Study of Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Combination Coronary Catheter
NCT ID: NCT00901446
Last Updated: 2010-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10 participants
OBSERVATIONAL
2009-05-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Imaging
Subjects who receive intracoronary imaging with the investigative 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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Infraredx
INDUSTRY
Responsible Party
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InfraReDx Inc.
Principal Investigators
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Patrick Serruys, MD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Centre
Locations
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Erasmus Medical Center
Rotterdam, , Netherlands
Countries
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Related Links
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Sponsor Website
Other Identifiers
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0112
Identifier Type: -
Identifier Source: org_study_id