The Peripheral Vascular Core Laboratory (PVCL) provides independent, unbiased interpretation of the results of pharmaceutical or mechanical intervention in peripheral vascular disease as imaged through angiography, abdominal ultrasound, CT, MRI, and x-ray.
The PVCL has gained experience in the analysis of CT, MRI, angiographic, x-ray, and ultrasound data for multiple large multi-center trials, including 6 endovascular device trials. We have analyzed data for over 2,500 patients with typical study durations of 5 years.
Our core laboratory reduces inter-observer variability through the use of computer-assisted quantitative analysis techniques, a consistent set of analysis definitions, uniform technician training and variability testing. Each exam undergoes a multi-review process. Clinical Research Assistants perform qualitative and quantitative analyses of the images and record the results on worksheets specifically designed for each study and each imaging modality. A physician then corroborates these results.
Under the guidance of the Medical Director, the core lab will develop a customized set of analysis definitions for each type of exam to be analyzed. The definitions will be based on the pertinent data that is to be collected on clinical case report forms, and will include a more detailed analysis as recommended by the Medical Director, or as required by the sponsor. Core Lab personnel and collaborating physicians will be trained on the analysis definitions and will be familiarized with the specific design of the clinical trial and the treatment.
The Core Lab is experienced with advanced 3D imaging techniques for CT datasets. Using TeraRecon Aquarius workstations we can obtain many detailed analyses, including centerline vessel analysis, volume measurements, 3D/volume rendering and Curved Planar Reformatting, 4D analysis of cardiac gated studies, evaluation of stenosis, thrombosis, and calcification of vessels, and detailed device integrity assessments.
Paul Bishop, MSEE - Manager
bishopp @ ccf.org