Digital Variance Angiography in Diagnostic Angiographies for Effective Radiation Dose Reduction

Sponsor

Kinepict Health Ltd. (Other)

Overall Status

Completed

CT.gov ID

NCT04343196

Collaborator

Semmelweis University Heart and Vascular Center (Other)

114

Enrollment

Location

Arms

6.3

Actual Duration (Months)

18.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease Peripheral Artery Disease Femoral Artery Stenosis Femoral Artery Occlusion Popliteal Stenosis Iliac Artery Stenosis Crural Artery Thrombosis Limb Ischemia	Radiation: Diagnostic Angiography (DSA or DVA based on randomization result)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 21, 2020

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Oct 30, 2020

Arms and Interventions

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

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)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Contrast media usage [During the procedure]
The volume of the iodinated contrast agent used for enhancing the image quality (mL)
Number of protocol change [During the procedure]
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.
Procedure time [During the procedure]
Duration of the whole procedure, from radial artery puncture till the removal of every tool (min).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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