Description
Prospective, multi-center, observational, technical validation study of PCD-CT for plaque quantification, using IVUS as the reference plaque imaging technique, and 2 sub-studies to assess performance improvement and between-scan reproducibility. This is an observational study. There is no diagnostic or therapeutic intervention, and study participation will not affect standard patient management. The human subject study procedures are expected to be completed over the course of 1 year. The project is designed as a decentralized collaboration for practical reasons. At each site a study protocol that fits the local setting will be reviewed by the IRB at each site. The site protocols will be aligned for the primary endpoint but allow for flexibility regarding the secondary endpoints. After completion of the study, and with appropriate data transfer agreements in place, de-identified data will be shared with other study sites and the sponsor (Siemens). After image data analysis, anonymous data can be shared with investigators at the other sites for manuscript preparation. Information on data sharing is included in the patient information form.
