NCT00901446

Study of Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Combination Coronary Catheter

Simultaneous Acquisition of Intravascular Ultrasound and Near Infrared Spectroscopy Data in the Coronary Artery Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Infraredx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the technical performance and clinical handling of a coronary catheter that includes two imaging techniques. The catheter being evaluated performs near infrared spectroscopy and ultrasound imaging of the coronary arteries. Near infrared spectroscopy is used to identify lipid or cholesterol deposits in the vessel wall and the ultrasound component provides structural information about the vessel. Combining multiple imaging techniques into a single catheter can reduce the total number of catheters required during treatment and the overall duration of cardiac catheterization. Both of these results may lead to safer procedures.

Conditions

• Atherosclerosis
• Coronary Artery Disease
• Myocardial Ischemia
• Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Intravascular ultrasound and spectroscopy	Intracoronary imaging with a catheter based ultrasound transducer and near infrared spectroscopy tip that is pulled back at an automated rate of 0.5 millimeters per second.

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-05-13
• Last updated: 2010-09-14

Locations

1 site across 1 country: Netherlands