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Peripheral Arterial DiseaseNCT04343196

Digital Variance Angiography in Diagnostic Angiographies for Effective Radiation Dose Reduction

A study testing Diagnostic Angiography (DSA or DVA based on randomization result) in people with Peripheral Arterial Disease and Peripheral Artery Disease, run by Kinepict Health Ltd. at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Diagnostic Angiography (DSA or DVA based on randomization result)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteHungary
Study dates
21 Apr 2020to 30 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hungary1 site

  • Semmelweis University, Heart and Vascular Center

    Budapest, 1122

Other trials in Hungary

About this study

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

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.

Read more

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.

Being tested
Diagnostic Angiography (DSA or DVA based on randomization result)
Keywords
Radiation protection, X-ray angiography, Digital Variance Angiography, Digital Subtraction Angiography, Peripheral Arterial Disease, Kinepict, Image acquistion, Image quality, Radiation exposure
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT04343196
Study groupRoleWhat they receive
Group A: Low-dose DVA groupExperimentalImage acquisition at a reduced X-ray dose, 0.36 µGy/frame (70% reduction) image processing by DVA
Receives: Radiation: Diagnostic Angiography (DSA or DVA based on randomization result)
Group B: Normal-dose DSA groupActive comparatorImage acquisition at a normal dose (1.2 µGy/frame) image processing by DSA
Receives: Radiation: Diagnostic Angiography (DSA or DVA based on randomization result)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total procedural Dose-area product(DAP)

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

    Measured: During the procedure

  2. Total DSA-related DAP

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

    Measured: During the procedure

  3. 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.

    Measured: Upon completion of enrollment, approximately 1-year period

  4. 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.

    Measured: Upon completion of enrollment, approximately 1-year period

Secondary outcomes (3)

  1. Contrast media usage

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

    Measured: During the procedure

  2. 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.

    Measured: During the procedure

  3. Procedure time

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

    Measured: During the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2020
  2. Study start21 Apr 2020
  3. Primary completion30 Sep 2020
  4. Study completion30 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04343196
Sponsor's protocol ID
Kinepict-008
Status last verified
Sep 2021
First submitted
6 Apr 2020
Last updated
13 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30829769

  • 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.

    PubMed 30325284

Questions about this trial

What is this clinical trial studying?

A study testing Diagnostic Angiography (DSA or DVA based on randomization result) in people with Peripheral Arterial Disease and Peripheral Artery Disease, run by Kinepict Health Ltd. at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total procedural Dose-area product(DAP) (time frame: During the procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04343196, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.

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