Intracoronary Imaging With NIRS-IVUS to Characterize Arterial Plaques

Spectrum Health Hospitals

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01694368

2011-285

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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