Neqstent coil-assisted flow diverter (NQS) for the treatment of bifurcation aneurysms: the coil-assisted flow diversion safety and performance study (CAFI)
Bibliographic record
Abstract
BackgroundThe Neqstent coil-assisted flow diverter (NQS) is a neck bridging device to facilitate coil occlusion of intracranial aneurysms. CAFI is a prospective, single-arm, multicenter study on the safety and performance of the NQS adjunctive therapy device together with platinum coils for treatment of unruptured intracranial aneurysms. METHODS: Thirty-eight patients were enrolled. Primary endpoints were occlusion at 6 months for efficacy, and any major stroke or non-accidental death up to 30 days or major disabling stroke within 6 months for safety. Secondary endpoints were re-treatment rate, procedure time, and procedure/device-related adverse events. Procedural and follow-up imaging was reviewed by an independent core laboratory. Adverse events were reviewed and adjudicated by a clinical events committee. RESULTS: The NQS was successfully implanted in 36/38 aneurysms, 2/38 in the intention-to-treat group did not receive a NQS and were excluded from follow-up after 30 days. In the per protocol group (PP), 33/36 patients were available for angiographic follow-up. Device related adverse events were recorded in 4/38 (10.5%) patients, one hemorrhagic and three thromboembolic. In the PP group, immediate post-treatment adequate occlusion (RR1 and RR2) was seen in 9/36 (25%) and progressed to 28/36 (77.8%) at 6 months. Complete occlusion (RR1) was achieved in 29/36 (80.6%) at the last available angiogram (3/36 were post procedure). The mean procedure time was 129 min (50-300 min, median 120 min). CONCLUSION: The NQS in conjunction with coils appears to be effective in the treatment of intracranial wide-neck bifurcation aneurysms, but its safety remains to be proved in larger series. TRIAL REGISTRATION NUMBER: NCT04187573.
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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 | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 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".