First-line use of contact aspiration for thrombectomy versus a stent retriever for recanalization in acute cerebral infarction: The randomized ASTER study protocolстатья из журнала
Аннотация: 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 <6 h, will be randomly assigned to contact aspiration or stent retriever in a 1:1 ratio; stratified by center and prior IV thrombolysis. If the assigned treatment technique is not successful after three attempts, another technique will be applied, at the operator's discretion. 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.
Год издания: 2017
Авторы: Bertrand Lapergue, Julien Labreuche, Raphaël Blanc, Xavier Barreau, Jérôme Berge, Arturo Consoli, Georges Rodesch, Susanna Saleme, Vincent Costalat, Serge Bracard, Hubert Desal, Alain Duhamel, Sandrine Baffert, Mikaël Mazighi, Benjamin Gory, Francis Turjman, Michel Piotin
Издательство: SAGE Publishing
Источник: International Journal of Stroke
Ключевые слова: Acute Ischemic Stroke Management, Cerebrovascular and Carotid Artery Diseases, Stroke Rehabilitation and Recovery
Другие ссылки: International Journal of Stroke (PDF)
International Journal of Stroke (HTML)
HAL (Le Centre pour la Communication Scientifique Directe) (HTML)
PubMed (HTML)
International Journal of Stroke (HTML)
HAL (Le Centre pour la Communication Scientifique Directe) (HTML)
PubMed (HTML)
Открытый доступ: bronze
Том: 13
Выпуск: 1
Страницы: 87–95