Solitaire FR is the first in the new generation of mechanical thrombectomy devices based on a stent retriever technology for the treatment of acute ischaemic stroke. The Solitaire FR Thrombectomy for Acute Revascularisation (STAR) study is the largest controlled, prospective, multi-centre study on the use of a stentriever only (Solitaire FR) for acute ischaemic stroke.
Methods Patients undergoing mechanical thrombectomy for acute ischaemic stroke in the anterior circulation were enrolled in 14 clinical sites in Europe, Canada and Australia. STAR is the first single arm, observational, controlled, multi-centre, prospective study using TICI 2b for revascularisation success. The aim of the study was to evaluate mechanical thrombectomy with the Solitaire FR when used as first intention device for the respective indications for mechanical thrombectomy. Patients were treated with the Solitaire FR Revascularisation Device in routine practice according to the ‘Instructions for Use’ (Balloon guiding catheter use and maximum number of 3 passes per vessel) to reach final result. The primary endpoint was revascularisation (TICI 2b) of the occluded vessel. The secondary endpoints were the clinical outcome mRS at 90 days, and time to revascularisation. The safety endpoints were the serious adverse events (SAEs) related to the device or the procedure. Patients were enrolled consecutively and there was an independent core-lab imaging review as well as a clinical events committee.
Results 202 patients were enrolled in the study with first enrolment in October 2010 and final enrolment in May 2012. The median age of the population was 72 years old and 60.4% of female patients. The median NIHSS was 17. Final patient follow-up occurred in September 2012 and the data has been completely independently monitored and core lab reviewed.
Conclusions In patients with acute ischaemic stroke, treatment with the Solitaire FR device indicated a high level of success in revascularising vessels in the proximal circulation. In real-world practice using established protocols, the STAR results indicate a new paradigm for improving patient outcomes. (ClinicalTrials.gov number NCT01327989).
Disclosures A. Bonafe: 2; C; covidien.
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