User Evaluation Study of SyncVision System With Software v4.X
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT02915991
- Lead Sponsor
- Volcano Corporation
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 35
- 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
- Patient is unable to give written informed consent prior to using his/her study data for evaluation and documentation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 measurementsDistinguish 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 lesionsComparison 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
Trial Locations
- Locations (2)
Rambam Health Corporation
🇮🇱Haifa, Israel
The medical research and development fund for health services Hillel Yaffe
🇮🇱Hadera, Israel