Novel Delivery System Significantly Improves Technical Success and Safety of the Endovascular Clip System (eCLIPs) While Maintaining Efficacy for the Treatment of Wide-Necked Bifurcation Aneurysms: A Prospective, Multisite Registry
Bibliographic record
Abstract
BACKGROUND AND OBJECTIVES: The endovascular clip systems (eCLIPs) implant bridges the neck of wide neck bifurcation aneurysms. This study presents safety and efficacy of eCLIPs cases of the first generation, eCLIPs bifurcation remodeling system (eBRS), and the current generation, eCLIPs electrolytic bifurcation system (eB). METHODS: A prospective registry collected: patient age, sex, aneurysm details, safety end points, and occlusion scores. All patients were reported for safety events. A subset of 74% with eBRS implants and 99% with eB implants formed a group for efficacy. RESULTS: The mean age was 57 years, and 70% were female. The Registry describes 280 patients: 101 in eBRS group and 179 in eB, with aneurysms at bifurcation locations. Implantation success was 81% and 92% for eBRS and eB, respectively ( P = .007). The follow-up period averaged 38 months for eBRS and 12 months for eB cases. The all-cause death rate was 3.2% (7% for eBRS and 1.1% for eB, P = .007), and neurological death rate was 2.3% (5% for eBRS and 0.5% for eB, P = .014). The rate of stroke was 1.8%, 2.0% for eBRS and 1.7% for eB ( P = NS). Rate of repeat procedure was 4.6% (8.9% for eBRS and 2.2% for eB, P = .01). For 57 eBRS patients at average 38 months postprocedure, 77% had modified Raymond-Roy Occlusion Classification (mRROC) scores of 1, 19% had mRROC 2, and satisfactory result (1 + 2) of 96%. For 144 eB patients at average 12 months postprocedure, 81% had mRROC 1, 15% mRROC 2, and satisfactory result (1 + 2) of 96%. CONCLUSION: The eCLIPs implant provides durable aneurysm occlusion with a favorable safety profile. The current eB delivery system resulted in improved procedural and safety results over the archived eBRS. The eCLIPs platform offers an alternative treatment strategy for wide neck bifurcation aneurysms.
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 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) | 0.001 | 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 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".