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

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.

Study Overview

• Status: Recruiting
• Conditions: Carotid Artery Diseases
• Intervention / Treatment: Procedure: Carotid artery stenting with reduced contrast media protocol; Diagnostic test: Carotid Duplex Ultrasound; Procedure: Carotid artery stenting with standard contrast media protocol

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Péter Sótonyi, MD, PhD; Phone Number: +36 20 825 8046; Email: sotonyi@hotmail.com
• Study Contact Backup: Name: Peter T Legeza, MD; Phone Number: +36 20 825 9736; Email: peterlegeza@gmail.com

Study Locations

• Hungary
  • Budapest, Hungary, 1122
    • Recruiting
    • Semmelweis University, Heart and Vascular Center
    • Contact: Péter Sótonyi, Prof,MD,PhD
    • Contact: Balázs Nemes, MD,PhD
    • Sub-Investigator: Márton Berczeli, M.D.
    • Sub-Investigator: Marcell Gyánó, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Reduced contrast media dose group; Reduced contrast media protocol: extracranial carotid artery intervention (2-4 fps according to the institutional protocol). Contrast administration with an automatic contrast injector: angiographic image acquisitions will be performed with 6 ml of 50% contrast media (3 ml iodined contrast media, 3 ml physiologic saline) with a 3 ml/s flow rate. DSA and DVA images will be calculated; DVA images will be used for diagnosis and interventions.	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.; Other Names: Carotid artery stenting; Arterial access; Preinterventional selective carotid artery angiography; Postinterventional selective carotid artery angiography; Diagnostic test: Carotid Duplex Ultrasound; Pre- and postinterventional assessment of the treated internal carotid artery.
Active Comparator: Group B: Standard contrast media dose group; Standard contrast media protocol: extracranial carotid artery intervention (2-4 fps according to the institutional protocol). Contrast administration with an automatic contrast injector: angiographic image acquisitions will be performed with 6 ml iodined contrast media with a 3 ml/s flow rate. DSA and DVA images will be calculated; DSA images will be used for diagnosis and interventions.	Diagnostic test: Carotid Duplex Ultrasound; Pre- and postinterventional assessment of the treated internal carotid artery.; 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.; Other Names: Carotid artery stenting; Arterial access; Preinterventional selective carotid artery angiography; Postinterventional selective carotid artery angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DSA-related contrast media use	Volume of the iodinated contrast agent used for enhancing the image quality (mL)	During the procedure
Total procedural contrast media use	Volume of the iodinated contrast agent used for enhancing the image quality (mL)	During the procedure
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total procedural dose area product	Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2)	During the procedure
DSA-related dose area product	Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2)	During the procedure
Total procedural time	Duration of the whole procedure, from arterial access till the removal of every tool (min)	During the procedure
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
Residual stenosis	The difference between the normal reference segment diameter and the minimum lumen diameter of the treated lesion after CAS (%)	During the procedure
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
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

Collaborators and Investigators

• Sponsor: Kinepict Health Ltd.
• Collaborators: Semmelweis University; Bács-Kiskun County Teaching Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Digital Subtraction Angiography; carotid artery stenting; X-ray angiography; Digital Variance Angiography; Kinepict; Radiocontrast media reduction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carotid Artery Diseases
• Other Study ID Numbers: Kinepict-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No