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

Completed

• Conditions: Multi Vessel Coronary Artery Disease

• Registration Number: NCT03455244
• Lead Sponsor: CathWorks Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-14
• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-06
• Primary Completion: 2018-05-02
• Study Completion: 2018-05-02
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of the dichotomously scored FFRangio measured index compared to invasive FFR	1 hour	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.

Secondary Outcome Measures

Name	Time	Method
Accuracy, Positive predictive value and negative predictive value per vessel and per lesion	1 hour
Continuously scored FFR (FFRangio and Invasive FFR).	1 hour	Regression of FFRangio on continuous FFR, with slope, intercept and the correlation coefficient.

Trial Locations

Locations (1)

Gifu Heart Center; 🇯🇵 Gifu, Japan