Digital Variance Angiography in Diagnostic Angiographies for Effective Radiation Dose Reduction

NCT04343196 | Completed

• 1 other identifier: Kinepict-008
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Radiation protection; X-ray angiography; Digital Variance Angiography; Digital Subtraction Angiography; Peripheral Arterial Disease; Kinepict; Image acquistion; Image quality; Radiation exposure

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Contrast media usage

  During the procedure

• Number of protocol change

  During the procedure

• Procedure time

  During the procedure

Study Arms (2)

Group A: Low-dose DVA group

EXPERIMENTAL

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)

Group B: Normal-dose DSA group

ACTIVE COMPARATOR

Image acquisition at a normal dose (1.2 µGy/frame) image processing by DSA

Radiation: Diagnostic Angiography (DSA or DVA based on randomization result)

Interventions

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

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

Group A: Low-dose DVA group; Group B: Normal-dose DSA group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kinepict Health Ltd.: lead
• Semmelweis University Heart and Vascular Center: collaborator

Study Sites (1)

Semmelweis University, Heart and Vascular Center

Budapest, 1122, Hungary

Location

Related Publications (2)

• 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.

  PMID: 30829769 BACKGROUND

• 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.

  PMID: 30325284 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• 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.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 13, 2020
• Study Start: April 21, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 30, 2020
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)