International journal of stroke : official journal of the International Stroke Society
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Randomized Controlled Trial Multicenter Study
Patent foramen ovale closure with GORE HELEX or CARDIOFORM Septal Occluder vs. antiplatelet therapy for reduction of recurrent stroke or new brain infarct in patients with prior cryptogenic stroke: Design of the randomized Gore REDUCE Clinical Study.
Rationale The utility of patent foramen ovale (PFO) closure for secondary prevention in patients with prior cryptogenic stroke is uncertain despite multiple randomized trials completed to date. Aims The Gore REDUCE Clinical Study (REDUCE) aims to establish superiority of patent foramen ovale closure in conjunction with antiplatelet therapy over antiplatelet therapy alone in reducing the risk of recurrent clinical ischemic stroke or new silent brain infarct in patients who have had a cryptogenic stroke. Methods and design This controlled, open-label trial randomized 664 subjects with cryptogenic stroke at 63 multinational sites in a 2:1 ratio to either antiplatelet therapy plus patent foramen ovale closure (with GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder) or antiplatelet therapy alone. ⋯ The trial should determine whether patent foramen ovale closure with the Gore septal occluders is safe and more effective than medical therapy alone for the prevention of recurrent clinical ischemic stroke or new silent brain infarct; the neuroimaging data will provide an opportunity to further support the proof of concept. The main results are anticipated in 2017. Registration Clinical trial registration-URL: http://clinicaltrials.gov/show/NCT00738894.
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Randomized Controlled Trial
Choice of ANesthesia for EndoVAScular Treatment of Acute Ischemic Stroke: Protocol for a randomized controlled (CANVAS) trial.
Background Observational studies indicate that the type of anesthesia, local or general, may be associated with the post-procedural neurological function in patients with acute ischemic stroke undergoing endovascular treatment. However, these results need further confirmation, and the causal relationship has not yet been established. Methods This is a randomized controlled equivalence trial. ⋯ The secondary endpoints are the peri-procedural mortality and morbidity. Discussion The study aims to determine the effects of anesthetic choice on neurological outcomes in patients with acute ischemic stroke undergoing intra-arterial recanalization. If the results are positive, the study will indicate that the type of anesthesia does not affect neurological outcome after endovascular treatment.