Prospective, Single Arm, Open Label, User Evaluation Sudy of SyncVision System With Software v4.X
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Professional user feedback regarding clinical utility of the SyncVision 4.X system
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient is unable to give written informed consent prior to using his/her study data for evaluation and documentation
结局指标
主要结局
Professional user feedback regarding clinical utility of the SyncVision 4.X system
时间窗: 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.
次要结局
- Difference between assessments(Day 1 (Post-Procedure))
- Distinguish tandem, diffuse and mixed disease(Day 1 (Post-Procedure))
- Comparison of pre-intervention expected distal-most iFR with post-intervention actual distal-most iFR values(Day 1 (Post-Procedure))