E-071 Final Results of the Solitaire FR Thrombectomy for Acute Revascularisation (STAR) - Prospective, Multi-Centre, Controlled Clinical Trial in EU, Australia, and Canada
Bibliographic record
Abstract
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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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".