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NCT05685043
BELgian CT-perFUSion Study to Select Acute Stroke Patients for Thrombectomy
Conditions: Stroke, Stroke, Acute, Stroke, Ischemic
Sex: All
Ages: 18 Years – 90 Years
Phase: NA
Enrollment: 518
Sponsor: University Hospital, Ghent
Summary
The goal of this clinical trial is to test whether perfusion CT can be used as a selection tool in stroke patients with a major anterior circulation occlusion, to exclude patients from thrombectomy because of a predicted non-beneficial outcome, when treated within 6 hours of symptom onset.Researchers will compare the experimental group, where mechanical thrombectomy is only performed when prespecified perfusion CT criteria are fulfilled, with the standard of care treatment group, where all patients will receive mechanical thrombectomy, to see if functional independence at 90 days is non-inferior.
Eligibility Criteria
Inclusion Criteria:Major vessel occlusion of the anterior cerebral circulation (internal carotid artery tip, middle cerebral artery or both) on CTARandomised within 6h of symptom onsetPerfusion CT scanASPECTS ≥ 5Age ≥18 years and ≤90 yearsSubjects capable of giving informed consent, or if appropriate, subjects having an acceptable individual capable of giving consent on the subject's behalf (e.g.
parent or guardian of a child under 16 years of age) within 3 days after treatment.Exclusion Criteria:Occlusion of a peripheral arterial segment (M3), anterior cerebral artery or posterior circulationEvidence of intracranial hemorrhage on initial CT scanBad functional condition before stroke (mRS >2)
Source: ClinicalTrials.gov (NCT05685043). StuddyBuddy aggregates publicly available trial information.