The NAVIGATE-PCI Registry: A New Approach to VIew CT-derived Guidance Ahead of Stenting To Plan Efficient PCI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Primary Endpoint
研究概览
简要总结
The objective of Heartflow's NAVIGATE-PCI Registry is to collect observational data about the management of patients before and after deployment of Heartflow's PCI Navigator.
详细描述
Heartflow's NAVIGATE-PCI Registry is a post-market, multi-center, data collection registry assessing confidence in procedure planning, time of procedure, contrast usage during procedure, radiation usage during procedure, invasive imaging (angiographic or other), and resource utilization. Sites will provide retrospective data from patients receiving an elective PCI prior to the deployment of PCI Navigator vs. after deployment and operator training on how to use the information provided by PCI Navigator. Baseline demographic, medical history, procedural, and in-hospital outcome information will be collected following the procedure. No post discharge follow-up data will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •(all must be present):
- •CCTA completed ≤90 days prior to elective PCI with acceptable image quality according to Heartflow's image quality requirements
- •Referred for elective PCI
- •Clinically stable without symptoms suggestive of acute coronary syndrome (ACS) at the time of the intervention
排除标准
- •(all must be present):
- •ED presentation (at the time of the referral for PCI)
- •Previous coronary artery bypass graft (CABG)
- •Planned intervention in a previously stented vessel territory
- •Acute chest pain (in patients who have not been ruled out for ACS)
- •Participating in a conflicting study being undertaken during the PCI
研究组 & 干预措施
Group 1: No PCI Navigator
This group includes consecutive patients who have undergone a CCTA a maximum of 90 days prior to an elective PCI at the study site; the CCTA is not required to have been used in procedural planning but must have acceptable image quality according to Heartflow's image quality requirements
Group 2: Intraprocedural PCI Planning
This group includes patients who had a CCTA and a referral for elective PCI following the introduction of the PCI Navigator at the study site. The PCI should be performed no more than 90 days following the CCTA. Interventionalists will document their procedural plan after initial invasive angiographic images are reviewed but before reviewing the information provided by the PCI Navigator, and then again after reviewing the information provided by the PCI Navigator. Usage of invasive imaging following review of the PCI Navigator is at the discretion of the interventionalist.
干预措施: Heartflow PCI Navigator (Diagnostic Test)
Group 3: Preprocedural Planning
This group includes patients who had a CCTA and a referral for elective PCI following the introduction of the PCI Navigator at the study site. The PCI should be performed no more than 90 days following the CCTA. Interventionalists will document their procedural plan before reviewing the information provided by the PCI Navigator and prior to initial invasive angiographic imaging, and then again after reviewing the information provided by the PCI Navigator. Usage of angiographic and other invasive imaging following review of the PCI Navigator is at the discretion of the interventionalist.
干预措施: Heartflow PCI Navigator (Diagnostic Test)
结局指标
主要结局
Primary Endpoint
时间窗: 90 Days
The primary endpoint will be assessed only in Group 2 and is a change in procedural plan following review of the information provided by PCI Navigator compared to procedural plan with angiographic imaging alone. The primary endpoint will be measured by calculating the percentage of patients in whom a change of plan was documented following review of the PCI Navigator tool compared to the plan documented prior to using the tool.
次要结局
- Changes in confidence with and without PCI Navigator (assessed in Groups 2 and 3 as two separate analyses)(90 days for Group 2, 18 months for Group 3)
- Change in procedural time with and without PCI Navigator(90 days)
- Change in contrast usage with and without PCI Navigator(90 days)
- Change in radiation usage during PCI with and without PCI Navigator(90 days)
- Change in invasive imaging (angiographic or other) with and without PCI Navigator(90 days)
- Change in resource utilization with and without PCI Navigator(90 days)