Fluoroscopy vs Cardiac Positioning System Comparison to Assist the Navigation and Positioning of a Balloon Catheter in a Peripheral Artery During an Angioplasty Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Time of radiation
研究概览
简要总结
This clinical investigation is intended to evaluate the ability of a magnetic cardiac positioning system to decrease medical radiation exposure on a peripheral angioplasty procedure in patients with a peripheral artery stenosis.
详细描述
The present study aims at addressing the fluoroscopy exposure time concern among physicians by proposing a new methodology that capitalizes on the cardiac positioning system (CPS) to reach near-zero fluoroscopy time for interventional cardiologists.
Intracoronary navigation of balloon catheter toward an anatomical landmark will be done with two navigation method:
- Fluoroscopy alone
- Fluoroscopy + CPS combination.
The order of the navigation method (method 1 then method 2 or vice versa) will be determine arbitrarily determined for each subject.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •At least 18 years of age;
- •Scheduled for clinically indicated or contemplated percutaneous transluminal angioplasty or stenting of an peripheral artery;
- •Able to provide informed consent for study participation and willing and able to comply with the Clinical Investigational Plan described evaluation.
排除标准
- •Pregnant women or women planning to be pregnant during the study.
- •Patients currently participating in another clinical study
- •Patients with a thrombophilia
- •Patients with critical limb ischemia
- •Patients with unstable clinical condition or conditions limiting life expectancy that, in the opinion of the Study Investigator, excludes the participation.
结局指标
主要结局
Time of radiation
时间窗: Changes from time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over 2 hours.
Medical radiation exposure for each balloon positioning
次要结局
- Dose area product (DAP)(DAP change from when balloon leaves the sheath to final alignment with anatomical landmark assessed every 15 minutes over a 2 hours time frame.)
- Number of adverse events.(At end of procedure)
- Volume of contrast required to get the balloon to the anatomical landmark.(Change of volume of contrast from when balloon leaves the sheath to final alignment with anatomical landmark assessed every 15 minutes over a 2 hours time frame.)
- Distance measurements(At end of procedure)
- Time duration(From time the balloon leaves the sheath to final alignment with anatomical landmark every 15 minutes over a 2 hours time frame.)
- Success or no-success in balloon navigation(Determined every 15 minutes over a 2 hours time frame.)