RADIQAL Study (Radiation Dose and Image Quality Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 824
- 试验地点
- 14
- 主要终点
- Patient radiation dose and procedural performance (ClarityIQ vs Xres5)
研究概览
简要总结
The Azurion R4.0 is developed by Philips Medical Systems Nederland B.V., a Philips Healthcare company. The Azurion is an interventional X-ray system which is used for live X-ray imaging during invasive cardiac procedures. The proposed Azurion R4.0 includes new x-ray image postprocessing (Xres5) compared to its predecessor, which was equipped with ClarityIQ image post-processing (Xres4).
Azurion R4.0 is a cleared device for EU-MDR regulated countries, submission for FDA510K clearance in the US is pending. Sites in the US will only be activated in the study after FDA clearance.
This is a prospective, randomized, unblinded, comparative, international, multi-center clinical investigation. Randomization will be 1:1 between Xres5 and ClarityIQ (Xres4). Stratification will be performed per site on intended procedure type (based on clinical presentation) and patient BMI.
Primary objective is to demonstrate that in coronary procedures, Xres5 can reduce overall patient radiation dose compared to the current ClarityIQ without affecting procedural performance.
It is expected that 824 subjects are necessary to collect sufficient data for the evaluation of the objectives of this clinical study. The enrollment period is expected to last for 12 months. The study will be executed in Spain, Czech republic, Denmark and the US.
详细描述
The study procedures consist of three main steps: 1) patient screening and written informed consent, 2) baseline assessment and randomization and 3) treatment with the Azurion system with Xres5 [intervention] or the standard of care (ClarityIQ/Xres4) [control]. Patients will be randomly assigned to either the intervention group or the control group (using the standard of care) in a 1:1 ratio. The coronary procedure will be conducted as per institutional standards and at the discretion of the operator, but the standard image processing will be based on the randomization result. If randomized to the intervention group (Xres5), it will always be possible for the operator to cross over to the standard of care imaging processing (Clarity IQ). For the study sites in EU the primary staff in the intervention room will be wearing electronic staff dosimeters which will log the radiation exposure per staff member per procedure.
After the procedure, characteristics of the patient and procedure are captured in an eCRF. The imaging runs will be uploaded in the cloud after de-identification. After the study the radiation dose (DAP and Air Kerma) will be read out from the system.
The study procedures will end after the coronary procedure is completed. There will be no modifications in the standard of care patient treatment or follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Subject will be undergoing a diagnostic angiography and/or coronary intervention /elective PCI.
- •Subject is able to give written informed consent.
- •Subject is 18 years of age or older, or of legal age to give informed consent per state or national law.
排除标准
- •Subject with known contrast allergy that cannot be adequately premedicated.
- •Subject with previous contraindication for diagnostic angiography and/or diagnostic/elective PCI.
- •Subject participates in a potentially confounding drug or device study during the course of the study.
- •All vulnerable subjects such as pregnant or breast-feeding women, or any other subject who meets an exclusion criteria according to applicable national laws, if any.
- •Subject unwilling or unable to comply with the protocol and/or unable to understand verbal and/or written informed consent.
- •Expected use of non-standard contrast concentrations (e.g. dilution of contrast).
研究组 & 干预措施
Control (ClarityIQ)
the standard of care (ClarityIQ/Xres4)
干预措施: Azurion with Clairy IQ (Other)
Intervention (Xres5)
treatment with the Azurion system with Xres5
干预措施: treatment with the Azurion system with Xres5 (Device)
结局指标
主要结局
Patient radiation dose and procedural performance (ClarityIQ vs Xres5)
时间窗: during study procedure
\- Cumulative Dose Area Product (DAP) \[Gycm2\] Total patient group - All procedure types
次要结局
- Ultra-low dose cine fluoro rate (Xres5)(During study procedure)
- Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)(During study procedure)
- Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)(During study procedure)
- Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)(During study procedure)
- Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)(During study procedure)
- Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)(During study procedure)