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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00901446
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : September 14, 2010
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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.

Condition or disease Intervention/treatment
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Myocardial Infarction Device: Intravascular ultrasound and spectroscopy

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Simultaneous Acquisition of Intravascular Ultrasound and Near Infrared Spectroscopy Data in the Coronary Artery Study
Study Start Date : May 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Subjects who receive intracoronary imaging with the investigative device.
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.
Other Name: InfraReDx

Primary Outcome Measures :
  1. Obtain registered NIRS and IVUS data from a single catheter placement and single imaging run. [ Time Frame: day 0 ]

Secondary Outcome Measures :
  1. The imaging tip can be positioned in the mid segment of the target artery. [ Time Frame: day 0 ]
  2. The lumen boundary of the target stenosis can be distinguished within the IVUS data set. [ Time Frame: day 0 ]
  3. The external elastic membrane (EEM) of the target stenosis can be distinguished within the IVUS data set. [ Time Frame: day 0 ]
  4. The lumen and EEM can be distinguished in the same cross section of the IVUS data set. [ Time Frame: day 0 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from the patients presenting to the cardiac catheterization laboratory for elective cardiac catheterization.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00901446

Erasmus Medical Center
Rotterdam, Netherlands
Sponsors and Collaborators
Principal Investigator: Patrick Serruys, MD Erasmus Medical Centre

Additional Information:
Responsible Party: Vice President of Clinical & Regulatory Affairs, InfraReDx Inc. Identifier: NCT00901446     History of Changes
Other Study ID Numbers: 0112
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases