NCT02927990终止不适用
Contrast Volume Reduction During Percutaneous Coronary Interventions With the Use of a New Assisting Software Package
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Amount [mL] of Contrast Used for Completion of the Coronary Intervention
研究概览
简要总结
The new software package is intended to assist the physician in imaging the coronaries during percutaneous coronary interventions.
This study investigates the amount of contrast used during percutaneous coronary interventions with the aid of the new software package.
The results of the study will be compared with control group data (before the new software package was installed or after it was removed) to define a possible contrast reduction.
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
- •Subject undergoing a percutaneous coronary intervention.
- •Subject 18 years of age or older, or of legal age to give informed consent per state or national law.
排除标准
- •Subject undergoing an emergency treatment
- •Primary angioplasty for acute ST segment elevation myocardial infarction.
- •Subject with contrast allergies
- •Subject with severe kidney disease (e-GFR < 40 by Modification of Diet in Renal Disease (MDRD)/Cockcroft Gault clearance formula and/or upon decision by investigator)
- •Subject participates in a potentially confounding drug or device trial during the course of the study.
- •Prisoners, people who cannot legally give consent, pregnant women and breastfeeding women.
结局指标
主要结局
Amount [mL] of Contrast Used for Completion of the Coronary Intervention
时间窗: Amount of contrast [mL] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
Phase 2 not initiated Only phase 1 data was collected
次要结局
- Cumulative Dose Area Product (DAP) of Percutaneous Coronary Intervention(DAP [mGycm^2] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.)
- Cumulative Air-Kerma (AK) of Percutaneous Coronary Intervention(AK [mGy] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.)
- Total Fluoroscopy Time of Percutaneous Coronary Intervention(Fluoroscopy time [minutes] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.)
- Procedure Efficiency(Patients will be followed from start of interventional procedure (vascular access obtained) until end of the procedure (vascular closure), ranging between 30 minutes and a few hours.)
研究者
研究点 (1)
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