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Original research
Combined use of contact aspiration and the stent retriever technique versus stent retriever alone for recanalization in acute cerebral infarction: the randomized ASTER 2 study protocol
  1. Bertrand Lapergue1,2,
  2. Julien Labreuche3,
  3. Raphaël Blanc4,
  4. Gaultier Marnat5,
  5. Arturo Consoli6,
  6. Georges Rodesch7,
  7. Suzanna Saleme8,
  8. Vincent Costalat9,10,
  9. Serge Bracard11,
  10. Hubert Desal12,
  11. Alain Duhamel13,
  12. Mikael Mazighi14,
  13. Laurent Spelle15,
  14. Emmanuel Houdart16,
  15. Eimad Shotar17,
  16. Malek Ben Maacha18,
  17. Delphine Lopez19,
  18. Jean-Christophe Ferre20,
  19. Claire Prevot21,
  20. Benjamin Gory22,
  21. Michel Piotin23
  1. 1 Stroke Center Neurology Division, Hôpital Foch, Suresnes, France
  2. 2 Department of Stroke Center and Diagnostic and Interventional Neuroradiology, University of Versailles and Saint Quentin en Yvelines Foch Hospital, Surenes, France
  3. 3 Department of Biostatistics, University of Lille, CHU Lille, Lille, France
  4. 4 Fondation Ophtalmologique Adolphe de Rothschild, Paris, France
  5. 5 Interventional and Diagnostic Neuroradiology, Bordeaux University Hospital, Bordeaux, France
  6. 6 Interventional Neuroradiologie, Hôpital Foch, Suresnes, France
  7. 7 Department of Diagnostic and Interventional Neuroradiology, Hôpital Foch, Suresnes, France
  8. 8 University Hospital of Limoges, Limoges, France
  9. 9 Neuroradiology, CHRU Gui de Chauliac, Montpellier, France
  10. 10 Neuroradiology Department, University Hospital Güi-de-Chauliac, Centre Hospitalier Universitaire de Montpellier, Montpellier, France
  11. 11 Department of Diagnostic and Therapeutic Neuroradiology, CHRU Nancy, Hôpital Central Nancy, Nancy, France
  12. 12 Neuroradiology, University Hospital of Nantes, Nantes, France
  13. 13 Biostatistics, University of Lille, Lille, France
  14. 14 Department of Interventional Neuroradiology, Fondation Ophtalmologique Adolphe de Rothschild, Paris, France
  15. 15 Department of Diagnostic and Therapeutic Neuroradiology, Hôpitaux Universitaires Paris-Sud, Hôpital du Kremlin-Bicetre, Le Kremlin-Bicetre, France
  16. 16 Department of Interventional Neuroradiology, Hôpital Lariboisière, Paris, France
  17. 17 Department of Neuroradiology, Pitié-Salpêtrière Hospital, APHP, Paris, France
  18. 18 Biostatistics, Fondation Rothschild Hospital, Paris, France
  19. 19 University of Versailles and Saint Quentin en Yvelines, Foch Hospital, Suresnes, France
  20. 20 Radiology Department, University Hospital University Rennes Inria CNRS INSERM, Rennes F30533, France
  21. 21 Clinical Research Department, University of Versailles and Saint Quentin en Yvelines, Foch Hospital, Suresnes, France
  22. 22 Department of Diagnostic and Interventional Neuroradiology, CHRU Nancy, Nancy, France
  23. 23 Department of Interventional Neuroradiology, Fondation Rothschild Hospital, Paris, France
  1. Correspondence to Dr Bertrand Lapergue, Stroke Center Neurology Division, Hopital Foch, Suresnes 92140, France; b.lapergue{at}hopital-foch.org

Abstract

Rationale Mechanical thrombectomy (MT) using a stent retriever (SR) device is currently the recommended treatment in ischemic stroke due to anterior circulation large vessel occlusion. Combining contact aspiration (CA) with SR is a promising new treatment, although it was not found to be superior to SR alone as first-line treatment for achieving successful reperfusion.

Aim To determine whether endovascular treatment combining first-line use of CA and SR is more efficient than SR alone.

Methods The ASTER 2 clinical trial is a prospective, randomized, multicenter, open-label trial with a blinded endpoint. We included patients admitted with suspected anterior circulation ischemic stroke secondary to large vessel occlusion <8 hours from symptom onset. They were randomly allocated in a 1:1 ratio to one of two treatment groups (combined CA and SR or SR alone). In the case of failure of the assigned technique after three attempts, other adjunctive techniques were applied.

Study outcome The primary outcome is the rate of successful/complete reperfusion (modified Thrombolysis In Cerebral Infarction (mTICI) score 2c/3) after the entire endovascular procedure. Secondary outcomes include reperfusion rates after the assigned first-line intervention alone and at the end of the procedure, procedural times, change in NIH Stroke Scale score at 24 hours, intracerebral hemorrhage at 24 hours, procedure-related serious adverse events, the modified Rankin Scale score, and all-cause mortality at 90 days and 1 year. The cost effectiveness of the two procedures will also be analyzed.

Discussion This is the first head-to-head randomized trial to directly compare the efficacy of the combined use of CA and SR versus SR alone. This prospective trial aims to demonstrate the synergistic effects of CA and SR devices in first-line endovascular treatment.

  • acute ischemic stroke
  • mechanical thrombectomy
  • contact aspiration
  • stent retriever
  • randomized controlled trial
  • anterior circulation
  • France
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Footnotes

  • Contributors Principal investigators of the ASTER 2 trial: BL, RB, GM, AC, GR, SS, VC, SB, HD, MM, LS, EH, ES, BG, MP. Statistical analysis plan: JL, AD. Planning and conducting the study: MBM, DL, CP.

  • Funding This work was supported by an unrestricted research grant provided by Penumbra, Stryker and Microvention, and a grant from the French Ministry of Health (PHRC 17-0292).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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