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

September 13, 2010 updated by: Infraredx

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Rotterdam, Netherlands
        • Erasmus Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • InfraReDx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Obtain registered NIRS and IVUS data from a single catheter placement and single imaging run.
Time Frame: day 0
day 0

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infraredx

Investigators

  • Principal Investigator: Patrick Serruys, MD, Erasmus Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

May 11, 2009

First Submitted That Met QC Criteria

May 11, 2009

First Posted (ESTIMATE)

May 13, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 14, 2010

Last Update Submitted That Met QC Criteria

September 13, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Intravascular ultrasound and spectroscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe