Fusion Imaging in Endovascular Thrombectomy for Acute Ischemic Stroke

NCT06975696 | Recruiting

• 1 other identifier: 2024-08348-01
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 4

Brief 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

Keywords

Stroke; endovascular thrombectomy; fusion; interventional neuroradiology; procedure; mTICI

Outcome Measures

Primary Outcomes (1)

• Successful recanalization

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

  At the end of the EVT procedure

Secondary Outcomes (8)

• Target vessel access

  During the EVT procedure

• Excellent recanalization

  At the end of the procedure

• First pass recanalization

  At the end of the procedure

• Time from groin puncture to precerebral target vessel access

  During the procedure

• Time from groin puncture to first pass with stent-retriever and/or direct aspiration.

  During the procedure.

Other Outcomes (3)

• Perioperative death

  During the procedure.

• Vessel perforation

  During the procedure.

• Vessel dissection

  During the procedure.

Study Arms (2)

EVT without Fusion

ACTIVE COMPARATOR

Standard endovascular treatment

Procedure: Standard EVT without Fusion

EVT with Fusion

EXPERIMENTAL

Standard endovascular thrombectomy with Fusion

Procedure: Standard endovascular thrombectomy with Fusion

Interventions

Standard endovascular thrombectomy with Fusion PROCEDURE

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

EVT with Fusion

Standard EVT without Fusion PROCEDURE

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

EVT without Fusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Eligible for an EVT procedure

You may not qualify if:

• No access to a preoperative CTA

Sponsors & Collaborators

• Region Skane: lead
• Örebro Läns Landsting: collaborator
• Helsinki University Central Hospital: collaborator
• University of Turku: collaborator
• Lund University: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (4)

Helsinki University Central Hospital

Helsinki, Finland

NOT YET RECRUITING

Turku University Hospital

Turku, Finland

NOT YET RECRUITING

Skane University Hospital Lund

Lund, 22185, Sweden

RECRUITING

Örebro University Hospital

Örebro, 70185, Sweden

NOT YET RECRUITING

Related Publications (11)

• Fusion Imaging in Endovascular Thrombectomy for Acute Ischemic Stroke. Lovisa Landström, Emma Hall, Björn Hansen and Johan Wassélius. Stroke: Vascular and Interventional Neurology. Online ahead of print. doi: 10.1161/SVIN.124.001636

  RESULT

• Ribo M, Flores A, Rubiera M, Pagola J, Mendonca N, Rodriguez-Luna D, Pineiro S, Meler P, Alvarez-Sabin J, Molina CA. Difficult catheter access to the occluded vessel during endovascular treatment of acute ischemic stroke is associated with worse clinical outcome. J Neurointerv Surg. 2013 May;5 Suppl 1:i70-3. doi: 10.1136/neurintsurg-2012-010438. Epub 2012 Oct 31.

  PMID: 23117130 RESULT

• Snelling BM, Sur S, Shah SS, Chen S, Menaker SA, McCarthy DJ, Yavagal DR, Peterson EC, Starke RM. Unfavorable Vascular Anatomy Is Associated with Increased Revascularization Time and Worse Outcome in Anterior Circulation Thrombectomy. World Neurosurg. 2018 Dec;120:e976-e983. doi: 10.1016/j.wneu.2018.08.207. Epub 2018 Sep 6.

  PMID: 30196176 RESULT

• Penide J, Mirza M, McCarthy R, Fiehler J, Mordasini P, Delassus P, Morris L, Gilvarry M. Systematic Review on Endovascular Access to Intracranial Arteries for Mechanical Thrombectomy in Acute Ischemic Stroke. Clin Neuroradiol. 2022 Mar;32(1):5-12. doi: 10.1007/s00062-021-01100-7. Epub 2021 Oct 12.

  PMID: 34642788 RESULT

• Lajthia O, Almallouhi E, Ali H, Essibayi MA, Bass E, Neyens R, Anadani M, Chalhoub R, Kicielinski K, Lena J, Porto G, Sattur M, Spiotta AM, Kasab SA. Failed mechanical thrombectomy: prevalence, etiology, and predictors. J Neurosurg. 2023 Jan 20;139(3):714-720. doi: 10.3171/2022.12.JNS222152. Print 2023 Sep 1.

  PMID: 36670537 RESULT

• Wasselius J, Hall E, Ramgren B, Andersson T, Ullberg T. Procedural factors associated with successful recanalization in patients with acute ischemic stroke treated with endovascular thrombectomy-a nationwide register-based observational study. Interv Neuroradiol. 2024 Apr 22:15910199241248268. doi: 10.1177/15910199241248268. Online ahead of print.

  PMID: 38646674 RESULT

• Fischer U, Kaesmacher J, Strbian D, Eker O, Cognard C, Plattner PS, Butikofer L, Mordasini P, Deppeler S, Pereira VM, Albucher JF, Darcourt J, Bourcier R, Benoit G, Papagiannaki C, Ozkul-Wermester O, Sibolt G, Tiainen M, Gory B, Richard S, Liman J, Ernst MS, Boulanger M, Barbier C, Mechtouff L, Zhang L, Marnat G, Sibon I, Nikoubashman O, Reich A, Consoli A, Lapergue B, Ribo M, Tomasello A, Saleme S, Macian F, Moulin S, Pagano P, Saliou G, Carrera E, Janot K, Hernandez-Perez M, Pop R, Schiava LD, Luft AR, Piotin M, Gentric JC, Pikula A, Pfeilschifter W, Arnold M, Siddiqui AH, Froehler MT, Furlan AJ, Chapot R, Wiesmann M, Machi P, Diener HC, Kulcsar Z, Bonati LH, Bassetti CL, Mazighi M, Liebeskind DS, Saver JL, Gralla J; SWIFT DIRECT Collaborators. Thrombectomy alone versus intravenous alteplase plus thrombectomy in patients with stroke: an open-label, blinded-outcome, randomised non-inferiority trial. Lancet. 2022 Jul 9;400(10346):104-115. doi: 10.1016/S0140-6736(22)00537-2.

  PMID: 35810756 RESULT

• Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.

  PMID: 26898852 RESULT

• Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. 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. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.

  PMID: 31662037 RESULT

• Jang KM, Choi HH, Nam TK, Byun JS. Clinical outcomes of first-pass effect after mechanical thrombectomy for acute ischemic stroke: A systematic review and meta-analysis. Clin Neurol Neurosurg. 2021 Dec;211:107030. doi: 10.1016/j.clineuro.2021.107030. Epub 2021 Nov 11.

  PMID: 34823155 RESULT

• Alawieh A, Pierce AK, Vargas J, Turk AS, Turner RD, Chaudry MI, Spiotta AM. The golden 35 min of stroke intervention with ADAPT: effect of thrombectomy procedural time in acute ischemic stroke on outcome. J Neurointerv Surg. 2018 Mar;10(3):213-220. doi: 10.1136/neurintsurg-2017-013040. Epub 2017 May 2.

  PMID: 28465405 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Study Officials

• Ulrika Andersson, MSc

  Lund University

  STUDY DIRECTOR

• Johan Wasselius, MD, PhD

  Skåne University Hospital and Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Wasselius, MD, PhD

CONTACT

+46-46173082; johan.wasselius@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multinational, multicenter, prospective, randomized trial

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 16, 2025
• Study Start: March 2, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2); SE (2)