Carotid Artery Diseases
Conditions
Keywords
Radiocontrast media reduction, X-ray angiography, Digital Variance Angiography, Digital Subtraction Angiography, carotid artery stenting, Kinepict
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.
Interventions
DIAGNOSTIC_TESTCarotid Duplex Ultrasound
Pre- and postinterventional assessment of the treated internal carotid artery.
PROCEDURECarotid 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.
PROCEDURECarotid 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.
Sponsors
Semmelweis University
Bács-Kiskun County Teaching Hospital
Kinepict Health Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Residual stenosis | During the procedure | The difference between the normal reference segment diameter and the minimum lumen diameter of the treated lesion after CAS (%) |
| Total procedural dose area product | During the procedure | Indicator of a patient's irradiation dosage (microGy\*cm2 or Gy\*cm2) |
| 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) |
| 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 |
| 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) |
Countries
Hungary
Contacts
Primary ContactPéter Sótonyi, MD, PhD
Backup ContactPeter T Legeza, MD
Outcome results
None listed