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

Spectrum Health Hospitals1 site in 1 country500 target enrollmentNovember 1, 2011

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Spectrum Health Hospitals
Enrollment: 500
Locations: 1
Primary Endpoint: MACCE
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2011

End Date

September 1, 2021

Last Updated

8 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Spectrum Health Hospitals

Responsible Party

Principal Investigator

Ryan Madder, MD

Physician

Spectrum Health Hospitals

Eligibility Criteria

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