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Completed

NCT Number: NCT04343196

Digital Variance Angiography in Diagnostic Angiographies for Effective Radiation Dose Reduction

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Crural Artery Thrombosis Femoral Artery Occlusion Femoral Artery Stenosis Iliac Artery Stenosis Limb Ischemia Peripheral Artery Disease Peripheral Vascular Diseases Popliteal Stenosis Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University, Heart and Vascular Center

Budapest, 1122, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Total procedural Dose-area product(DAP)

    Time frame: During the procedure

    Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2)

  2. Total DSA-related DAP

    Time frame: During the procedure

    Radiation load of the patient during DSA image acquistion (microGy*cm2 or Gy*cm2)

  3. Image quality review

    Time frame: 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.

  4. TASC classification

    Time frame: 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 outcomes

  1. Contrast media usage

    Time frame: During the procedure

    The volume of the iodinated contrast agent used for enhancing the image quality (mL)

  2. Number of protocol change

    Time frame: 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.

  3. Procedure time

    Time frame: During the procedure

    Duration of the whole procedure, from radial artery puncture till the removal of every tool (min).

Sponsors and collaborators

Lead sponsor

Kinepict Health Ltd.

Network

Collaborators

  • Semmelweis University Heart and Vascular Center

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2020
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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