Application of Digital Variance Angiography in Diagnostic Lower Limb Angiographiy for Radiation Exposure Reduction a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- TASC classification
研究概览
简要总结
Digital Variance Angiography (DVA) is a new tool in medical imaging with proven image quality reserve.
The previously observed quality reserve of Digital Variance Angiography (DVA) in lower extremity angiographies, allowed to lower radiation exposure by 70 % during DSA in lower extremity diagnostic angiographies with non-inferior image quality.
The aim of this study is to apply this non-inferior image quality and use it for radiation exposure reduction in diagnostic lower limb angiography.
The project would prospectively block-randomise (50:50) patients, who undergo elective diagnostic angiography into two groups: a comparator group examined by means of conventional DSA using a standard care protocol (Siemens Artis Zee, Extremities Care setting, 1.2 µGy/frame) (Group B) and a study group examined by means of DVA using a low-dose protocol (0.36 µGy/frame corresponding to 70% decrease of radiation dose) (Group A). During each procedure the investigators record radiation exposure (cumulative dosage, dose area product) and contrast media usage and procedural time then compare the results of the groups. Qualitative image review is done to compare conventional DSA and reduced radiation exposure DVA images after image acquisition.
Our hypothesis is that with the previously proven non-inferior image quality, the investigators will be able to reduce radiation exposure of the participants and also staff members in everyday clinical practice.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with lower limb peripheral arterial disease, admitted for diagnostic angiography
- •Fontaine II- IV
- •Normal renal function: GFR> 60ml/min/m2
- •Age > 18
排除标准
- •Acute myocardial infarction
- •Severe heart/liver/renal failure
- •Iodine contrast allergy
- •Atrioventricular block
- •Coagulopathy and Hematological Bleeding Disorders
结局指标
主要结局
TASC classification
时间窗: Upon completion of enrollment, approximately 1-year period
Blinded, anonymised and randomised review of images by multiple endovascular specialists. Clinically relevant sides for each patient are reviewed in a separate questionnaire: each reviewer have to classify each patient's angiographic image according to the Trans-Atlantic Inter-Society Consensus Document's second version.
Total procedural Dose-area product(DAP)
时间窗: During the procedure
Indicator of a patient's irradiation dosage (microGy\*cm2 or Gy\*cm2)
Total DSA-related DAP
时间窗: During the procedure
Radiation load of the patient during DSA image acquistion (microGy\*cm2 or Gy\*cm2)
Image quality review
时间窗: Upon completion of enrollment, approximately 1-year period
Blinded, anonymised and randomised qualitative review and comparison of images by multiple endovascular specialists in multiple regions using a 1-5 Likert-scale for each image. Region specific scores are compared between DSA and DVA technique.
次要结局
- Procedure time(During the procedure)
- Contrast media usage(During the procedure)
- Number of protocol change(During the procedure)