| Autor: |
Lapergue B; 1 Hôpital Foch, University Versailles Saint Quentin en Yvelynes; Department of Stroke Center, Diagnostic and Interventional Neuroradiology, Suresnes, France., Labreuche J; 2 Department of Biostatistics, University of Lille, Lille, France., Blanc R; 3 Department of Diagnostic and Interventional Neuroradiology, Fondation Rothschild, Paris, France., Barreau X; 4 Department of Diagnostic and Interventional Neuroradiology, CHU Pellegrin, Bordeaux, France., Berge J; 4 Department of Diagnostic and Interventional Neuroradiology, CHU Pellegrin, Bordeaux, France., Consoli A; 1 Hôpital Foch, University Versailles Saint Quentin en Yvelynes; Department of Stroke Center, Diagnostic and Interventional Neuroradiology, Suresnes, France., Rodesch G; 1 Hôpital Foch, University Versailles Saint Quentin en Yvelynes; Department of Stroke Center, Diagnostic and Interventional Neuroradiology, Suresnes, France., Saleme S; 5 Department of Diagnostic and Interventional Neuroradiology, CHU Dupuytren, Limoges, France., Costalat V; 6 Department of Diagnostic and Interventional Neuroradiology, CHU Hôpital Gui de Chaulac, Montpellier, France., Bracard S; 7 Department of Diagnostic and Interventional Neuroradiology, Hôpital Neurologique, Nancy, France., Desal H; 8 Department of Diagnostic and Interventional Neuroradiology, Hôpital Guillaume et René Laennec, Nantes, France., Duhamel A; 3 Department of Diagnostic and Interventional Neuroradiology, Fondation Rothschild, Paris, France., Baffert S; 3 Department of Diagnostic and Interventional Neuroradiology, Fondation Rothschild, Paris, France., Mazighi M; 3 Department of Diagnostic and Interventional Neuroradiology, Fondation Rothschild, Paris, France., Gory B; 9 Department of Diagnostic and Interventional Neuroradiology, Hospices Civils de Lyon, Bron, France., Turjman F; 5 Department of Diagnostic and Interventional Neuroradiology, CHU Dupuytren, Limoges, France., Piotin M; 3 Department of Diagnostic and Interventional Neuroradiology, Fondation Rothschild, Paris, France. |
| Abstrakt: |
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. |
