User Evaluation Study of SyncVision System With Software v4.X

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br>This is a single-arm study, so all patients enrolled will be in this arm and will undergo diagnostic catheterization procedure as per standard hospital care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 (Post-Procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Day 1 (Post-Procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary catheterization, Instantaneous wave free ratio (iFR), Fractional Flow Reserve (FFR), automated co-registration