title: REVASCAT: a randomized trial of revascularization with SOLITAIRE FR device vs. best medical therapy in the treatment of acute stroke due to anterior circulation large vessel occlusion presenting within eight-hours of symptom onset.
abstract: REVASCAT is a prospective, multicenter, randomized trial seeking to establish whether subjects meeting following main inclusion criteria: age 18-80, baseline National Institutes of Health Stroke Scale ≥6, evidence of intracranial internal carotid artery or proximal (M1 segment) middle cerebral artery occlusion, Alberta Stroke Program Early Computed Tomography score of >7 on non-contrast CT or >6 on diffusion-weighted magnetic resonance imaging , ineligible for or with persistent occlusion after intravenous alteplase and procedure start within 8 hours from symptom onset, have higher rates of favorable outcome when treated with the Solitaire FR embolectomy device compared to standard medical therapy alone The primary end-point, based on intention-to-treat criteria is the distribution of modified Rankin Scale scores at 90 days. Projected sample size is 690 patients. Estimated common odds ratio is 1●615. Randomization is performed under a minimization process using age, baseline NIHSS, therapeutic window, occlusion location and investigational center. The study follows a sequential analysis (triangular model) with the first approach to test efficacy at 174 patients and subsequent analyses (if necessary) at 346, 518, and 690 subjects. Secondary end-points are infarct volume evaluated on CT at 24 h, dramatic early favorable response, defined as NIHSS of 0-2 or NIHSS improvement ≥8 points at 24 h and successful recanalization in the Solitaire arm according to the thrombolysis in cerebral infarction (TICI) classification defined as TICI 2b or 3. Safety variables are mortality at 90 days, symptomatic intracranial haemorrhage rates at 24 hours and procedure related complications.
authors.affiliation: Stroke Unit, Hospital Vall d'Hebron, Barcelona, Spain.
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Molina
authors.affiliation: Stroke Unit, Hospital Clinic Barcelona, Barcelona, Spain.
authors.forename: Angel
authors.initials: A
authors.lastname: Chamorro
authors.affiliation: Department of Neuroradiology, Hospital Vall d'Hebron, Barcelona, Spain.
authors.forename: Àlex
authors.initials: À
authors.lastname: Rovira
authors.affiliation: Department of Neuroradiology, Hospital de Bellvitge, Barcelona, Spain.
authors.forename: Angeles
authors.initials: A
authors.lastname: de Miquel
authors.affiliation: Department of Neurology, Hospital Josep Trueta, Girona, Spain.
authors.forename: Joaquin
authors.initials: J
authors.lastname: Serena
authors.affiliation: Department of Neuroradiology, Hospital Clinic Barcelona, Barcelona, Spain.
authors.forename: Luis San
authors.initials: LS
authors.lastname: Roman
authors.affiliation: Department of Neurological Surgery, UPMC, Pittsburgh, Pennsylvania, USA.
authors.forename: Tudor G
authors.initials: TG
authors.lastname: Jovin
authors.affiliation: Department of Neurology, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain.
authors.forename: Antoni
authors.initials: A
authors.lastname: Davalos
authors.affiliation: Universitat politecnica de catalunya, Barcelona, Spain.
authors.forename: Erik
authors.initials: E
authors.lastname: Cobo
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002340:Carotid Artery Diseases / Q000473:pathology / Q000601:surgery; D002343:Carotid Artery, Internal / Q000473:pathology; D038524:Diffusion Magnetic Resonance Imaging; D017128:Embolectomy / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D020244:Infarction, Middle Cerebral Artery / Q000473:pathology / Q000601:surgery; D020765:Intracranial Arterial Diseases / Q000473:pathology / Q000601:surgery; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D016037:Single-Blind Method; D020521:Stroke / Q000473:pathology / Q000601:surgery*; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D055815:Young Adult
keywords: acute stroke therapy; clinical trial; reperfusion; t-PA; therapy; treatment