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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
100
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.
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.
Pre- and postinterventional assessment of the treated internal carotid artery.
Semmelweis University, Heart and Vascular Center
Budapest, Hungary
RECRUITINGDSA-related contrast media use
Volume of the iodinated contrast agent used for enhancing the image quality (mL)
Time frame: During the procedure
Total procedural contrast media use
Volume of the iodinated contrast agent used for enhancing the image quality (mL)
Time frame: 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)
Time frame: through study completion, an average of 1 year
Total procedural dose area product
Indicator of a patient's irradiation dosage (microGy\*cm2 or Gy\*cm2)
Time frame: During the procedure
DSA-related dose area product
Indicator of a patient's irradiation dosage (microGy\*cm2 or Gy\*cm2)
Time frame: During the procedure
Total procedural time
Duration of the whole procedure, from arterial access till the removal of every tool (min)
Time frame: During the procedure
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
Time frame: During the procedure
Residual stenosis
The difference between the normal reference segment diameter and the minimum lumen diameter of the treated lesion after CAS (%)
Time frame: During the procedure
Focal neurological symptoms
Focal neurological symptoms ipsilateral to the treated carotid artery during the postprocedural observation period
Time frame: During the procedure and up to 1 day
Preoperative and postoperative ipsilateral carotid artery flow by doppler ultrasound
Peak-systolic and end-diastolic velocities (cm/sec)
Time frame: Preoperatively and 1 day after the procedure
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