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

NCT00901446 | Completed DMC

• 1 other identifier: 0112
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Obtain registered NIRS and IVUS data from a single catheter placement and single imaging run.

  day 0

Secondary Outcomes (4)

• 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

Study Arms (1)

Imaging

Subjects who receive intracoronary imaging with the investigative device.

Device: Intravascular ultrasound and spectroscopy

Interventions

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.

Also known as: InfraReDx

Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the patients presenting to the cardiac catheterization laboratory for elective cardiac catheterization.

You may qualify if:

• \>=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

You may not qualify if:

• 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.
• Subject has low hemoglobin levels.
• Subject has active liver disease or dysfunction.
• subject diagnosed with acute pulmonary edema or congestive heart failure.
• Subject diagnosed or suspected to have acute myo-, peri-, or endo- carditis, cardiac tamponade, or dissected aortic aneurysm.
• Subject has significant valvular heart disease, cardiomyopathy, or congenital heart disease.

Sponsors & Collaborators

• Infraredx: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, Netherlands

Location

Related Links

• Sponsor Website

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction

Interventions

Spectrum Analysis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Patrick Serruys, MD

  Erasmus Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 13, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

NL (1)