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

This study has been completed.
Sponsor:
Information provided by:
InfraReDx
ClinicalTrials.gov Identifier:
NCT00901446
First received: May 11, 2009
Last updated: September 13, 2010
Last verified: September 2010
  Purpose

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 Intervention
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Myocardial Infarction
Device: Intravascular ultrasound and spectroscopy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by InfraReDx:

Primary Outcome Measures:
  • Obtain registered NIRS and IVUS data from a single catheter placement and single imaging run. [ Time Frame: day 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The imaging tip can be positioned in the mid segment of the target artery. [ Time Frame: day 0 ] [ Designated as safety issue: No ]
  • The lumen boundary of the target stenosis can be distinguished within the IVUS data set. [ Time Frame: day 0 ] [ Designated as safety issue: No ]
  • The external elastic membrane (EEM) of the target stenosis can be distinguished within the IVUS data set. [ Time Frame: day 0 ] [ Designated as safety issue: No ]
  • The lumen and EEM can be distinguished in the same cross section of the IVUS data set. [ Time Frame: day 0 ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: May 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Imaging
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901446

Locations
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Sponsors and Collaborators
InfraReDx
Investigators
Principal Investigator: Patrick Serruys, MD Erasmus Medical Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Vice President of Clinical & Regulatory Affairs, InfraReDx Inc.
ClinicalTrials.gov Identifier: NCT00901446     History of Changes
Other Study ID Numbers: 0112
Study First Received: May 11, 2009
Last Updated: September 13, 2010
Health Authority: Netherlands: Ministry of Health, Welfare and Sport
Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on August 27, 2014