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N/A Completed N=182 Treatment

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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