Intravascular Near Infrared Spectroscopy (NIRS) Bifurcation - Lipid Core Plaque Shift Study
Completed · Phase 4
Conditions studied: Angina Pectoris, Angina, Unstable, Atherosclerosis, Coronary Artery Disease
In brief
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, are associated with side branch compromise as a result of plaque shift during angioplasty and stenting. Plaque characteristics will be detected by intravascular near infrared spectroscopy (NIRS).
Key facts
- Study ID
- NCT00905671
- Run by
- Infraredx
- People needed
- 20
- Starts
- 2009-06-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2014-09-04
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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