1. First-line use of contact aspiration for thrombectomy versus a stent retriever for recanalization in acute cerebral infarction: The randomized ASTER study protocol
- Author
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Michel Piotin, Georges Rodesch, Arturo Consoli, Raphaël Blanc, Francis Turjman, Xavier Barreau, Mikael Mazighi, Hubert Desal, Bertrand Lapergue, Serge Bracard, Aster Trial Investigators, Vincent Costalat, Julien Labreuche, Benjamin Gory, Jérôme Berge, Sandrine Baffert, Alain Duhamel, Susanna Saleme, Hôpital Foch [Suresnes], Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Rothschild [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Bordeaux [Bordeaux], Département de Neuro-Radiologie [Bordeaux] (DNR - Bordeaux), CHU Limoges, Département de Neuroradiologie[Montpellier], Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Gui de Chauliac [CHU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université de Montpellier (UM), Université de Montpellier (UM), Département de neuroradiologie diagnostique et thérapeutique [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Imagerie Adaptative Diagnostique et Interventionnelle (IADI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital Guillaume-et-René-Laennec [Saint-Herblain], Hôpital Rothschild [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and Hôpital Gui de Chauliac [Montpellier]-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université Montpellier 1 (UM1)-Université de Montpellier (UM)
- Subjects
Adult ,Male ,medicine.medical_specialty ,Catheters ,[SDV]Life Sciences [q-bio] ,medicine.medical_treatment ,030218 nuclear medicine & medical imaging ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Clinical Protocols ,Randomized controlled trial ,law ,Modified Rankin Scale ,medicine ,Humans ,Single-Blind Method ,Thrombectomy ,Stent retriever ,Cerebral infarction ,business.industry ,Cerebral Infarction ,Thrombolysis ,Surgical Instruments ,medicine.disease ,3. Good health ,Surgery ,Stroke ,Clinical trial ,Mechanical thrombectomy ,Treatment Outcome ,Neurology ,Sample size determination ,Reperfusion ,Female ,business ,030217 neurology & neurosurgery - Abstract
Rationale Mechanical thrombectomy with a stent retriever is now the standard of care in anterior circulation ischemic stroke caused by large vessel occlusion. New techniques for mechanical thrombectomy, such as contact aspiration, appear promising to increase reperfusion status and improve clinical outcome. Aim We aim at ascertaining whether contact aspiration is more efficient than the stent retriever as a first-line endovascular procedure. Sample size estimates With a two-sided test (alpha = 5%, power = 90%) and an anticipated rate of spontaneous recanalization and catheterization failures of 15%, we estimate that a sample size of 380 patients will be necessary to detect an absolute difference of 15% in primary outcome (superiority design). Methods and design The ASTER trial is a prospective, randomized, multicenter, controlled, open-label, blinded end-point clinical trial. Patients admitted with suspected ischemic anterior circulation stroke secondary to large vessel occlusion, with onset of symptoms Study outcomes The primary outcome will be successful recanalization (modified Thrombolysis in Cerebral Infarction score 2b–3) at the end of the endovascular procedures. Secondary outcome will include successful recanalization after the assigned first-line treatment technique alone, procedural times, the need for a rescue technique, complications and modified Rankin Scale at three months. Discussion No previous head to head randomized trials have directly compared contact aspiration versus stent retriever reperfusion techniques. This prospective trial aims to provide further evidence of benefit of contact aspiration versus stent retriever techniques among patients with ischemic stroke.
- Published
- 2017
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