NCT02340585

Neuroform Atlas Stent System Study

Safety and Effectiveness of the Treatment of Wide Neck, Intracranial, Saccular Aneurysms With the Next Generation Neuroform Stent System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: Stryker Neurovascular · Industry
• Sex: All
• Age: 18 Years – 80 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 with bare metal embolic coils.

Detailed description

The study is a prospective, multicenter, open-label, single arm trial designed to demonstrate the potential treatment of wide neck, intracranial, saccular aneurysms with the Next Generation Neuroform Stent System with any approved embolic coils currently on the market. The study will evaluate 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 months. Subjects with documented wide neck, intracranial, saccular aneurysms arising from a parent artery may potentially benefit from stent assisted coiling, provided they meet the other eligibility criteria. Data collected through the 12-month follow-up visit are intended to support Premarket Approval (PMA) application to the Food and Drug Administration (FDA). Long-term follow-up data collected through 3 years postoperative are intended to support post-approval study (PAS) requirements.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	Next Generation Neuroform Stent System	The Next Generation Neuroform Stent System is pre-loaded on a stent delivery wire and protected by a transfer sheath. An accessory pouch containing an optional stabilizer may be attached to the proximal end of the stent delivery wire to facilitate handling and stabilization.

Timeline

• Start date: 2015-06-18
• Primary completion: 2021-12-13
• Completion: 2022-09-30
• First posted: 2015-01-16
• Last updated: 2023-03-24
• Results posted: 2023-03-24

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated device study