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OpenTrials
Completed

NCT Number: NCT01694368

Intracoronary Imaging With NIRS-IVUS to Characterize Arterial Plaques

To characterize atherosclerotic coronary artery plaques using advanced intra-coronary imaging with a combined near-infrared spectroscopy and intravascular ultrasound catheter before and after percutaneous intervention

Completed

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Spectrum Health; Frederik Meijer Heart &Vascular Institute

Grand Rapids, Michigan, 49503, United States

About this study

This study is being performed to characterize the composition and morphologic characteristics of atherosclerotic coronary artery plaques with intra-coronary near-infrared spectroscopy and intravascular ultrasound in patients undergoing percutaneous coronary intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is at > 18 years of age
  • Subject presents to the catheterization laboratory to undergo clinically-indicated, invasive coronary angiography
  • Subject is willing and able to provide informed written consent
  • Subject is found to have ≥ 1 severe coronary artery stenosis by invasive angiography and percutaneous coronary intervention is planned for definitive treatment or found to have ≥ 1 intermediate coronary artery stenosis and IVUS planned for lesion assessment
  • Coronary anatomy is deemed suitable for combined NIRS-IVUS by the interventional cardiologist performing invasive angiography and intervention

Exclusion criteria

  • Subject is pregnant or suspected to be pregnant
  • Subject is unable to provide informed consent
  • Subject has coronary artery anatomy deemed by interventionalist as unsuitable for NIRS-IVUS

Treatment and study plan

Primary outcomes

  1. MACCE

    Time frame: 5 year

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Registry information

Official study title

Multimodality Advanced Intracoronary Imaging With Near-infrared Spectroscopy and Intravascular Ultrasound to Characterize Coronary Artery Plaques Before and After Percutaneous Intervention

Acronym: NIRS-IVUS

Important dates

Study start
2011
Primary completion
2016
Study completion
2021
First posted
Sep 27, 2012
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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