Proxiaml Temporary Occlusion using Balloon Guide Catheter for Mechanical Thrombectomy (PROTECT-MT): Study protocol for a multicenter randomized trial
Bibliographic record
Abstract
Abstract Background and Rationale Uncertainty exists over balloon guide catheter(BGC) usage for Mechanical Thrombectomy(MT) in patients with acute ischemic stroke acute ischemic stroke due to anterior circulation large vessel occlusion. Objective To determine the effectiveness of balloon guide catheter(BGC) as compared to conventional guide catheter on functional outcome in patients with acute ischemic stroke and treated with MT. Design Proximal TEmporary oCclusion using balloon guide caTheter for Mechanical Thrombectomy (PROTECT-MT) is an investigator-initiated, multicenter, prospective, open label trial with blinded outcome assessment (PROBE design) assessing the effectiveness and safety of BGC in acute ischemic stroke. An estimated 1074 patients meet the inclusion criteria would be randomized (1:1) to receive either MT with BGC(intervention) or MT with conventional guide catheter(control). The primary outcome is an ordinal shift analysis of scores on the modified Rankin scale (mRS) at 90 days. Progress Recruitment started on February 7, 2023. At a meeting of the independent Data and Safety Monitoring Board in November 2023 to review primary outcome data available for 169 patients, they recommended suspension of recruitment due to safety concerns, which was implemented by the Trial Steering Committee (TSC) with 329 randomized patients. The TSC stopped recruitment due to the safety concerns persisted on further review of the data on April 18, 2024. Discussion PROTECT-MT is the largest RCT assessing the effectiveness of BGC versus conventional guide catheter on functional outcome in large vessel occlusion patients treated with MT, it will provide further randomized evidence on the role of BGC in AIS patients treated with MT.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.060 | 0.055 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.010 | 0.005 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.005 | 0.004 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.007 | 0.008 |
| Insufficient payload (model declined to judge) | 0.056 | 0.014 |
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 source (direct Gemma or distilled Codex), 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".