Status:
COMPLETED
Intravascular Near Infrared Spectroscopy (NIRS) Bifurcation - Lipid Core Plaque Shift Study
Lead Sponsor:
Infraredx
Collaborating Sponsors:
Columbia University
Conditions:
Angina Pectoris
Angina, Unstable
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
This pilot study is going to examine the hypothesis that in coronary arteries, soft lesions that contain lipid cores, but are not calcified or fibrotic and are located in proximity to side branches, a...
Detailed Description
Coronary artery bifurcations (branching areas) are predisposed to atherosclerosis from turbulent flow and increased shear stress. Dilating lesions that involve a branch vessel is associated with the r...
Eligibility Criteria
Inclusion
- Subject must be \>=40yrs
- Subject must provide written informed consent.
- Subject must be diagnosed with stable or unstable angina pectoris, or documented silent ischemia
- Subject must be scheduled for elective or non-emergent percutaneous coronary intervention
- Angiographic evidence of a bifurcation lesion with the following characteristics:
- Native coronary artery
- De novo coronary stenosis at the bifurcation site
- Bifurcation Medina class 1,1,0 or 1,0,0 or 0,1,0
- Main vessel stenosis \>50%, with the stenotic lesion in close proximity (≤2mm) to the side branch ostium, by visual estimate.
- Side branch diameter ≥ 2.0mm by visual estimate.
- Side branch without significant stenosis (\<30% stenosis)
- LipiScan catheter optical tip must cross lesion without the need for pre-dilatation
Exclusion
- Subject is pregnant or nursing
- Renal insufficiency (Creatinine \>2.0mg/dL)
- Left ventricular ejection fraction \<25% by visual estimate.
- Known allergy to contrast media that cannot be medically managed.
- Acute ST segment elevation myocardial infarction (STEMI) that has not been stabilized.
- Any condition or symptom that in the investigator's opinion may adversely alter the risk profile of this study for the subject.
- Target lesion is dilated prior to first LipiScan imaging.
- Subject experiences procedural complication that precludes clear post angioplasty imaging of the target lesion.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00905671
Start Date
June 1 2009
End Date
August 1 2011
Last Update
September 4 2014
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032