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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT00929383
First received: June 26, 2009
Last updated: May 15, 2014
Last verified: September 2012
Results First Received: March 14, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Intracranial Atherosclerosis
Intervention: Device: Wingspan Stent System with Gateway PTA Balloon Catheter

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

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.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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
    Wingspan  
STARTED     82  
COMPLETED     67  
NOT COMPLETED     15  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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.


Reporting Groups
  Description
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

Baseline Measures
    Patients Treated With a Wingspan Stent  
Number of Participants  
[units: participants]
  82  
Age  
[units: years]
Mean ± Standard Deviation
  64.23  ± 10.78  
Gender  
[units: participants]
 
Female     22  
Male     60  



  Outcome Measures
  Show All Outcome Measures

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
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:  
Name/Title: David Hess, Manager Clinical Affairs
Organization: Stryker Neurovascular
phone: 1-510-413-2642
e-mail: david.hess@stryker.com


Publications:


Responsible Party: Stryker Neurovascular
ClinicalTrials.gov Identifier: NCT00929383     History of Changes
Other Study ID Numbers: IRISS
Study First Received: June 26, 2009
Results First Received: March 14, 2014
Last Updated: May 15, 2014
Health Authority: France: Haute Autorité de Santé Transparency Commission
Germany: Federal Institute for Drugs and Medical Devices