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NCT01694368 Clinical Trial

Intracoronary Imaging With NIRS-IVUS to Characterize Arterial Plaques

Coronary Artery Disease Clinical Trial

— NIRS-IVUS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01694368
Other study ID # 2011-285
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2011
Est. completion date September 2021

Study information
Verified date May 2024
Source Spectrum Health Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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 information / eligibility
Status Completed
Enrollment 500
Est. completion date September 2021
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Spectrum Health; Frederik Meijer Heart &Vascular Institute Grand Rapids Michigan

Sponsors (1)
Lead Sponsor Collaborator
Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary MACCE 5 year
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