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Digital Variance Angiography in Diagnostic Angiographies for Effective Radiation Dose Reduction

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04343196
Study type Interventional
Source Kinepict Health Ltd.
Contact
Status Completed
Phase N/A
Start date April 21, 2020
Completion date October 30, 2020
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