Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06975696

Fusion Imaging in Endovascular Thrombectomy for Acute Ischemic Stroke

Led by Region Skane · Updated on 2026-03-04

300

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

R

Region Skane

Lead Sponsor

Ö

Örebro Läns Landsting

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of fusion imaging during endovascular thrombectomy (EVT) procedures for acute ischemic stroke caused by large vessel occlusion. This study aims to assess whether fusion imaging can improve target vessel access, increase recanalization success rates, and reduce procedure times compared to standard EVT. Fusion imaging involves combining 3D reconstructions from preprocedural CT angiography with live 2D angiography during the procedure. Participants will be randomly assigned to receive either standard EVT with fusion imaging or standard EVT without fusion imaging. Fusion imaging is performed using the ARTIS Icono Biplane system and includes steps such as importing CT angiography images, removing bone structures, and overlaying vascular landmarks onto live fluoroscopy. The fusion process is done quickly during patient preparation and does not add radiation or prolong the procedure. The study is multinational and multicenter, enrolling approximately 300 patients. During the study, researchers will collect data from national or local quality registries or a study database. They will monitor procedure success rates, vessel access, recanalization times, and other outcomes using imaging core lab adjudication. Safety is monitored, but fusion imaging does not add procedural risk or radiation exposure. The study lasts until three months after the last patient is included, and participant data is handled securely and anonymously.

CONDITIONS

Brief Title

Fusion Imaging in Endovascular Thrombectomy for Acute Ischemic Stroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Eligible for an endovascular thrombectomy (EVT) procedure
Not Eligible

You will not qualify if you...

  • Previous inclusion in this study
  • No access to a preoperative CT angiography (CTA) scan

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Procedure duration on the day of treatment

Participants undergo an endovascular thrombectomy procedure either with Fusion imaging or standard treatment without Fusion.

1 procedure visit (in-person)

Follow-up

Duration - Up to 3 months after the procedure

Participants are monitored after the procedure using local or national quality registries and medical records for safety and outcome assessment.

Data collected from medical records and registries; no additional visits required

Trial Site Locations

Total: 4 locations

1

Helsinki University Central Hospital

Helsinki, Finland

Not Yet Recruiting

2

Turku University Hospital

Turku, Finland

Not Yet Recruiting

3

Skane University Hospital Lund

Lund, Sweden, 22185

Actively Recruiting

4

Örebro University Hospital

Örebro, Sweden, 70185

Not Yet Recruiting

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Research Team

J

Johan Wasselius, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Difficult catheter access to the occluded vessel during endovascular treatment of acute ischemic stroke is associated with worse clinical outcome.

Marc Ribo, Alan Flores, Marta Rubiera...

https://pubmed.ncbi.nlm.nih.gov/23117130

Unfavorable Vascular Anatomy Is Associated with Increased Revascularization Time and Worse Outcome in Anterior Circulation Thrombectomy.

Brian M Snelling, Samir Sur, Sumedh S Shah...

https://pubmed.ncbi.nlm.nih.gov/30196176

Systematic Review on Endovascular Access to Intracranial Arteries for Mechanical Thrombectomy in Acute Ischemic Stroke.

Joaquin Penide, Mahmood Mirza, Ray McCarthy...

https://pubmed.ncbi.nlm.nih.gov/34642788

Procedural factors associated with successful recanalization in patients with acute ischemic stroke treated with endovascular thrombectomy-a nationwide register-based observational study.

Johan Wassélius, Emma Hall, Birgitta Ramgren...

https://pubmed.ncbi.nlm.nih.gov/38646674

Thrombectomy alone versus intravenous alteplase plus thrombectomy in patients with stroke: an open-label, blinded-outcome, randomised non-inferiority trial.

Urs Fischer, Johannes Kaesmacher, Daniel Strbian...

https://pubmed.ncbi.nlm.nih.gov/35810756

Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials.

Mayank Goyal, Bijoy K Menon, Wim H van Zwam...

https://pubmed.ncbi.nlm.nih.gov/26898852

Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association.

William J Powers, Alejandro A Rabinstein, Teri Ackerson...

https://pubmed.ncbi.nlm.nih.gov/31662037

Clinical outcomes of first-pass effect after mechanical thrombectomy for acute ischemic stroke: A systematic review and meta-analysis.

Kyoung Min Jang, Hyun Ho Choi, Taek Kyun Nam...

https://pubmed.ncbi.nlm.nih.gov/34823155