NCT04343196

Digital Variance Angiography in Diagnostic Angiographies for Effective Radiation Dose Reduction

Application of Digital Variance Angiography in Diagnostic Lower Limb Angiographiy for Radiation Exposure Reduction a Prospective Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Kinepict Health Ltd. · Network
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease
• Peripheral Artery Disease
• Femoral Artery Stenosis
• Femoral Artery Occlusion
• Popliteal Stenosis
• Iliac Artery Stenosis
• Crural Artery Thrombosis
• Limb Ischemia

Interventions

Type	Name	Description
RADIATION	Diagnostic Angiography (DSA or DVA based on randomization result)	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

Timeline

• Start date: 2020-04-21
• Primary completion: 2020-09-30
• Completion: 2020-10-30
• First posted: 2020-04-13
• Last updated: 2021-09-13

Locations

1 site across 1 country: Hungary