NCT00929383

An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 82 (actual)
• Sponsor: Stryker Neurovascular · Industry
• Sex: All
• Age: 41 Years
• Healthy volunteers: Not accepted

Summary

The IRISS study is designed to collect clinical and angiographic outcomes data when stenting intracranial atherosclerotic lesions using the Wingspan™ Stent System with Gateway™ PTA Balloon Catheter in routine clinical practice.

Detailed description

The Wingspan™ Stent System and Gateway™ PTA Balloon Catheter have CE mark and are commonly used in Europe. All the data collected in this registry will be from patients treated according to the physician's choice, per instructions for use, per approved indications and per local standard of care. The results from this registry will provide an understanding of the use and outcomes associated with the Wingspan™ Stent in a real world setting.

Conditions

• Intracranial Atherosclerosis

Interventions

Type	Name	Description
DEVICE	Wingspan Stent System with Gateway PTA Balloon Catheter	The Wingspan Stent System is used in conjunction with Gateway PTA Balloon Catheter to improve cerebral artery lumen diameter in patients with intracranial atherosclerotic disease. The Gateway Balloon Catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries prior to stenting the artery for the purpose of improving intracranial perfusion.

Timeline

• Start date: 2009-02-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-06-29
• Last updated: 2014-06-17
• Results posted: 2014-06-17

Locations

19 sites across 2 countries: France, Germany