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
  Purpose

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 Intervention
Intracranial Atherosclerosis
Device: Wingspan Stent System with Gateway PTA Balloon Catheter

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis

Resource links provided by NLM:


Further study details as provided by Stryker Neurovascular:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)



Enrollment: 82
Study Start Date: February 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929383

Locations
France
Groupe Hospitalier Pellegrin
Bordeaux, France, 33076
CHU Dijon-Hopital General
Dijon, France, 21033
CHU Limoges
Limoges, France, 87042
Höpital Gui de Chauliac
Montpellier, France, 34059
CHU Hôpital Guillaume et René Laënnec
Nantes, France, 44035
Hôpital Saint-Roch
Nice, France, 06000
Fondation Rotschild
Paris, France, 75019
Hôpital Lariboisière
Paris, France, 75010
CHU Reims
Reims, France, 51100
CHU Toulouse
Toulouse, France, 31059
Germany
Klinikum Augsburg
Augsburg, Germany, 86156
Universitätsklinikum Dresden
Dresden, Germany, 1307
Universitätsklinikum Düsseldorf
Düsseldorf, Germany, 40335
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Universitätsklinikum Essen
Essen, Germany, 45122
Universitätsklinikum Freiburg
Freiburg, Germany, 79106
Asklepios Klinik Altona
Hamburg, Germany, 22763
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
UKSH Campus Kiel
Kiel, Germany, 24105
Sponsors and Collaborators
Stryker Neurovascular
Investigators
Principal Investigator: Emmanuel Houdart
Principal Investigator: Marius Hartmann
  More Information

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

Keywords provided by Stryker Neurovascular:
Intracranial Atherosclerosis
Stenosis
ICAD
atherosclerotic lesions
stenting

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Intracranial Arteriosclerosis
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014