Digital Variance Angiography in Diagnostic Angiographies for Effective Radiation Dose Reduction
Condition: Peripheral Arterial Disease; Peripheral Artery Disease; Femoral Artery Stenosis; Femoral Artery Occlusion; Popliteal Stenosis; Iliac Artery Stenosis; Crural Artery Thrombosis; Limb Ischemia
MeSH terms: Thrombosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Constriction, Pathologic; Ischemia
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Diagnostic Angiography (DSA or DVA based on randomization result)
Intervention type(s): Radiation
Intervention description(s): After radial/brachial/femoral artery puncture using Seldinger technique, the investigators first position a pigtail catheter above the level of the renal arteries. With Siemens Artis Zee Pure DSA machine the examiner will use a postero-anterior X-ray view for the first image, which is an aortography of some part of the iliac system. Then, the catheter will be repositioned to the aortic bifurcation and 15-18 mL contrast media (CM) with 9-10 mL/s flow for the ilio-femoral region will be injected. All of the following image series will be made from this catheter position, with a 9 mL/s flow rate. In cases for when the recorded image series will be inconclusive, image series with left/right oblique position will be recorded. All femoro-popliteal images will be recorded with 10-16 ml CM and crural regions with 12-22mml. DSA images will be calculated from all series on a dedicated Syngo workstation and used for diagnosis. DVA images will be calculated by the Kinepict Medical Imaging Tool
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All enrolled participants will undergo a diagnostic lower limb angiography, but the image acquisition protocol will be different. In the active comparator group a normal radiation dose will be used and the DSA images will be used for diagnosis whereas in the experimental group a low dose radiation will be applied (70% decrease compared tot he DSA protocol) and the DVA images will be used for diagnosis.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Radiation protection; X-ray angiography; Digital Variance Angiography; Digital Subtraction Angiography; Peripheral Arterial Disease; Kinepict; Image acquistion; Image quality; Radiation exposure