NCT02783339

Neuroform Atlas Stent for Intracranial Aneurysm Treatment

Evaluation of Safety and Performance of the Neuroform AtlasTM Stent System for Intracranial Aneurysm Treatment - Post Market Clinical Follow-up

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 105 (estimated)
• Sponsor: Stryker Neurovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate effectiveness and safety of the NeuroForm Atlas stent system for use in patients requiring stent assisted intracranial aneurysm treatment.

Detailed description

The study is a prospective, multicenter, open-label, single arm post market follow-up registry designed to demonstrate the potential treatment of intracranial, saccular aneurysms with the Next Generation Neuroform Stent System. The study will evaluate the permanent morbidity and mortality rate within the 12 to 16 months following the procedure. The study will evaluate as well the percent occlusion of the treated target lesion on angiography in the absence of retreatment, or parent artery stenosis at the target location at 12 to 16 months. Subjects with documented saccular aneurysms arising from a parent artery may potentially benefit from stent assisted coiling, provided they meet the other eligibility criteria.

Conditions

• Intracranial Aneurysm

Timeline

• Start date: 2016-09-01
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2016-05-26
• Last updated: 2020-08-28

Locations

11 sites across 3 countries: France, Germany, Slovakia