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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DynaCT Imaging in EVAR: Comparing Clinical Benefit of DynaCT to Multidetector CT as the Current Gold Standard.

NCT00264862

Abdominal Aortic Aneurysm

COMPLETED NA

Venous Distension in Patients With Aneurysmatic Arterial Disease

NCT02867501

Aortic Aneurysm, Abdominal Popliteal Artery Aneurysm Peripheral Arterial Occlusive Disease +3 more

COMPLETED

Ultra-low Dose Contrast for Endovascular Procedures

NCT06835127

Renal Impairment Limb Ischemia, Critical

ACTIVE_NOT_RECRUITING

Relation betwEen Abdominal Aorta and Carotid Artery Responses to SymPathetic stimulatiON uSing duplEx Ultrasound

NCT04035252

Abdominal Aortic Aneurysm

COMPLETED

Pre-emptive Abdominal Aortic Aneurysm Sac Embolization During EVAR

NCT05575570

Abdominal Aortic Aneurysm Without Rupture

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carotid Artery Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A: Reduced contrast media dose group

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 Type EXPERIMENTAL

Carotid artery stenting with reduced contrast media protocol

Intervention Type PROCEDURE

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.

Carotid Duplex Ultrasound

Intervention Type DIAGNOSTIC_TEST

Pre- and postinterventional assessment of the treated internal carotid artery.

Group B: Standard contrast media dose group

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 Type ACTIVE_COMPARATOR

Carotid artery stenting with standard contrast media protocol

Intervention Type PROCEDURE

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.

Carotid Duplex Ultrasound

Intervention Type DIAGNOSTIC_TEST

Pre- and postinterventional assessment of the treated internal carotid artery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Carotid 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.

Intervention Type PROCEDURE

Carotid 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.

Intervention Type PROCEDURE

Carotid Duplex Ultrasound

Pre- and postinterventional assessment of the treated internal carotid artery.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Arterial access Preinterventional selective carotid artery angiography Carotid artery stenting Postinterventional selective carotid artery angiography Arterial access Preinterventional selective carotid artery angiography Carotid artery stenting Postinterventional selective carotid artery angiography

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No