Fusion Imaging in Endovascular Thrombectomy for Acute Ischemic Stroke

ConditionStroke Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane

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 volunteers

Qualifiers

Age ≥18 years.

Eligible for an EVT procedure

Disqualifiers

Previous inclusion in this study

No access to a preoperative CTA

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard endovascular thrombectomy with Fusion

    Procedure/Surgery

    Standard endovacular procedure with the addition of Fusion imaging according to the intended use of the ARTIS Icono Biplane.

  • Standard EVT without Fusion

    Procedure/Surgery

    Standard endovacular procedure without the use of Fusion imaging on the ARTIS Icono Biplane.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: EVT without FusionActive comparator 1 intervention
Group B: EVT with FusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Successful recanalization

Defined as modified Treatment in Cerebral Infarction score (mTICI) 2b or better.

Time frame
At the end of the EVT procedure

Secondary outcomes

1

Target vessel access

Successful catheterization of the precerebral target vessel

Time frame
During the EVT procedure
2

Excellent recanalization

Final recanlization grade defined as mTICI 2c or better

Time frame
At the end of the procedure
3

First pass recanalization

Successful recanalization on the first thrombectomy attempt.

Time frame
At the end of the procedure
4

Time from groin puncture to precerebral target vessel access

Defined as the time of the first angiography from the precerebral target vessel.

Time frame
During the procedure

Other outcomes

1

Perioperative death

If the patient dies during the procedure or not.

Time frame
During the procedure.
2

Vessel perforation

Any intracranial vessel perforation with observed contrast extravasation on DSA.

Time frame
During the procedure.
3

Vessel dissection

Any iatrogenic arterial dissection.

Time frame
During the procedure.

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