Neuroform Atlas Stent System Study

NCT02340585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2023-03-24

Study results available
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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.

Conditions

  • Intracranial Aneurysm

Interventions

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.

Sponsors & Collaborators

  • Stryker Neurovascular

    lead INDUSTRY

Principal Investigators

  • Osama Zaidat, MD · Mercy Health - St. Vincent Medical Center

  • Brian Jankowitz, MD · Cooper University Health Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-18
Primary Completion
2021-12-13
Completion
2022-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02340585 on ClinicalTrials.gov