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Comparison of rescue intracranial stenting versus best medical treatment alone in acute refractory large vessel occlusion: study protocol for the PISTAR multicenter randomized trial
  1. Kévin Premat1,
  2. Agnès Dechartres2,
  3. Amandine Baptiste3,
  4. Alexis Guedon4,
  5. Mikael Mazighi5,
  6. Laurent Spelle6,7,
  7. Christian Denier8,
  8. Titien Tuilier9,
  9. Hassan Hosseini10,
  10. Bertrand Lapergue11,
  11. Federico Di Maria12,
  12. Nicolas Bricout13,
  13. Hilde Henon14,
  14. Benjamin Gory15,
  15. Sébastien Richard16,
  16. Cyril Chivot17,
  17. Audrey Courselle18,
  18. Stéphane Velasco19,
  19. Mathias Lamy20,
  20. Vincent Costalat21,
  21. Caroline Arquizan22,
  22. Gaultier Marnat23,
  23. Igor Sibon24,
  24. Stephanie Lenck1,
  25. Eimad Shotar1,
  26. Julien Allard1,
  27. Nader Sourour1,
  28. Vincent Degos25,
  29. Sonia Alamowitch26,
  30. Frédéric Clarençon1
  1. 1Department of Interventional Neuroradiology, Sorbonne Université, APHP, Pitié-Salpêtrière Hospital, Paris, France
  2. 2Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpital Pitié Salpêtrière, Département de Santé Publique, Paris, France
  3. 3Clinical Research Unit, Sorbonne Université, APHP, Hôpital Pitié-Salpêtrière, Paris, France
  4. 4Department of Neuroradiology, Lariboisière Hospital, Paris, France
  5. 5Department of Vascular Neurology, Lariboisière Hospital, Paris, France
  6. 6NEURI The Brain Vascular Center, Bicetre Hospital Interventional Neuroradiology, Le Kremlin-Bicetre, France
  7. 7Paris-Saclay University Faculty of Medicine, Le Kremlin-Bicetre, France
  8. 8Department of Neurology, Hopital Bicetre, Le Kremlin-Bicetre, France
  9. 9Department of Neuroradiology, Henri-Mondor Hospital, Creteil, France
  10. 10Department of Vascular Neurology, Henri-Mondor Hospital, Créteil, France
  11. 11Department of Vascular Neurology, Foch Hospital, Suresnes, France
  12. 12Department of Interventional and Diagnostic Neuroradiology, Foch Hospital, Suresnes, France
  13. 13Department of Neuroradiology, Lille University Hospital, Lille, France
  14. 14Department of Vascular Neurology, Lille University Hospital, Lille, France
  15. 15Department of Diagnostic and Therapeutic Neuroradiology, CHRU de Nancy, Nancy, France
  16. 16Neurology Stroke Unit, University Hospital Centre Nancy, Nancy, France
  17. 17Department of Radiology, Amiens University Hospital, Amiens, France
  18. 18Department of Neurology, Amiens University Hospital, Amiens, France
  19. 19Department of Radiology, Poitiers University Medical Center, Poitiers, France
  20. 20Department of Neurology, Poitiers University Medical Center, Poitiers, France
  21. 21Department of Neuroradiology, CHRU Gui de Chauliac, Montpellier, France
  22. 22Department of Neurology, CHRU Gui de Chauliac, Montpellier, France
  23. 23Department of Interventional and Diagnostic Neuroradiology, Bordeaux University Hospital, Bordeaux, France
  24. 24Department of Neurology, Bordeaux University Hospital, Bordeaux, France
  25. 25Department of Anesthesiology and NeuroIntensive Care, Sorbonne Université, APHP, Pitié-Salpêtrière Hospital, Paris, France
  26. 26Department of Neurology, Sorbonne Université, APHP, Pitié-Salpêtrière Hospital, Paris, France
  1. Correspondence to Dr Kévin Premat, Department of Interventional Neuroradiology, Hopitaux Universitaires Pitie Salpetriere-Charles Foix, Paris, 75013, France; kevin.premat{at}


Background Mechanical thrombectomy (MT) has become a standard treatment for acute ischemic strokes (AIS). However, MT failure occurs in approximately 10–30% of cases, leading to severe repercussions (with mortality rates up to 40% according to observational data). Among the available rescue techniques, rescue intracranial stenting (RIS) appears as a promising option.

Objective This trial is poised to demonstrate the superiority of RIS in addition to the best medical treatment (BMT) in comparison with BMT alone, in improving the functional outcomes at 3 months for patients experiencing an AIS due to a large vessel occlusion refractory to MT (rLVO).

Methods Permanent Intracranial STenting for Acute Refractory large vessel occlusions (PISTAR) is a multicenter prospective randomized open, blinded endpoint trial conducted across 11 French University hospitals. Adult patients (≥18 years) with an acute intracranial occlusion refractory to standard MT techniques will be randomized 1:1 during the procedure to receive either RIS+BMT (intervention arm) or BMT alone (control arm).

Results The primary outcome is the rate of good clinical outcome at 3 months defined as a modified Rankin Scale score ≤2 and evaluated by an independent assessor blinded to the randomization arm. Secondary outcomes include hemorrhagic complications, all adverse events, and death. The number of patients to be included is 346. Two interim analyses are planned with predefined stopping rules.

Conclusion The PISTAR trial is the first randomized controlled trial focusing on the benefit of RIS in rLVOs. If positive, this study will open new insights into the management of AIS.

Trial registration number NCT06071091.

  • Stroke
  • Thrombectomy
  • Stent
  • Atherosclerosis

Data availability statement

Data are available upon reasonable request.

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Data availability statement

Data are available upon reasonable request.

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  • Correction notice Since this article first published, the affiliation for the author Agnes Dechartres has been updated.

  • Contributors All participating authors have significantly contributed to the research. The corresponding author ensured that appropriate permissions were obtained; and acts as the guarantor of this article. The corresponding author accepts full responsibility for the content and conduct of the study, had access to the data, and made the decision to publish. KP designed, drafted, and revised the paper. He is the guarantor. AD and AB planned statistical analysis, designed the trial, and revised the paper. AG, MM, LS, CD, TT, HHo, BL, FDM, NB, HHe, BG, SR, CC, AC, SV, ML, VC, CA, GM, IS, SL, ES, JA, NS, VD, SA collected data and revised the paper. FC designed the trial, revised the paper, and provided structural overview of the project.

  • Funding This trial is funded by a national public grant: PHRC-IR (Programme Hospitalier de Recherche Clinique Interrégional); PHRC # APHP210091. Free devices (intracranial stent systems) are provided by one exclusive manufacturer (Stryker Neurovascular). This company holds no role in the conception of the study; nor will it participate in the data collection, analysis, interpretation of results, or decision to publish.

  • Competing interests NS reports a conflict of interest with Medtronic, Balt Extrusion, Microvention (consultant). FC reports a conflict of interest with Medtronic, Balt Extrusion (consultant), ClinSearch (core laboratory), Penumbra, Stryker (payment for reading), and Artedrone (board). The other authors report no conflicts of interest.

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

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.