Abstract 3118: Star: Solitaire Fr Thrombectomy For Acute Revascularisation, International Clinical Evaluation Of The Solitaire™ Fr Used In The Treatment Of Patients With Acute Ischemic Stroke
Objective: The aim of the study is to evaluate mechanical thrombectomy with the Solitaire FR when used according to hospitals’ stroke protocols (direct intra-arterial, bridging IV/IA and endovascular after failed or contraindicated IV lysis).
Design: Single arm, observational, multi-center, prospective study with consecutive inclusion.
Sample size: The target number of patients is 200 in 20 centers with a maximum of 30 patients per center.
Centers: 2 centers in Switzerland, 9 centers in Germany, 1 in Austria, 4 centers in Spain, 1 in Canada, 1 in Australia, 1 in Portugal, 1 in France.
Study population: Patients presenting with acute ischemic stroke in anterior circulation, aged 18-85 years. Baseline NIH stroke scale between 8 and 30. Pre-stroke mRS ≤2. Treatment initiated within 8 hours of symptom onset. Meet specific imaging criteria based on ASPECT score.
Interventions: Patients will be treated with the Solitaire FR Revascularization Device used as 1st intention device in routine practice.
Endpoints: Primary endpoint will be recanalization of the occluded vessel, core lab reviewed, using TICI score with TICI 2b and 3 defined as successful recanalization. Correspondent TIMI scores will be determined for comparison with other studies.
Safety endpoint: Adverse events related to the device or the procedure. All adverse events will be reviewed by an independent clinical event committee.
Secondary endpoints: Time to revascularization, NIHSS at 90 days, mRS at 90 days, incidence of symptomatic intracranial hemorrhage, immediate flow reperfusion.
Trial status: Enrollment is ongoing. There are currently 7 enrolling centers with a total of 37 patients.
Registers: ClinicalTrials.gov NCT01327989
- © 2012 by American Heart Association, Inc.