New Devices Designed to Improve the Long-Term Results of Endovascular Treatment of Intracranial Aneurysms
Bibliographic record
Abstract
SUMMARY: Endovascular coiling can improve the outcome of patients with ruptured intracranial aneurysms, but angiographic recurrences are frequent compared to surgical clipping. New coils or devices have been introduced to improve long-term results of endovascular treatment but none have been the object of a valid clinical trial. We have proposed a multicentric randomized double-blind study comparing radioactive and standard coil occlusion of aneurysms. The purpose of this article is to review issues that are specific to the design of clinical trials to assess embolic agents that could improve the long-term efficacy of endovascular treatment of intracranial aneurysms. The proposed trial is a randomized, multi-center, prospective, controlled trial comparing the new generation coils to standard platinum coils. Blinding, if at all possible, is preferable to minimize bias, at least for follow-up angiographic studies that should cover a period of 18 months. All patients with an intracranial aneurysm eligible for endovascular treatment would be proposed to participate. The study would enrol approximately 500 patients equally divided between the two groups, recruited within two years, to demonstrate a decrease in the recurrence rate, the primary outcome measure, from 20% to 10%. Secondary outcome measures should assure that complications, initial clinical and angiographic results remain unchanged. Independent data safety and monitoring committees are crucial to the credibility of trials and to ensure scientific rigor and objectivity. The scientific demonstration of an improved long-term efficacy, without significant compromise regarding safety, is mandatory before considering the widespread use of a new embolic device for the endovascular treatment of aneurysms.
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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 | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| 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".