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

June 26, 2009
May 15, 2014
February 2009
March 2013   (final data collection date for primary outcome measure)
  • Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion) [ Time Frame: Peri-procedural ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    The rate of recurrent ischemic stroke from 31 days to 12 months post procedure was 1.3% or 1 event per 77 patients analyzed.
  • Successful Wingspan™ Stent implantation (access to the lesion with the stent, accurate deployment of the stent across the target lesion) [ Time Frame: Peri-procedural ] [ Designated as safety issue: No ]
  • Cumulative Morbidity and Mortality rate (ischemic event, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage or death) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Rate of recurrent ischemic stroke in the target territory [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00929383 on ClinicalTrials.gov Archive Site
  • Cumulative Stroke Rate at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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)

  • Cumulative stroke rate at 12 months (and 3 and 6 months if available) [ Time Frame: 3, 6 and12 Months ] [ Designated as safety issue: Yes ]
  • Rate of restenosis [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis
An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Intracranial Atherosclerosis
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
March 2013
March 2013   (final data collection date for primary outcome measure)

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)
Both
41 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany
 
NCT00929383
IRISS
Yes
Stryker Neurovascular
Stryker Neurovascular
Not Provided
Principal Investigator: Emmanuel Houdart
Principal Investigator: Marius Hartmann
Stryker Neurovascular
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP