Clinical trial NCT04792255: Digital Variance Angiography for Contrast Media Dose Reduction in Carotid Artery Stenting
Official title: Investigation of Dose Management Capabilities of Digital Variance Angiography: Contrast Media Dose Reduction in Patients Undergoing Carotid Artery Stenting - a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carotid Artery Diseases
Keywords: Radiocontrast media reduction
X-ray angiography
Digital Variance Angiography
Digital Subtraction Angiography
carotid artery stenting
Kinepict
Lead sponsor: Kinepict Health Ltd.
Sponsor class: NETWORK
Collaborators: name: Semmelweis University
name: Bács-Kiskun County Teaching Hospital
First posted: 2021-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrolled participants will undergo carotid artery stenting with different image acquisition protocol of the pre-and postinterventional angiographies from anteroposterior and lateral views, and intraoperative angiographies with C-arm angulations based on the operator's decision. In the active comparator group, a standard contrast media dose and DSA images will be used for diagnosis whereas in the experimental group a reduced contrast media dose will be applied (50% decrease compared to the standard DSA protocol) and the operator will use DVA images for the diagnosis.
Primary purpose: OTHER

Brief summary: Digital Variance Angiography (DVA) is a new tool in medical imaging with a proven image quality reserve (1, 2).

Previous studies have demonstrated the quality reserve of DVA in angiographic studies (1, 2), which allowed us to reduce contrast media use by 50% in carotid artery angiographic studies without affecting the image quality (3).

CAS is an alternative treatment option for carotid artery revascularization in selected patient groups. Similar to most of the minimally invasive endovascular interventions, CAS also carries the risk of contrast-induced acute kidney injury, which is considered to be an independent predictor of 30-day major adverse events (4).

The aim of this study is to apply DVA in patients undergoing carotid artery stenting (CAS) and utilize this technique to reduce contrast dose during the interventions, without affecting the intraprocedural radiation dose and the clinical outcome of the procedures. Investigators believe that the reduction in contrast media use and the associated image quality with the technique of DVA imaging can be incorporated into the everyday clinical practice, and will play an important role in improving the rate of contrast-induced acute kidney injury.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 y
* Carotid stenosis defined as:

Stenosis ≥70% by computer tomography angiography (NASCET criteria); OR by duplex-ultrasound with ≥70% stenosis defined by a peak systolic velocity of at least 230 cm/s

* Carotid stenosis is treatable with CAS

Exclusion Criteria:

* History of stroke or TIA ipsilateral to the stenosis within 30 days of randomization
* Acute myocardial infarction
* Severe chronic kidney disease: GFR\>30ml/min/m2
* Severe heart failure: NYHA IV
* Severe liver failure: Child-Pugh 3
* Iodine contrast allergy
* Coagulopathy
* Hematological bleeding disorders

Primary outcomes:
measure: DSA-related contrast media use
timeFrame: During the procedure
measure: Total procedural contrast media use
timeFrame: During the procedure
measure: Image quality, graded by independent observers
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Total procedural dose area product
timeFrame: During the procedure
measure: DSA-related dose area product
timeFrame: During the procedure
measure: Total procedural time
timeFrame: During the procedure
measure: Number of protocol changes during DVA usage
timeFrame: During the procedure
measure: Residual stenosis
timeFrame: During the procedure
measure: Focal neurological symptoms
timeFrame: During the procedure and up to 1 day
measure: Preoperative and postoperative ipsilateral carotid artery flow by doppler ultrasound
timeFrame: Preoperatively and 1 day after the procedure
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Heart and Vascular Center
Study officials:
References:
citation: 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.
citation: 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.
citation: Orias VI, Szollosi D, Gyano M, Veres DS, Nardai S, Csobay-Novak C, Nemes B, Kiss JP, Szigeti K, Osvath S, Sotonyi P, Ruzsa Z. Initial evidence of a 50% reduction of contrast media using digital variance angiography in endovascular carotid interventions. Eur J Radiol Open. 2020 Nov 17;7:100288. doi: 10.1016/j.ejro.2020.100288. eCollection 2020.
citation: Paraskevas KI, Mikhailidis DP. Contrast-Induced Acute Kidney Injury in Patients Undergoing Carotid Artery Stenting: An Underestimated Issue. Angiology. 2017 Oct;68(9):752-756. doi: 10.1177/0003319716668934. Epub 2016 Sep 19.