Fusion Imaging in Endovascular Thrombectomy for Acute Ischemic Stroke

Summary

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.

Conditions

• Stroke Acute

Interventions

PROCEDURE

Standard endovascular thrombectomy with Fusion

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

PROCEDURE

Standard EVT without Fusion

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

Sponsors & Collaborators

• Örebro Läns Landsting

  collaborator OTHER_GOV

• Helsinki University Central Hospital

  collaborator OTHER

• University of Turku

  collaborator OTHER

• Lund University

  collaborator OTHER

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• Region Skane

  lead OTHER

Principal Investigators

• Ulrika Andersson, MSc · Lund University

• Johan Wasselius, MD, PhD · Skåne University Hospital and Lund University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-02

Primary Completion

2027-05-31

Completion

2027-05-31

Countries

• Finland
• Sweden

Study Locations