Direct transfer to angiosuite for patients with severe acute stroke treated with thrombectomy: the multicentre randomised controlled DIRECT ANGIO trial protocol. Issue 3 (15th March 2021)

• Record Type: Journal Article
• Authors: Riou-Comte, Nolwenn; Zhu, François; Cherifi, Aboubaker; Richard, Sébastien; Nace, Lionel; Audibert, Gérard; Achit, Hamza; Costalat, Vincent; Arquizan, Caroline; Beaufils, Olivier; Consoli, Arturo; Lapergue, Bertrand; Loeb, Thomas; Rouchaud, Aymeric; Macian, Francisco; Cailloce, Dominique; Biondi, Alessandra; Moulin, Thierry; Desmettre, Thibaut; Marnat, Gaultier; Sibon, Igor; Combes, Xavier; Lebedinsky, Ariel Pablo; Vuillemet, Francis; Kempf, Nicolas; Pierot, Laurent; Moulin, Solene; Lemmel, Philippe; Mazighi, Mikael; Blanc, Raphael; Sabben, Candice; Schluck, Eric; Bracard, Serge; Anxionnat, René; Guillemin, Francis; Hossu, Gabriela; Gory, Benjamin;
• Other Names: author non-byline.; Gory Benjamin author non-byline.; Costa Isabelle author non-byline.; Bracard Serge author non-byline.; Anxionnat René author non-byline.; Braun Marc author non-byline.; Derelle Anne-Laure author non-byline.; Tonnelet Romain author non-byline.; Liao Liang author non-byline.; Zhu François author non-byline.; Schmitt Emmanuelle author non-byline.; Planel Sophie author non-byline.; Richard Sébastien author non-byline.; Humbertjean Lisa author non-byline.; Mione Gioia author non-byline.; Lacour Jean-Christophe author non-byline.; Riou-Comte Nolwenn author non-byline.; Hossu Gabriela author non-byline.; Beaumont Marine author non-byline.; Bailang Mitchelle author non-byline.; Audibert Gérard author non-byline.; Reitter Marie author non-byline.; Masson Agnès author non-byline.; Alb Lionel author non-byline.; Tabarna Adriana author non-byline.; Voicu Marcela author non-byline.; Podar Iona author non-byline.; Brezeanu Madalina author non-byline.; Biondi Alessandra author non-byline.; Vitale Giovanni author non-byline.; Caterino Fortunato Di author non-byline.; Charbonnier Guillaume author non-byline.; Primikiris Panagiotis author non-byline.; Moulin Thierry author non-byline.; Medeiros Elisabeth de Bustos author non-byline.; Bouamra Benjamin author non-byline.; Bonnet Louise author non-byline.; Vuillier Fabrice author non-byline.; Desmettre Thibaut author non-byline.; Lebedinsky Pablo A author non-byline.; Musacchio Mariano author non-byline.; Bolognini Frederico author non-byline.; Vuillemet Francis author non-byline.; Kempf Nicolas author non-byline.; Cohen-Khallas Elie author non-byline.; Fickl Andreas author non-byline.; Schluck Eric author non-byline.; Goudot Mathilde author non-byline.; Courtois Sylvie author non-byline.; Mostoufizadehghalamfarsa Sohrab author non-byline.; Porta Alessandro La author non-byline.; Soize Sébastien author non-byline.; Moulin Solène author non-byline.; Pierot Laurent author non-byline.; Manceau Pierre-François author non-byline.; Sahnoun Maher author non-byline.; Gelmini Christophe author non-byline.; Caucheteux Nathalie author non-byline.; Hua Vi Tuan author non-byline.; Serre Isabelle author non-byline.; Hoang Mickaël author non-byline.; Pradeau Catherine author non-byline.; Marnat Gaultier author non-byline.; Gariel Florent author non-byline.; Barreau Xavier author non-byline.; Berge Jérôme author non-byline.; Veunac Louis author non-byline.; Menegon Patrice author non-byline.; Sibon Igor author non-byline.; Lucas Ludovic author non-byline.; Olindo Stéphane author non-byline.; Renou Pauline author non-byline.; Sagnier Sharmila author non-byline.; Poli Mathilde author non-byline.; Debruxelles Sabrina author non-byline.; Mene Jean-Marc author non-byline.; Sesay Musa author non-byline.; Costalat Vincent author non-byline.; Arquizan Caroline author non-byline.; Dargazanli Cyril author non-byline.; Gascou Grégory author non-byline.; Lefèvre Pierre-Henri author non-byline.; Derraz Imad author non-byline.; Riquelme Carlos author non-byline.; Gaillard Nicolas author non-byline.; Mourand Isabelle author non-byline.; Corti Lucas author non-byline.; Piotin Michel author non-byline.; Blanc Raphael author non-byline.; Redjem Hocine author non-byline.; Escalard Simon author non-byline.; Desilles Jean-Philippe author non-byline.; Ciccio Gabriele author non-byline.; Smajda Stanislas author non-byline.; Mazighi Mikael author non-byline.; Obadia Mikael author non-byline.; Sabben Candice author non-byline.; Corabianu Ovide author non-byline.; Broucker Thomas de author non-byline.; Smadja Didier author non-byline.; Alamowitch Sonia author non-byline.; Ille Olivier author non-byline.; Manchon Eric author non-byline.; Garcia Pierre-Yves author non-byline.; Taylor Guillaume author non-byline.; Maacha Malek Ben author non-byline.; Wang Adrien author non-byline.; Evrard Serge author non-byline.; Tchikviladze Maya author non-byline.; Ajili Nadia author non-byline.; Lapergue Bertrand author non-byline.; Weisenburger David author non-byline.; Gorza Lucas author non-byline.; Coskun Oguzhan author non-byline.; Consoli Arturo author non-byline.; Maria Federico Di author non-byline.; Rodesh Georges author non-byline.; Leguen Morgan author non-byline.; Gratieux Julie author non-byline.; Pico Fernando author non-byline.; Rakotoharinandrasana Haja author non-byline.; Tassan Philippe author non-byline.; Poll Roxanna author non-byline.; Marinier Sylvie author non-byline.; Rouchaud Aymerci author non-byline.; Saleme Suzana author non-byline.; Mounayer Charbel author non-byline.; Macian-Montoro Francisco author non-byline.; Cailloce Dominique author non-byline.;
• Is Part Of: BMJ open. Volume 11:Issue 3(2021)
• Publication Date: 2021-03-15
• Subjects: interventional radiology -- stroke medicine -- clinical trials; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-040522
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : 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 .