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

Kinepict

Status: Enrolling

Conditions: Carotid Artery Diseases

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

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04792255

Kinepict-009

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group A: Reduced contrast media dose group

Experimental group

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.

Treatment:

Procedure: Carotid artery stenting with reduced contrast media protocol

Diagnostic Test: Carotid Duplex Ultrasound

Group B: Standard contrast media dose group

Active Comparator group

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.

Treatment:

Procedure: Carotid artery stenting with standard contrast media protocol

Diagnostic Test: Carotid Duplex Ultrasound