About this trial
Endovascular thrombectomy (EVT) is the standard of care for acute ischemic stroke (AIS) caused by a large vessel occlusion.
Successful recanalization is one of the most important factors for a good patient outcome, especially when obtained within 30 minutes from groin puncture, and the procedural success-rate reaches above 90% at treating centers of excellence. There are however a portion of cases where recanalization is not achieved, which in some cases are attributed to difficult arterial anatomy affecting the ability to catheterize the precerebral target vessel.
In the latest angiography platforms, 3D reconstructions of the aortic, cervical and intracranial arteries from the preprocedural CT angiography can be fused with periprocedural 2D digital subtraction angiography and/or fluoroscopy images, so called 2D/3D Fusion imaging. The preparation steps can be done before patient arrival to the angiography suite and the image fusion can be done in less than a minute during patient preparation. Previous observational studies have shown that the use of fusion imaging during EVT procedures may decrease failed target vessel access and increase procedural success rate and first-pass recanalization rate, without prolonging the procedure.
The purpose of this study is to assess the use of fusion imaging in EVT procedures and its effect on target vessel access, recanalization success-rate and procedure times.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Eligible for an EVT procedure
Disqualifiers
Previous inclusion in this study
No access to a preoperative CTA
Trial design
Parallel
Treatments tested in this trial
Standard endovascular thrombectomy with Fusion
Procedure/SurgeryStandard endovacular procedure with the addition of Fusion imaging according to the intended use of the ARTIS Icono Biplane.
Standard EVT without Fusion
Procedure/SurgeryStandard endovacular procedure without the use of Fusion imaging on the ARTIS Icono Biplane.
Treatment groups
Trial outcomes
Primary outcomes
Successful recanalization
Defined as modified Treatment in Cerebral Infarction score (mTICI) 2b or better.
Secondary outcomes
Target vessel access
Successful catheterization of the precerebral target vessel
Excellent recanalization
Final recanlization grade defined as mTICI 2c or better
First pass recanalization
Successful recanalization on the first thrombectomy attempt.
Time from groin puncture to precerebral target vessel access
Defined as the time of the first angiography from the precerebral target vessel.
Other outcomes
Perioperative death
If the patient dies during the procedure or not.
Vessel perforation
Any intracranial vessel perforation with observed contrast extravasation on DSA.
Vessel dissection
Any iatrogenic arterial dissection.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Skane
Lead sponsor
Örebro Läns Landsting
Collaborator
Helsinki University Central Hospital
Collaborator
University of Turku
Collaborator
Lund University
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator