PCI Criteria and Definitions for Identifying Compassionate Use and Exceptional Risk Cases (pdf) Updated January 2011

The Mass-DAC Criteria for Identifying Compassionate Use and Exceptional Risk file provides the the risk factors and definitions for variables used to determine if an individual case should be designated as compassionate use. In addition, the Exceptional Risk designation has additional protocols that need to be followed to qualify a patient procedure as an Exceptional Risk case. We have also provided several cases studies that provide examples of Exceptional Use cases.

Protocol details: ExceptionalRiskv2public.pdf.

Case Studies: ExceptionalRiskCaseStudies200910.pdf.