Intracoronary Imaging With NIRS-IVUS to Characterize Arterial Plaques
NIRS-IVUS
Multimodality Advanced Intracoronary Imaging With Near-infrared Spectroscopy and Intravascular Ultrasound to Characterize Coronary Artery Plaques Before and After Percutaneous Intervention
1 other identifier
observational
500
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 24, 2012
CompletedFirst Posted
Study publicly available on registry
September 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedAugust 7, 2025
August 1, 2025
4.8 years
September 24, 2012
August 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
MACCE
5 year
Eligibility Criteria
Coronary Artery Disease Patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spectrum Health; Frederik Meijer Heart &Vascular Institute
Grand Rapids, Michigan, 49503, United States
Related Publications (1)
Madder RD, Khan M, Husaini M, Chi M, Dionne S, VanOosterhout S, Borgman A, Collins JS, Jacoby M. Combined Near-Infrared Spectroscopy and Intravascular Ultrasound Imaging of Pre-Existing Coronary Artery Stents: Can Near-Infrared Spectroscopy Reliably Detect Neoatherosclerosis? Circ Cardiovasc Imaging. 2016 Jan;9(1):e003576. doi: 10.1161/CIRCIMAGING.115.003576.
PMID: 26729855DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan D Madder, MD
Corewell Health West
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
September 24, 2012
First Posted
September 27, 2012
Study Start
November 1, 2011
Primary Completion
September 1, 2016
Study Completion
September 1, 2021
Last Updated
August 7, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share