N/A
Completed N=182
Neuroform Atlas Stent System Study
Source: ClinicalTrials.gov NCT02340585 ↗Enrolled (actual)
182
Serious AEs
30.2%
Results posted
Mar 2023
Primary outcomePrimary: Stroke or Death — 8; 5 Participants
Summary
The primary objective of this study is to demonstrate effectiveness and safety of the Neuroform Atlas Stent System for use with bare metal embolic coils.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stroke or Death |
8; 5 | — |
| PRIMARY Aneurysm Occlusion of the Treated Target Lesion on 12 Month Angiography |
135; 81 | — |
| SECONDARY The Percent of Subjects Experiencing One or More Serious Adverse Events (SAEs) Through 12 Months |
20; 19 | — |
Eligibility Criteria
Inclusion Criteria
- Subject is between 18 and 80 years of age
- Documented wide neck (neck ≥ 4 mm or a dome-to-neck ratio of 3.0 without oral anticoagulation therapy
- A known absolute contraindication to angiography
- Evidence of active cancer, terminal illness or any condition which, in the opinion of the treating physician, would/could prevent subject from completing the study (e.g., a high risk of embolic stroke, atrial fibrillation, co-morbidities, psychiatric disorders, substance abuse, major surgery ≤ 30 days pre-procedure, etc.)
- Known absolute contraindication to the use of required study medications or agents (e.g., heparin, aspirin, clopidogrel, and radiographic contrast agents, etc.)
- Female subject who is pregnant or intends to become pregnant during the study
- Moya-Moya disease, arteriovenous malformation(s), arteriovenous fistula(e), intracranial tumor(s), or intracranial hematoma(s) (unrelated to target aneurysm)
- Significant atherosclerotic stenosis, significant vessel tortuosity, vasospasm refractory to medication, unfavorable aneurysm morphology or vessel anatomy, or some other condition(s) that, in the opinion of the treating physician, would/could prevent or interfere with access to the target aneurysm and/or successful deployment of the Neuroform Atlas™ Stent
- Previous treatment (e.g., surgery, stenting) in the parent artery that, in the opinion of the treating physician, would/could prevent or interfere with successful use of the Neuroform Atlas™ Stent System and/or successful adjunctive deployment of embolic coils
- Previous stent-assisted coiling of the target aneurysm
Data sourced from ClinicalTrials.gov (NCT02340585). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.