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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Peripheral Artery Disease; Femoral Artery Occlusion; Iliac Artery Stenosis; Limb Ischemia; Femoral Artery Stenosis; Popliteal Stenosis; Crural Artery Thrombosis
• Intervention / Treatment: Radiation: Diagnostic Angiography (DSA or DVA based on randomization result)

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis University, Heart and Vascular Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with lower limb peripheral arterial disease, admitted for diagnostic angiography
• Fontaine II- IV
• Normal renal function: GFR> 60ml/min/m2
• Age > 18

Exclusion Criteria:

• Acute myocardial infarction
• Severe heart/liver/renal failure
• Iodine contrast allergy
• Atrioventricular block
• Coagulopathy and Hematological Bleeding Disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Low-dose DVA group; Image acquisition at a reduced X-ray dose, 0.36 µGy/frame (70% reduction) image processing by DVA	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
Active Comparator: Group B: Normal-dose DSA group; Image acquisition at a normal dose (1.2 µGy/frame) image processing by DSA	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total procedural Dose-area product(DAP)	Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2)	During the procedure
Total DSA-related DAP	Radiation load of the patient during DSA image acquistion (microGy*cm2 or Gy*cm2)	During the procedure
Image quality review	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.	Upon completion of enrollment, approximately 1-year period
TASC classification	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.	Upon completion of enrollment, approximately 1-year period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast media usage	The volume of the iodinated contrast agent used for enhancing the image quality (mL)	During the procedure
Number of protocol change	The number of occasions when the reduced radiation level protocol has to be switched back to conventional protocol in one region because of unsuitable image quality.	During the procedure
Procedure time	Duration of the whole procedure, from radial artery puncture till the removal of every tool (min).	During the procedure

Collaborators and Investigators

• Sponsor: Kinepict Health Ltd.
• Collaborators: Semmelweis University Heart and Vascular Center
• Investigators: Study Chair: Krisztián Szigeti, Ph.D., Kinepict Health Ltd.; Study Chair: Szabolcs Osváth, Ph.D., Kinepict Health Ltd.; Study Chair: János Kiss, M.D.,Ph.D.,D.Sc., Kinepict Health Ltd.

Publications and helpful links

General Publications

• Orias VI, Gyano M, Gog I, Szollosi D, Veres DS, Nagy Z, Csobay-Novak C, Zoltan O, Kiss JP, Osvath S, Szigeti K, Zoltan R, Sotonyi P. Digital Variance Angiography as a Paradigm Shift in Carbon Dioxide Angiography. Invest Radiol. 2019 Jul;54(7):428-436. doi: 10.1097/RLI.0000000000000555.
• Gyano M, Gog I, Orias VI, Ruzsa Z, Nemes B, Csobay-Novak C, Olah Z, Nagy Z, Merkely B, Szigeti K, Osvath S, Sotonyi P. Kinetic Imaging in Lower Extremity Arteriography: Comparison to Digital Subtraction Angiography. Radiology. 2019 Jan;290(1):246-253. doi: 10.1148/radiol.2018172927. Epub 2018 Oct 16.

Helpful Links

• Homepage for the Kinepict scientific group, source for additional information about digital variance angiography

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2020
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Radiation exposure; Peripheral Arterial Disease; Digital Subtraction Angiography; Image quality; Radiation protection; X-ray angiography; Digital Variance Angiography; Kinepict; Image acquistion
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Embolism and Thrombosis; Atherosclerosis; Pathological Conditions, Anatomical; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases; Thrombosis; Constriction, Pathologic
• Other Study ID Numbers: Kinepict-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No