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

Coronary Artery Disease Clinical Trial

— SAVOIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901446
• Other study ID #: 0112
• Status: Completed
• Phase: N/A
• First received: May 11, 2009
• Last updated: September 13, 2010
• Start date: May 2009
• Est. completion date: May 2010

Study information

• Verified date: September 2010
• Source: InfraReDx
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and SportNetherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

• 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.

• Subject has history of intracranial bleeding or aneurysm.

• Subject has a history of stroke that precludes the use of routine antithrombotic agents during PCI?

• Subject has known hypercoagulable state, coagulopathy, or abnormal bleeding.

• subject has family history of coagulopathy or bleeding diathesis.

• subject has undergone PCI in the last 30days.

• subject enrolled or participating in pharmaceutical study in last 30 days.

• subject enrolled or participating in medical device treatment study in last 30 days.

• subject has obstructive LMCA disease.

• subject has multivessel CAD that requires additional treatment in a separate procedure with 30days of enrollment.

• subject has unprotected left main disease.

• three vessel intervention is required during enrollment procedure.

• target artery is the left circumflex artery.

• target artery is accessed through a vein or arterial graft.

• target artery is tortuous

• target artery contains segments of severe calcification

• target artery has >2 serial obstructions exceeding 50%DS.

• target artery has an aneurysm or suspected aneurysm.

• target artery has <=1 TIMI flow.

• target lesion is >99% DS.

• target lesion is severely calcified

• target lesion has angiographic characteristics of thrombus.

• target lesion has angiographic characteristics of ulceration.

• target lesion has inclusion of a side branch greater than 1mm.

• target lesion is located in a vessel segment with >4.0mm reference vessel diameter.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
InfraReDx

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obtain registered NIRS and IVUS data from a single catheter placement and single imaging run.		day 0	No
Secondary	The imaging tip can be positioned in the mid segment of the target artery.		day 0	No
Secondary	The lumen boundary of the target stenosis can be distinguished within the IVUS data set.		day 0	No
Secondary	The external elastic membrane (EEM) of the target stenosis can be distinguished within the IVUS data set.		day 0	No
Secondary	The lumen and EEM can be distinguished in the same cross section of the IVUS data set.		day 0	No

External Links

•   Sponsor Website