MedTrace Logo

INTegrated Assessment of intERmediate Coronary Stenoses by Fractional Flow rEserve (FFR) and Near-infraREd Spectroscopy (NIRS)

NCT02985112 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2016-12-12

No results posted yet for this study

Summary

Revascularization of borderline coronary stenoses (40-70%) is usually driven by fractional flow reserve (FFR) which expresses the physiological significance of a lesion and tells the operator whether PCI may reduce the rate of adverse events as compared to medical therapy. Coronary stenoses with FFR value \< 0.80 are indeed associated with a higher rate of adverse event and requires coronary revascularization whereas lesions with FFR \> 0.80 show an excellent prognosis which cannot be improved by coronary stenting. Such a predictive value of FFR is theoretically based only on the degree of myocardial ischemia downstream from a given coronary stenosis: however, also plaque composition may play a crucial role in triggering future events especially in patients affected by acute coronary syndrome. Differences in plaque composition between FFR-positive and FFR negative lesions have never been assessed. Intracoronary Near-InfraRed Spectroscopy (NIRS) identifies lipid rich plaques that can potentially cause acute events. The aim of this study is to compare the lipid content expressed by LCBI (Lipid Core Burden Index) between functionally significant (FFR \< 0.80) and non-significant (FFR \> 0.80) stenoses in patients undergoing coronary angiography because of stable CAD and non-ST elevation acute coronary syndromes. This is an observational, prospective, multicentric study where we plan to collect 150 coronary lesions.

Conditions

  • Borderline Coronary Stenoses Assessment, Fractional Flow Reserve, Plaque Composition

Interventions

DEVICE

FFR and IVUS-NIRS

Sponsors & Collaborators

  • San Giovanni Addolorata Hospital

    collaborator OTHER

  • S.M. Misericordia Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02985112 on ClinicalTrials.gov