Overview

This trial is active, not recruiting.

Condition coronary artery disease
Sponsor Spectrum Health Hospitals
Start date November 2011
End date October 2021
Trial size 500 participants
Trial identifier NCT01694368, 2011-285

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
MACCE
time frame: 5 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Subject is at > 18 years of age 2. Subject presents to the catheterization laboratory to undergo clinically-indicated, invasive coronary angiography 3. Subject is willing and able to provide informed written consent 4. 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 5. Coronary anatomy is deemed suitable for combined NIRS-IVUS by the interventional cardiologist performing invasive angiography and intervention Exclusion Criteria: 1. Subject is pregnant or suspected to be pregnant 2. Subject is unable to provide informed consent 3. Subject has coronary artery anatomy deemed by interventionalist as unsuitable for NIRS-IVUS

Additional Information

Official title Multimodality Advanced Intracoronary Imaging With Near-infrared Spectroscopy and Intravascular Ultrasound to Characterize Coronary Artery Plaques Before and After Percutaneous Intervention
Principal investigator Ryan D Madder, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Spectrum Health Hospitals.