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.
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.
Study Type
OBSERVATIONAL
Enrollment
82
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.
Groupe Hospitalier Pellegrin
Bordeaux, France
CHU Dijon-Hopital General
Dijon, France
Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion)
The number of Wingspan Stents successfully deployed across the target lesion.
Time frame: Peri-procedural
Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death)
Any stroke or neurological death at \</= 30 days will be included in the cumulative morbidity and mortality rate. There was a 14.6% rate of cumulative morbidity and mortality at 30 days comprised of 12 events/82 patients.
Time frame: 30 days
Rate of Recurrent Ischemic Stroke in the Target Territory
The rate of recurrent ischemic stroke from 31 days to 12 months post procedure was 1.3% or 1 event per 77 patients analyzed.
Time frame: 12 Months
Cumulative Stroke Rate at 12 Months
The cumulative stroke rate at 12 months (any stroke or neurological death \</= 30 days or any ischemic stroke in territory \>/= 31 days is 15.9% or 13 events per 82 patients
Time frame: 12 months
Rate of Restenosis
The rate of restenosis at 12 months was defined as the degree of residual stenosis greater than 50% as determined by the study sites using the WASID method. There was a 10.4% rate of restenosis \>50% or 8 patients out of 77 analyzed. The differences in this analysis population N=77 vs. ITT N= 82 populations results from exclusion of N=4 patients with no stent implanted and N=1 patient who died prior to any follow up measures of restenosis. The WASID method is a standardized protocol for measuring intracranial arterial stenosis. \[1-(Dstenosis/Dnormal)\] x100=% stenosis (where D=vessel diameter)
Time frame: 12 Months
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CHU Limoges
Limoges, France
Höpital Gui de Chauliac
Montpellier, France
CHU Hôpital Guillaume et René Laënnec
Nantes, France
Hôpital Saint-Roch
Nice, France
Hôpital Lariboisière
Paris, France
Fondation Rotschild
Paris, France
CHU Reims
Reims, France
CHU Toulouse
Toulouse, France
...and 9 more locations