Background and objective Acute ischemic stroke is a potentially devastating condition and leading cause of morbidity and mortality, affecting an estimated 800 000 people per year in the USA. The natural history of untreated or unrevascularized large vessel occlusions in acute stroke patients results in mortality rates approaching 30%, with only 25% achieving good neurologic outcomes at 90 days. Recently, data have demonstrated that early endovascular recanalization of large vessel occlusions results in better outcomes than medical therapy alone. However, the majority of patients in these studies were treated with a stent retriever based approach. The purpose of COMPASS is to evaluate whether patients treated with a direct aspiration first pass (ADAPT) approach have non-inferior functional outcomes to those treated with a stent retriever as the firstline (SRFL) approach.
Materials and methods All patients who meet the inclusion and exclusion criteria and consent to participate will be enrolled at participating centers. Treatment will be randomly assigned by a central web based system in a 1:1 manner to treatment with either ADAPT or SRFL thrombectomy. Statistical methodology is prespecified with details available in the statistical analysis plan.
Results The trial recently completed enrollment, and data collection/verification is ongoing. The final results will be made available on completion of enrollment and follow-up.
Conclusions This paper details the design of the COMPASS trial, a randomized, blinded adjudicator, concurrent, controlled trial of patients treated with either ADAPT or SRFL approaches in order to evaluate whether ADAPT results in non-inferior functional outcome.
Trial registration number NCT02466893, Results.
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Contributors Each author listed should receive authorship credit based on the material contribution to this article, their revision of this article, and their final approval of this article for submission to this journal. Alyssa Pierce assisted with the editing and revision of this manuscript.
Funding This research is supported by Penumbra Inc.
Competing interests AST: Codman, consulting, research grants;Penumbra, consulting, research grants; Microvention, consulting, researchgrants; Blockade, stock, consulting; Pulsar Vascular, stock, consulting,research grants; Medtronic, consulting, research grants; and Siemens, consulting.Investor: Cerebrotech, Endostream, Apama, The Stroke Project, Serenity, 3RiversMedical, and Synchron. Consultant: Cerebrotech, Endostream, The Stroke Project,Serenity, 3Rivers Medical, and Vastrax. JM: Investor: Rebound Medical, Viseon,Cerebrotech, Endostream, Apama, The Stroke Project, Comet Medical, Serenity,3Rivers Medical, and Synchron. Consultant: Rebound Medical, Viseon,Cerebrotech, Endostream, The Stroke Project, Serenity, 3Rivers Medical, and Synchron.AHS: Financial interests: StimSox, Valor Medical , Neuro Technology Investors,Cardinal, Medina Medical Systems, Buffalo Technology Partners Inc, and InternationalMedical Distribution Partners. Consultant: Codman, Medtronic, GuidePoint GlobalConsulting, Penumbra, Stryker, MicroVention, WL Gore and Associates, 3RiversMedical, Corindus, Amnis Therapeutics, CereVasc, Pulsar Vascular, The StrokeProject, Cerebrotech Medical Systems, Rapid Medical, Lazarus (acquired byMedtronic), Medina Medical (acquired by Medtronic), Reverse Medical (acquiredby Medtronic), Covidien (acquired by Medtronic), Neuravi, Silk Road Medical, andRebound Medical. PI/National Steering Committees: Penumbra, 3D Separator Trial,Covidien (now Medtronic), SWIFT PRIME and SWIFT DIRECT trials, MicroVention,FRED Trial, MicroVention, CONFIDENCE Study, LARGE Trial, POSITIVE Trial,Penumbra, COMPASS Trial Penumbra, and INVEST Trial. Board member: IntersocietalAccreditation Committee.
Ethics approval The study was approved by the institutional review board of the Medical University of South Carolina.
Provenance and peer review Not commissioned; externally peer reviewed.