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NCT05720975
Efficacy and Safety Evaluation of the Thromboaspiration Catheter System iNstroke in Patients With Acute Ischemic Stroke
Conditions: Acute Ischemic Stroke
Sex: All
Ages: 18 Years – N/A
Enrollment: 95
Sponsor: iVascular S.L.U.
Location: Spain
Summary
First prospective, single-arm, single-centre study to evaluate the efficacy and safety of the iNstroke thromboaspiration catheter system (iNstroke) for stroke in patients with acute ischemic stroke.
Eligibility Criteria
Inclusion Criteria:Patients with acute ischaemic stroke over 18 years of age caused by large vessel occlusion and receiving neurointerventional treatment with the iNstroke aspiration catheter.Informed consent signed by the patient or their representative.Patients with an ASPECTS (Alberta Stroke Program Early CT Score) score ≥ 6 and occlusion of a large vessel (TICA, M1, and tandem with TICA or M1 occlusion, vertebral or basilar).In those patients with more than 8 hours of symptom onset or with stroke on awakening or unknown onset stroke, treatment should be individualised and there should be a penumbra area in CT perfusion.Baseline NIHSS obtained before procedure of ≥6 points.Exclusion Criteria:Patients under 18 years of age.Patients with an ASPECTS score <6.Baseline NIHSS obtained before procedure of ≤ 6 points.Severe comorbidity and/or shortened life expectancyERm >2.Severe allergy to contrast media.Pregnant women.Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissectionMedical history of plateletopenia (Platelets <100,000)
Source: ClinicalTrials.gov (NCT05720975). StuddyBuddy aggregates publicly available trial information.