Digital Variance Angiography for Contrast Media Dose Reduction in Carotid Artery Stenting

Carotid Artery Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04792255
• Other study ID #: Kinepict-009
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Kinepict Health Ltd.
• Contact: Péter Sótonyi, MD, PhD
• Phone: +36 20 825 8046
• Email: sotonyi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Diseases

Intervention

Procedure:
• Carotid artery stenting with standard contrast media protocol
Radial, brachial or femoral arterial access is gained by using the Seldinger technique. The common carotid artery (CCA) is catheterized. Selective angiography is performed from the anteroposterior and lateral view without magnification. Initial angiograms are performed with standard contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the common carotid artery. The carotid arterial lesion is crossed and an embolic protection device is deployed in the internal carotid artery. Carotid artery stenting is performed in a standard fashion. Post-stenting angiographies are obtained with the standard contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the CCA. Pre- and post-stenting angiographies are performed with the same sheath position. DSA and DVA images will be calculated on a commercially available image processing workstation and the Kinepict Medical Imaging Tool.
• Carotid artery stenting with reduced contrast media protocol
Radial, brachial or femoral arterial access is gained by using the Seldinger technique. The common carotid artery (CCA) is catheterized. Selective angiography is performed from the anteroposterior and lateral view without magnification. Initial angiograms are performed with the reduced contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the common carotid artery. The carotid arterial lesion is crossed and an embolic protection device is deployed in the internal carotid artery. Carotid artery stenting is performed in a standard fashion. Post-stenting angiographies are obtained with the reduced contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the CCA. Pre- and post-stenting angiographies are performed with the same sheath position. DSA and DVA images will be calculated on a commercially available image processing workstation and the Kinepict Medical Imaging Tool.

Diagnostic Test:
• Carotid Duplex Ultrasound
Pre- and postinterventional assessment of the treated internal carotid artery.

Locations

Country	Name	City	State
Hungary	Semmelweis University, Heart and Vascular Center	Budapest

Sponsors (3)

Lead Sponsor	Collaborator
Kinepict Health Ltd.	Bács-Kiskun County Teaching Hospital, Semmelweis University

Country where clinical trial is conducted

Hungary, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DSA-related contrast media use	Volume of the iodinated contrast agent used for enhancing the image quality (mL)	During the procedure
Primary	Total procedural contrast media use	Volume of the iodinated contrast agent used for enhancing the image quality (mL)	During the procedure
Primary	Image quality, graded by independent observers	Observations based on a 5-level Likert scale (1-poor image quality, 3-medium image quality, 5-outstanding image quality)	through study completion, an average of 1 year
Secondary	Total procedural dose area product	Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2)	During the procedure
Secondary	DSA-related dose area product	Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2)	During the procedure
Secondary	Total procedural time	Duration of the whole procedure, from arterial access till the removal of every tool (min)	During the procedure
Secondary	Number of protocol changes during DVA usage	Number of occasions when the reduced contrast media protocol has to be switched back to conventional protocol because of the unsuitable image quality	During the procedure
Secondary	Residual stenosis	The difference between the normal reference segment diameter and the minimum lumen diameter of the treated lesion after CAS (%)	During the procedure
Secondary	Focal neurological symptoms	Focal neurological symptoms ipsilateral to the treated carotid artery during the postprocedural observation period	During the procedure and up to 1 day
Secondary	Preoperative and postoperative ipsilateral carotid artery flow by doppler ultrasound	Peak-systolic and end-diastolic velocities (cm/sec)	Preoperatively and 1 day after the procedure