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NIRS-IVUS to Improve Assessment of Coronary Artery Disease Severity in Patients Referred for Transcatheter Aortic Valve Implantation

NCT04976062 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2022-11-04

No results posted yet for this study

Summary

The aim of the IMPACTavi prospective cohort study is to test feasibility and safety of clinically indicated intravascular coronary imaging with NIRS-IVUS in addition to routine coronary angiography in patients scheduled for TAVI, to improve assessment of CAD severity in this challenging group of patients.

Conditions

Interventions

DIAGNOSTIC_TEST

Combined near-infrared spectroscopy and intravascular ultrasound imaging (NIRS-IVUS)

The NIRS-IVUS technique is an intravascular imaging technique, combining morphological information derived from intravascular ultrasound (IVUS) and molecular information on plaque composition, namely its respective lipid-core burden, using spectral differences between cholesterol and collagen, detected by near-infrared spectroscopy (NIRS). A combined NIRS-IVUS pullback results in a color-coded map indicating the probability of lipid-rich plaque presence in yellow, co-registered to the corresponding IVUS cross-sections.

Sponsors & Collaborators

  • Infraredx Inc

    collaborator UNKNOWN

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Michael Joner, MD · Deutsches Herzzentrum München

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-10
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Germany
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT04976062 on ClinicalTrials.gov