Simultaneous Acquisition of Intravascular Ultrasound and Near Infrared Spectroscopy Data in the Coronary Artery Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atherosclerosis
- Sponsor
- Infraredx
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Obtain registered NIRS and IVUS data from a single catheter placement and single imaging run.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\>=18yrs of age.
- •diagnosed with stable angina pectoris or documented silent ischemia
- •scheduled for elective, non-emergent cardiac catheterization
- •able to read, understand, and provide written informed consent
- •\>=1 obstructive stenosis (\>50%DS by visual estimate)in a major native coronary artery
- •clinically indicated treatment plan includes placement of a guidewire into the target artery.
- •target artery has a \>=30mm segment with a reference vessel diameter \>=2.5mm
- •target artery has a \>50%DS luminal narrowing
Exclusion Criteria
- •Subject unwilling or unable to provide written informed consent.
- •Subject unwilling to comply with protocol
- •Subject is pregnant
- •Subject is of childbearing potential without negative pregnancy test.
- •Subject received prolonged CPR within 2 weeks of enrollment procedure
- •Subject is intubated.
- •Subject is diagnosed with an acute coronary syndrome.
- •Subject has severe persistent hypertension.
- •Subject has renal dysfunction or insufficiency.
- •Subject has an abnormal platelet count.
Outcomes
Primary Outcomes
Obtain registered NIRS and IVUS data from a single catheter placement and single imaging run.
Time Frame: day 0
Secondary Outcomes
- The imaging tip can be positioned in the mid segment of the target artery.(day 0)
- The lumen boundary of the target stenosis can be distinguished within the IVUS data set.(day 0)
- The external elastic membrane (EEM) of the target stenosis can be distinguished within the IVUS data set.(day 0)
- The lumen and EEM can be distinguished in the same cross section of the IVUS data set.(day 0)