Coronary Artery Disease
Conditions
Keywords
Coronary catheterization, Instantaneous wave free ratio (iFR), Fractional Flow Reserve (FFR), automated co-registration
Brief summary
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
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.
Interventions
None listed
Sponsors
Volcano Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Professional user feedback regarding clinical utility of the SyncVision 4.X system | Day 1 (Post-Procedure) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference between assessments | Day 1 (Post-Procedure) | 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 |
| Distinguish tandem, diffuse and mixed disease | Day 1 (Post-Procedure) | 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 |
| Comparison of pre-intervention expected distal-most iFR with post-intervention actual distal-most iFR values | Day 1 (Post-Procedure) | 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 |
Countries
Israel
Outcome results
None listed