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Coordinator Instructions
The Ultrasound Reading Center provides independent validation and analysis of vascular ultrasound examinations performed in clinical trials. The services provided by the center in a clinical study generally fall into the following four areas.
1. Develop the detailed protocols for duplex ultrasound and other vascular examinations that are required for performing reproducible baseline and follow-up examinations of study subjects.
2. Train staff at clinical trial sites to acquire the ultrasound examination data in accordance with the trial’s protocol.
3. Perform standardized measurements and interpretations of the ultrasound examinations performed at the clinical trial sites.
4. Provide a validated vascular ultrasound data set for analysis to support the aims of the trial.
To date, the center has participated in 10 studies of stent devices that are now used clinically in the carotid, iliac and renal arteries. In all of these studies, the Ultrasound Reading Center provided the services listed above to maximize the quality and validity of the ultrasound examinations after placement of a stent or surgical intervention. The center has worked with 145 clinical sites in the United States, providing protocol manuals and site training, validation of data from ultrasound exams, and statistical services for analysis of the results. For these trials the center has processed more than 12,000 ultrasound examinations.
Please contact the Ultrasound Reading Center if you are interested in discussing how we can support your trial.
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