An interventional study of Diagnostic Angiography (DSA or DVA based on randomization result) in Peripheral Arterial Disease, Peripheral Artery Disease and Femoral Artery Stenosis, sponsored by Kinepict Health Ltd.. Completed at 1 site in Hungary. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-09-13.
Sponsored by Kinepict Health Ltd. · Not applicable, Interventional, and Other
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.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 114 is close to the median of 106 across 849 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →Kinepict Health Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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)
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
Total procedural Dose-area product(DAP)
Indicator of a patient's irradiation dosage (microGy\*cm2 or Gy\*cm2)
Time frame: During the procedure
Total DSA-related DAP
Radiation load of the patient during DSA image acquistion (microGy\*cm2 or Gy\*cm2)
Time frame: 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.
Time frame: 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.
Time frame: Upon completion of enrollment, approximately 1-year period
Contrast media usage
The volume of the iodinated contrast agent used for enhancing the image quality (mL)
Time frame: 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.
Time frame: During the procedure
Procedure time
Duration of the whole procedure, from radial artery puncture till the removal of every tool (min).
Time frame: During the procedure
Plan to share: No
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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