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.
Study Type
OBSERVATIONAL
Enrollment
35
The medical research and development fund for health services Hillel Yaffe
Hadera, Israel
Rambam Health Corporation
Haifa, Israel
Professional user feedback regarding clinical utility of the SyncVision 4.X system
After the procedure the physician will be asked to rate and comment on the clinical utility and features of the SyncVision 4.X system in the post-study user evaluation questionnaire. This will include questions on the potential of the system to facilitate clinical decision-making, utility of co-registration workflow and functionality, quality of the co-registration and user interface functions.
Time frame: Day 1 (Post-Procedure)
Difference between assessments
Differences between the clinical assessment based on the existing time-based pullback graph and clinical assessment based on the automated co-registration of pullback graph with the angio image are performed by using a rating system 1 - 5 (1=Unacceptable, …., 5=Excellent). The co-registration and functionality points assessed are: * Workflow associated with achieving Physiology values co-registration * Physiology values co-registration results display clear and functionality convenient for use * Angiogram \& Roadmap selection * Auto roadmap generation * Pathway indication and correction * Co-Registration sequence: Roadmap-navigation and calibrated graph navigation * Length measurements
Time frame: Day 1 (Post-Procedure)
Distinguish tandem, diffuse and mixed disease
Ability to distinguish tandem, diffuse and mixed disease based on the physiological pullback profile display and the co-registered physiological pullback profile display are performed by the use of a rating system 1 - 5 (1=Unacceptable, …., 5=Excellent). The points assessed and compared are: * Distinguish tandem lesions * Distinguish diffuse diseased lesions * Distinguish mixed diseased lesions
Time frame: Day 1 (Post-Procedure)
Comparison of pre-intervention expected distal-most iFR with post-intervention actual distal-most iFR values
Comparison of the pre-intervention expected distal-most iFR with the post-intervention actual distal-most iFR values is based on the comparison of real time pre- and post-intervention displayed iFR values on the physiological pullback profile display and the co-registered physiological pullback profile display.The points assessed and compared are: * Pre-intervention distal most iFR * Post-intervention iFR
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 (Post-Procedure)