Digital Variance Angiography for Contrast Media Dose Reduction in Carotid Artery Stenting
- Conditions
- Carotid Artery Diseases
- Interventions
- Procedure: Carotid artery stenting with standard contrast media protocolProcedure: Carotid artery stenting with reduced contrast media protocolDiagnostic Test: Carotid Duplex Ultrasound
- Registration Number
- NCT04792255
- Lead Sponsor
- Kinepict Health Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B: Standard contrast media dose group Carotid Duplex Ultrasound 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. Group A: Reduced contrast media dose group Carotid Duplex Ultrasound 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. Group B: Standard contrast media dose group Carotid artery stenting with standard contrast media protocol 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. Group A: Reduced contrast media dose group Carotid artery stenting with reduced contrast media protocol 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.
- Primary Outcome Measures
Name Time Method DSA-related contrast media use During the procedure Volume of the iodinated contrast agent used for enhancing the image quality (mL)
Total procedural contrast media use During the procedure Volume of the iodinated contrast agent used for enhancing the image quality (mL)
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
Name Time Method Residual stenosis During the procedure The difference between the normal reference segment diameter and the minimum lumen diameter of the treated lesion after CAS (%)
DSA-related dose area product During the procedure Indicator of a patient's irradiation dosage (microGy\*cm2 or Gy\*cm2)
Total procedural time During the procedure Duration of the whole procedure, from arterial access till the removal of every tool (min)
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
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
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)
Total procedural dose area product During the procedure Indicator of a patient's irradiation dosage (microGy\*cm2 or Gy\*cm2)
Trial Locations
- Locations (1)
Semmelweis University, Heart and Vascular Center
🇭🇺Budapest, Hungary