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slow recruitment and change in regulatory landscape
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | 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. |
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| 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) |
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
- Patient is unable to give written informed consent prior to using his/her study data for evaluation and documentation
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Patiets that undergo a cardiac catheterization and pressure-wire assessment in the coronary arteries as per standard hospital practice.
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| Name | Affiliation | Role |
|---|---|---|
| Aaron Frimerman, Professor | The medical research and development fund for health services Hillel Yafe | Principal Investigator |
| Ariel Roguin, Professor | Rambam Healthcare Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The medical research and development fund for health services Hillel Yaffe | Hadera | 38100 | Israel | |||
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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:
| 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:
| Day 1 (Post-Procedure) |
| Rambam Health Corporation |
| Haifa |
| 3109601 |
| Israel |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |