BMJ Open (Mar 2021)

Direct transfer to angiosuite for patients with severe acute stroke treated with thrombectomy: the multicentre randomised controlled DIRECT ANGIO trial protocol

  • ,
  • Sebastien Soize,
  • Isabelle Serre,
  • Pierre-François Manceau,
  • Laurent Pierot,
  • Marine Beaumont,
  • Thierry Moulin,
  • Francis Guillemin,
  • Serge Bracard,
  • Mikael Mazighi,
  • Raphaël Blanc,
  • Michel Piotin,
  • Bertrand Lapergue,
  • Hocine Redjem,
  • Gabriele Ciccio,
  • Stanislas Smajda,
  • Arturo Consoli,
  • Oguzhan Coskun,
  • Federico Di Maria,
  • Adrien Wang,
  • Maya Tchikviladze,
  • Serge Evrard,
  • Benjamin Gory,
  • Charbel Mounayer,
  • Vincent Costalat,
  • Grégory Gascou,
  • Cyril Dargazanli,
  • Romain Tonnelet,
  • René Anxionnat,
  • Jérome Berge,
  • Xavier Barreau,
  • Alessandra Biondi,
  • Louis Veunac,
  • François Zhu,
  • Emmanuelle Schmitt,
  • Gioia Mione,
  • Lisa Humbertjean,
  • Jean-Christophe Lacour,
  • Sébastien Richard,
  • Aymeric Rouchaud,
  • Anne-Laure Derelle,
  • Isabelle Mourand,
  • Nicolas Gaillard,
  • Caroline Arquizan,
  • Fernando Pico,
  • Guillaume Charbonnier,
  • Candice Sabben,
  • Simon Escalard,
  • Suzana Saleme,
  • Gaultier Marnat,
  • Jean-Philippe Desilles,
  • Imad Derraz,
  • Mariano Musacchio,
  • Igor Sibon,
  • Malek Ben Maacha,
  • Pierre-Henri Lefevre,
  • Carlos Riquelme,
  • Gabriela Hossu,
  • Aboubaker Cherifi,
  • Sonia Alamowitch,
  • Nolwenn Riou-Comte,
  • Solene Moulin,
  • Morgan Leguen,
  • Olivier Ille,
  • Giovanni Vitale,
  • Lucas Corti,
  • Gérard Audibert,
  • Florent Gariel,
  • Liang Liao,
  • Ovide Corabianu,
  • Thomas de Broucker,
  • Didier Smadja,
  • Eric Manchon,
  • Pierre-Yves Garcia,
  • Guillaume Taylor,
  • David Weisenburger,
  • Lucas Gorza,
  • Georges Rodesh,
  • Julie Gratieux,
  • Haja Rakotoharinandrasana,
  • Philippe Tassan,
  • Roxanna Poll,
  • Sylvie Marinier,
  • Patrice Menegon,
  • Ludovic Lucas,
  • Stéphane Olindo,
  • Pauline Renou,
  • Sharmila Sagnier,
  • Mathilde Poli,
  • Sabrina Debruxelles,
  • Marc Braun,
  • Sophie Planel,
  • Lionel Nace,
  • Hamza Achit,
  • Olivier Beaufils,
  • Thomas Loeb,
  • Francisco Macian,
  • Dominique Cailloce,
  • Thibaut Desmettre,
  • Xavier Combes,
  • Ariel Pablo Lebedinsky,
  • Francis Vuillemet,
  • Nicolas Kempf,
  • Philippe Lemmel,
  • Eric Schluck,
  • Isabelle Costa,
  • Mitchelle Bailang,
  • Marie Reitter,
  • Agnès Masson,
  • Lionel Alb,
  • Adriana Tabarna,
  • Marcela Voicu,
  • Iona Podar,
  • Madalina Brezeanu,
  • Fortunato Di Caterino,
  • Panagiotis Primikiris,
  • Elisabeth de Bustos Medeiros,
  • Benjamin Bouamra,
  • Louise Bonnet,
  • Fabrice Vuillier,
  • Pablo A Lebedinsky,
  • Frederico Bolognini,
  • Elie Cohen-Khallas,
  • Andreas Fickl,
  • Mathilde Goudot,
  • Sylvie Courtois,
  • Sohrab Mostoufizadehghalamfarsa,
  • Alessandro La Porta,
  • Maher Sahnoun,
  • Christophe Gelmini,
  • Nathalie Caucheteux,
  • Vi Tuan Hua,
  • Mickaël Hoang,
  • Catherine Pradeau,
  • Jean-Marc Mene,
  • Musa Sesay,
  • Mikael Obadia,
  • Nadia Ajili,
  • Aymerci Rouchaud,
  • Francisco Macian-Montoro

DOI
https://doi.org/10.1136/bmjopen-2020-040522
Journal volume & issue
Vol. 11, no. 3

Abstract

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Introduction Mechanical thrombectomy (MT) increases functional independence in patients with acute ischaemic stroke with anterior circulation large vessel occlusion (LVO), and the probability to achieve functional independence decreases by 20% for each 1-hour delay to reperfusion. Therefore, we aim to investigate whether direct angiosuite transfer (DAT) is superior to standard imaging/emergency department-based management in achieving 90-day functional independence in patients presenting with an acute severe neurological deficit likely due to LVO and requiring emergent treatment with MT.Methods and analysis DIRECT ANGIO (Effect of DIRECT transfer to ANGIOsuite on functional outcome in patient with severe acute stroke treated with thrombectomy: the randomised DIRECT ANGIO Trial) trial is an investigator-initiated, multicentre, prospective, randomised, open-label, blinded endpoint (PROBE) study. Eligibility requires a patient ≤75 years, pre-stroke modified Rankin Scale (mRS) 0–2, presenting an acute severe neurological deficit and admitted within 5 hours of symptoms onset in an endovascular-capable centre. A total of 208 patients are randomly allocated in a 1:1 ratio to DAT or standard management. The primary outcome is the rate of patients achieving a functional independence, assessed as mRS 0–2 at 90 days. Secondary endpoints include patients presenting confirmed LVO, patients eligible to intravenous thrombolysis alone, patients with intracerebral haemorrhage and stroke-mimics, intrahospital time metrics, early neurological improvement (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0–1 at 24 hours) and mRS overall distribution at 90 days and 12 months. Safety outcomes are death and intracerebral haemorrhage transformation. Medico-economics analyses include health-related quality of life and cost utility assessment.Ethics and dissemination The DIRECT ANGIO trial was approved by the ethics committee of Ile de France 1. Study began in April 2020. Results will be published in an international peer-reviewed medical journal.Trial registration number NCT03969511.