical Trial

Official title:

Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005028
• Other study ID #: FFRAngio 1.0
• Status: Completed
• Phase: N/A
• First received: December 19, 2016
• Last updated: February 8, 2018
• Start date: January 2015
• Est. completion date: March 15, 2016

Study information

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

Clinical Trial Summary

In the present study we aim at validating the computation of FFRangio values from the angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a completely blinded manner. Investigation of a wide range of users in various conditions may strengthen the reliability of the FFRAngio measurements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: March 15, 2016
• Est. primary completion date: March 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female above 18 years old age which undergo FFR as part of their standard care

• TIMI Grade Flow is equal to 3

• LVEF larger than 45%.

• Subjects with multi-vessel coronary artery disease, with NSTEMI are allowed.

Exclusion Criteria:

• Contraindicated for FFR examination or adenosine administration

• STEMI

• CTO

• TIMI Grade Flow below 3

• Arteries supplying akinetic or severe hypokinetic territories

• Prior CABG on the study vessel

• Left Main stenosis, In-stent restenosis and Collaterals

• Diffused atherosclerosis diseases and tandem lesions

• Aorto-ostial lesion

Related Conditions & MeSH terms

• CAD - Coronary Artery Disease
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah Tiqva

Sponsors (1)

Lead Sponsor	Collaborator
CathWorks Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion-specific image-based FFRAngio calculation, compared to the invasive FFR as the reference gold standard, with a blinded analysis yielding Bland- Altman of +/- 15% with 95% CI	Immediately following the invasive FFR procedure.	1 hour