Intracoronary Imaging With NIRS-IVUS to Characterize Arterial Plaques
Completed
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01694368
- Lead Sponsor
- Spectrum Health Hospitals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MACCE 5 year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Spectrum Health; Frederik Meijer Heart &Vascular Institute
🇺🇸Grand Rapids, Michigan, United States