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

• Sponsor: Kinepict Health Ltd. (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04792255
• Collaborator: Semmelweis University (Other), Bács-Kiskun County Teaching Hospital (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.9
• Patients Per Site Per Month: 11.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Diseases	Procedure: Carotid artery stenting with standard contrast media protocol; Procedure: Carotid artery stenting with reduced contrast media protocol; Diagnostic Test: Carotid Duplex Ultrasound	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Feb 28, 2023

Arms and Interventions

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: Arterial access Preinterventional selective carotid artery angiography Carotid artery stenting 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.	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: Arterial access Preinterventional selective carotid artery angiography Carotid artery stenting Postinterventional selective carotid artery angiography ; Diagnostic Test: Carotid Duplex Ultrasound; Pre- and postinterventional assessment of the treated internal carotid artery.

Outcome Measures

Primary Outcome Measures

1. DSA-related contrast media use [During the procedure]

   Volume of the iodinated contrast agent used for enhancing the image quality (mL)

2. Total procedural contrast media use [During the procedure]

   Volume of the iodinated contrast agent used for enhancing the image quality (mL)

3. Image quality, graded by independent observers [through study completion, an average of 1 year]

   Observations based on a 5-level Likert scale (1-poor image quality, 3-medium image quality, 5-outstanding image quality)

Secondary Outcome Measures

1. Total procedural dose area product [During the procedure]

   Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2)

2. DSA-related dose area product [During the procedure]

   Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2)

3. Total procedural time [During the procedure]

   Duration of the whole procedure, from arterial access till the removal of every tool (min)

4. Number of protocol changes during DVA usage [During the procedure]

   Number of occasions when the reduced contrast media protocol has to be switched back to conventional protocol because of the unsuitable image quality

5. Residual stenosis [During the procedure]

   The difference between the normal reference segment diameter and the minimum lumen diameter of the treated lesion after CAS (%)

6. Focal neurological symptoms [During the procedure and up to 1 day]

   Focal neurological symptoms ipsilateral to the treated carotid artery during the postprocedural observation period

7. Preoperative and postoperative ipsilateral carotid artery flow by doppler ultrasound [Preoperatively and 1 day after the procedure]

   Peak-systolic and end-diastolic velocities (cm/sec)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Semmelweis University, Heart and Vascular Center	Budapest		Hungary	1122

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Gyánó M, Góg I, Óriás VI, Ruzsa Z, Nemes B, Csobay-Novák C, Oláh Z, Nagy Z, Merkely B, Szigeti K, Osváth S, Sótonyi 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.
• Óriás VI, Gyánó M, Góg I, Szöllősi D, Veres DS, Nagy Z, Csobay-Novák C, Zoltán O, Kiss JP, Osváth S, Szigeti K, Zoltán R, Sótonyi 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.
• Óriás VI, Szöllősi D, Gyánó M, Veres DS, Nardai S, Csobay-Novák C, Nemes B, Kiss JP, Szigeti K, Osváth S, Sótonyi 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.

• Responsible Party: Kinepict Health Ltd.
• ClinicalTrials.gov Identifier: NCT04792255
• Other Study ID Numbers: Kinepict-009
• First Posted: Mar 10, 2021
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Kinepict Health Ltd.: Radiocontrast media reduction; X-ray angiography; Digital Variance Angiography; Digital Subtraction Angiography; carotid artery stenting; Kinepict
• Additional relevant MeSH terms: Carotid Artery Diseases

Study Results

No Results Posted as of Jul 13, 2022