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 Details — Status: Completed

Administrative data

• NCT number: NCT04343196
• Other study ID #: Kinepict-008
• Status: Completed
• Phase: N/A
• Start date: April 21, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: September 2021
• Source: Kinepict Health Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Crural Artery Thrombosis
• Femoral Artery Occlusion
• Femoral Artery Stenosis
• Iliac Artery Stenosis
• Ischemia
• Limb Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Diseases
• Popliteal Stenosis
• Thrombosis

Intervention

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

Locations

Country	Name	City	State
Hungary	Semmelweis University, Heart and Vascular Center	Budapest

Sponsors (2)

Lead Sponsor	Collaborator
Kinepict Health Ltd.	Semmelweis University Heart and Vascular Center

Country where clinical trial is conducted

Hungary, 

References & Publications (2)

Gyánó M, Góg I, Óriás VI, Ruzsa Z, Nemes B, Csobay-Novák C, Oláh Z, Nagy Z, Merkely B, Szigeti K, Osváth S, Sótonyi 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. — View Citation

Óriás VI, Gyánó M, Góg I, Szöllosi D, Veres DS, Nagy Z, Csobay-Novák C, Zoltán O, Kiss JP, Osváth S, Szigeti K, Zoltán R, Sótonyi 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total procedural Dose-area product(DAP)	Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2)	During the procedure
Primary	Total DSA-related DAP	Radiation load of the patient during DSA image acquistion (microGy*cm2 or Gy*cm2)	During the procedure
Primary	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
Primary	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	Contrast media usage	The volume of the iodinated contrast agent used for enhancing the image quality (mL)	During the procedure
Secondary	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
Secondary	Procedure time	Duration of the whole procedure, from radial artery puncture till the removal of every tool (min).	During the procedure

External Links

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