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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00929383
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Information provided by (Responsible Party):
Stryker Neurovascular

Brief 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.

Condition or disease Intervention/treatment
Intracranial Atherosclerosis Device: Wingspan Stent System with Gateway PTA Balloon Catheter

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.

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Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis
Study Start Date : February 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Intervention Details:
  • 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.

    Other Names:
    • Wingspan™ Stent System
    • 3.5F Delivery Catheter (pre-loaded with Wingspan™ Stent)
    • Gateway™ Over-The-Wire PTA Balloon Catheter
    • Rotating Hemostatic Valve

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures :
  1. 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

  2. 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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   41 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with symptomatic intracranial atherosclerotic stenosis. Patients will be included who are eligible for endovascular treatment and for which treatment with the Wingspan™ Stent system has been judged necessary by the treating physician.

Inclusion Criteria:

  • Symptomatic stenosis of one of those intracranial arteries: Internal carotid artery (ICA ), M1 segment of the MCA, V4 segment of vertebral artery, basilar artery
  • A Modified Rankin Score of ≤ 3
  • A target vessel diameter between 2mm and ≤ 4.5mm
  • Length of the target lesion of ≤ 14 mm
  • Patient older than 40 years old

Exclusion Criteria:

  • Patient previously stented at the target lesion
  • Intracranial stenosis related to disease such as: arterial dissection, Moya Moya disease, vasculitis, radiation induced vasculopathy or fibromuscular dysplasia
  • Complete occlusion of the artery on the imaging assessment
  • Contraindications to antithrombotic and/or anticoagulant therapies
  • Women who are pregnant or breast-feeding
  • Patient not likely to be available for follow-up
  • Patient protected by the law (safeguard of justice, supervision or trusteeship)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00929383

Show Show 19 study locations
Sponsors and Collaborators
Stryker Neurovascular
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Principal Investigator: Emmanuel Houdart
Principal Investigator: Marius Hartmann


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Responsible Party: Stryker Neurovascular Identifier: NCT00929383    
Other Study ID Numbers: IRISS
First Posted: June 29, 2009    Key Record Dates
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014
Last Verified: September 2012
Keywords provided by Stryker Neurovascular:
Intracranial Atherosclerosis
atherosclerotic lesions
Additional relevant MeSH terms:
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Intracranial Arteriosclerosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases