NCT04792255

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

Investigation of Dose Management Capabilities of Digital Variance Angiography: Contrast Media Dose Reduction in Patients Undergoing Carotid Artery Stenting - a Prospective Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kinepict Health Ltd. · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carotid Artery Diseases

Interventions

Type	Name	Description
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.
PROCEDURE	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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2021-03-10
• Last updated: 2023-03-09

Locations

1 site across 1 country: Hungary