User Evaluation Study of SyncVision System With Software v4.X

Prospective, Single Arm, Open Label, User Evaluation Sudy of SyncVision System With Software v4.X

This is a prospective, single-arm, unblinded, case observation study evaluating a commercially released 'Conformité Européenne' (CE)-mark co-registration software system along-side of a commercially- released CE-mark coronary physiology and X-ray system during routine clinical workflow. The purpose of this study is to collect Professional user feedback regarding clinical utility of the SyncVision 4.X system.

The PREPARE II study will enroll a maximum of 200 patients in up to 5 sites. No follow-up will be performed. The PREPARE II study will only collect data during diagnostic angiogram or percutaneous coronary intervention (PCI) procedure, when performed as per standard hospital care.

Inclusion Criteria:

• Patients eligible and indicated for cardiac catheterization and pressure-wire assessment in the coronary arteries as per standard hospital practice
• Males over the age of 18 years and post-menopausal females
• Patient is able to give written informed consent prior to using his/her study data for evaluation and documentation

Exclusion Criteria:

- Patient is unable to give written informed consent prior to using his/her study data for evaluation and documentation