An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis (IRISS)
|Study Design:||Observational Model: Cohort; Time Perspective: Prospective|
Device: Wingspan Stent System with Gateway PTA Balloon Catheter
Patients eligible were diagnosed with symptomatic Intracranial Atheroslcerotic disease and scheduled to be treated with a Wingspan Stent in 6 centers in France and 9 centers in Germany.
The first patient was enrolled on 11 March 2009 and last patient on 30 April 2012.
|This was an open label registry (observational study). All patients scheduled for treatment with a Wingspan Stent meeting inclusion/exclusion criteria were eligible for participation.|
|Wingspan||Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site|
Participant Flow: Overall Study
Prospective, open label registry. All patients meeting inclusion/exclusion at the study centers were eligible for paritcipation.
As this was an observational registry, no statistical hypothesis was stated a priori.
|Patients Treated With a Wingspan Stent||Prospective, single arm, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site|
|Patients Treated With a Wingspan Stent|
Overall Participants Analyzed
Mean (Standard Deviation)
|1. Primary:||Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion) [ Time Frame: Peri-procedural ]|
|2. Primary:||Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death) [ Time Frame: 30 days ]|
|3. Primary:||Rate of Recurrent Ischemic Stroke in the Target Territory [ Time Frame: 12 Months ]|
|4. Secondary:||Cumulative Stroke Rate at 12 Months [ Time Frame: 12 months ]|
|5. Secondary:||Rate of Restenosis [ Time Frame: 12 Months ]|
Limitations and Caveats
|No text entered.|
|Principal Investigators are NOT employed by the organization sponsoring the study.|
|There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.|
Results Point of Contact:
Organization: Stryker Neurovascular
|Responsible Party:||Stryker Neurovascular|
|ClinicalTrials.gov Identifier:||NCT00929383 History of Changes|
|Other Study ID Numbers:||
|Study First Received:||June 26, 2009|
|Results First Received:||March 14, 2014|
|Last Updated:||May 15, 2014|