Status:
COMPLETED
Study of Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Combination Coronary Catheter
Lead Sponsor:
Infraredx
Conditions:
Atherosclerosis
Coronary Artery Disease
Eligibility:
All Genders
18+ years
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 spec...
Eligibility Criteria
Inclusion
- \>=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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00901446
Start Date
May 1 2009
End Date
May 1 2010
Last Update
September 14 2010
Active Locations (1)
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1
Erasmus Medical Center
Rotterdam, Netherlands