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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imaging | Subjects who receive intracoronary imaging with the investigative device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular ultrasound and spectroscopy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Obtain registered NIRS and IVUS data from a single catheter placement and single imaging run. | day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited from the patients presenting to the cardiac catheterization laboratory for elective cardiac catheterization.
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Serruys, MD | Erasmus Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Center | Rotterdam | Netherlands |
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| Label | URL |
|---|---|
| Sponsor Website | View source |
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|
| 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 |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| ID | Term |
|---|---|
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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