An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis (IRISS)
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|ClinicalTrials.gov Identifier: NCT00929383|
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
|Condition or disease||Intervention/treatment|
|Intracranial Atherosclerosis||Device: Wingspan Stent System with Gateway PTA Balloon Catheter|
|Study Type :||Observational|
|Actual Enrollment :||82 participants|
|Official Title:||An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis|
|Study Start Date :||February 2009|
|Primary Completion Date :||March 2013|
|Study Completion Date :||March 2013|
Device: Wingspan Stent System with Gateway PTA Balloon Catheter
- Wingspan™ Stent System
- 3.5F Delivery Catheter (pre-loaded with Wingspan™ Stent)
- Gateway™ Over-The-Wire PTA Balloon Catheter
- Rotating Hemostatic Valve
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.
- Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion) [ Time Frame: Peri-procedural ]The number of Wingspan Stents successfully deployed across the target lesion.
- Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death) [ Time Frame: 30 days ]
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.
- Rate of Recurrent Ischemic Stroke in the Target Territory [ Time Frame: 12 Months ]The rate of recurrent ischemic stroke from 31 days to 12 months post procedure was 1.3% or 1 event per 77 patients analyzed.
- Cumulative Stroke Rate at 12 Months [ Time Frame: 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
- Rate of Restenosis [ Time Frame: 12 Months ]
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929383
|Groupe Hospitalier Pellegrin|
|Bordeaux, France, 33076|
|CHU Dijon-Hopital General|
|Dijon, France, 21033|
|Limoges, France, 87042|
|Höpital Gui de Chauliac|
|Montpellier, France, 34059|
|CHU Hôpital Guillaume et René Laënnec|
|Nantes, France, 44035|
|Nice, France, 06000|
|Paris, France, 75010|
|Paris, France, 75019|
|Reims, France, 51100|
|Toulouse, France, 31059|
|Augsburg, Germany, 86156|
|Dresden, Germany, 1307|
|Düsseldorf, Germany, 40335|
|Erlangen, Germany, 91054|
|Essen, Germany, 45122|
|Freiburg, Germany, 79106|
|Asklepios Klinik Altona|
|Hamburg, Germany, 22763|
|Heidelberg, Germany, 69120|
|UKSH Campus Kiel|
|Kiel, Germany, 24105|
|Principal Investigator:||Emmanuel Houdart|
|Principal Investigator:||Marius Hartmann|