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

Primary Purpose

Carotid Artery Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Carotid artery stenting with standard contrast media protocol
Carotid artery stenting with reduced contrast media protocol
Carotid Duplex Ultrasound
Sponsored by
Kinepict Health Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Carotid Artery Diseases focused on measuring Radiocontrast media reduction, X-ray angiography, Digital Variance Angiography, Digital Subtraction Angiography, carotid artery stenting, Kinepict

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Semmelweis University, Heart and Vascular CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A: Reduced contrast media dose group

Group B: Standard contrast media dose group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

DSA-related contrast media use
Volume of the iodinated contrast agent used for enhancing the image quality (mL)
Total procedural contrast media use
Volume of the iodinated contrast agent used for enhancing the image quality (mL)
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)

Secondary Outcome Measures

Total procedural dose area product
Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2)
DSA-related dose area product
Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2)
Total procedural time
Duration of the whole procedure, from arterial access till the removal of every tool (min)
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
Residual stenosis
The difference between the normal reference segment diameter and the minimum lumen diameter of the treated lesion after CAS (%)
Focal neurological symptoms
Focal neurological symptoms ipsilateral to the treated carotid artery during the postprocedural observation period
Preoperative and postoperative ipsilateral carotid artery flow by doppler ultrasound
Peak-systolic and end-diastolic velocities (cm/sec)

Full Information

First Posted
February 23, 2021
Last Updated
March 8, 2023
Sponsor
Kinepict Health Ltd.
Collaborators
Semmelweis University, Bács-Kiskun County Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04792255
Brief Title
Digital Variance Angiography for Contrast Media Dose Reduction in Carotid Artery Stenting
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kinepict Health Ltd.
Collaborators
Semmelweis University, Bács-Kiskun County Teaching Hospital

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Diseases
Keywords
Radiocontrast media reduction, X-ray angiography, Digital Variance Angiography, Digital Subtraction Angiography, carotid artery stenting, Kinepict

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Reduced contrast media dose group
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B: Standard contrast media dose group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Carotid artery stenting with standard contrast media protocol
Other Intervention Name(s)
Arterial access, Preinterventional selective carotid artery angiography, Carotid artery stenting, Postinterventional selective carotid artery angiography
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Carotid artery stenting with reduced contrast media protocol
Other Intervention Name(s)
Arterial access, Preinterventional selective carotid artery angiography, Carotid artery stenting, Postinterventional selective carotid artery angiography
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Carotid Duplex Ultrasound
Intervention Description
Pre- and postinterventional assessment of the treated internal carotid artery.
Primary Outcome Measure Information:
Title
DSA-related contrast media use
Description
Volume of the iodinated contrast agent used for enhancing the image quality (mL)
Time Frame
During the procedure
Title
Total procedural contrast media use
Description
Volume of the iodinated contrast agent used for enhancing the image quality (mL)
Time Frame
During the procedure
Title
Image quality, graded by independent observers
Description
Observations based on a 5-level Likert scale (1-poor image quality, 3-medium image quality, 5-outstanding image quality)
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Total procedural dose area product
Description
Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2)
Time Frame
During the procedure
Title
DSA-related dose area product
Description
Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2)
Time Frame
During the procedure
Title
Total procedural time
Description
Duration of the whole procedure, from arterial access till the removal of every tool (min)
Time Frame
During the procedure
Title
Number of protocol changes during DVA usage
Description
Number of occasions when the reduced contrast media protocol has to be switched back to conventional protocol because of the unsuitable image quality
Time Frame
During the procedure
Title
Residual stenosis
Description
The difference between the normal reference segment diameter and the minimum lumen diameter of the treated lesion after CAS (%)
Time Frame
During the procedure
Title
Focal neurological symptoms
Description
Focal neurological symptoms ipsilateral to the treated carotid artery during the postprocedural observation period
Time Frame
During the procedure and up to 1 day
Title
Preoperative and postoperative ipsilateral carotid artery flow by doppler ultrasound
Description
Peak-systolic and end-diastolic velocities (cm/sec)
Time Frame
Preoperatively and 1 day after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Péter Sótonyi, MD, PhD
Phone
+36 20 825 8046
Email
sotonyi@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Peter T Legeza, MD
Phone
+36 20 825 9736
Email
peterlegeza@gmail.com
Facility Information:
Facility Name
Semmelweis University, Heart and Vascular Center
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Péter Sótonyi, Prof,MD,PhD
First Name & Middle Initial & Last Name & Degree
Balázs Nemes, MD,PhD
First Name & Middle Initial & Last Name & Degree
Márton Berczeli, M.D.
First Name & Middle Initial & Last Name & Degree
Marcell Gyánó, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30325284
Citation
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.
Results Reference
background
PubMed Identifier
30829769
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.
Results Reference
background
PubMed Identifier
33294499
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.
Results Reference
background
PubMed Identifier
27645233
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.
Results Reference
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Digital Variance Angiography for Contrast Media Dose Reduction in Carotid Artery Stenting

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