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

NCT ID: NCT03455244

Last Updated: 2018-06-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-14
• Study Completion Date: 2018-05-02

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.

Conditions

Multi Vessel Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CathWorks Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gifu Heart Center

Gifu, , Japan

Countries

Japan

Other Identifiers

CWX-04

Identifier Type: -

Identifier Source: org_study_id