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

NCT04792255 | Unknown

• 1 other identifier: Kinepict-009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Diseases

Keywords

Radiocontrast media reduction; X-ray angiography; Digital Variance Angiography; Digital Subtraction Angiography; carotid artery stenting; Kinepict

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Total procedural dose area product

  During the procedure

• DSA-related dose area product

  During the procedure

• Total procedural time

  During the procedure

• Number of protocol changes during DVA usage

  During the procedure

• Residual stenosis

  During the procedure

Study Arms (2)

Group A: Reduced contrast media dose group

EXPERIMENTAL

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; Diagnostic Test: Carotid Duplex Ultrasound

Group B: Standard contrast media dose group

ACTIVE COMPARATOR

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.

Procedure: Carotid artery stenting with standard contrast media protocol; Diagnostic Test: Carotid Duplex Ultrasound

Interventions

Carotid artery stenting with standard contrast media protocol PROCEDURE

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.

Also known as: Arterial access, Preinterventional selective carotid artery angiography, Carotid artery stenting, Postinterventional selective carotid artery angiography

Group B: Standard contrast media dose group

Carotid artery stenting with reduced contrast media protocol PROCEDURE

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.

Also known as: Arterial access, Preinterventional selective carotid artery angiography, Carotid artery stenting, Postinterventional selective carotid artery angiography

Group A: Reduced contrast media dose group

Carotid Duplex Ultrasound DIAGNOSTIC_TEST

Pre- and postinterventional assessment of the treated internal carotid artery.

Group A: Reduced contrast media dose group; Group B: Standard contrast media dose group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kinepict Health Ltd.: lead
• Semmelweis University: collaborator
• Bács-Kiskun County Teaching Hospital: collaborator

Study Sites (1)

Semmelweis University, Heart and Vascular Center

Budapest, 1122, Hungary

RECRUITING

Related 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.

  PMID: 30325284 BACKGROUND

• 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.

  PMID: 30829769 BACKGROUND

• 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.

  PMID: 33294499 BACKGROUND

• 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.

  PMID: 27645233 BACKGROUND

MeSH Terms

Conditions

Carotid Artery Diseases

Interventions

Vascular Access Devices

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Central Study Contacts

Péter Sótonyi, MD, PhD

CONTACT

+36 20 825 8046; sotonyi@hotmail.com

Peter T Legeza, MD

CONTACT

+36 20 825 9736; peterlegeza@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 10, 2021
• Study Start: June 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 9, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)