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

May 15, 2014 updated by: Stryker Neurovascular
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Groupe Hospitalier Pellegrin
      • Dijon, France, 21033
        • CHU Dijon-Hopital General
      • Limoges, France, 87042
        • CHU Limoges
      • Montpellier, France, 34059
        • Hopital Gui de Chauliac
      • Nantes, France, 44035
        • CHU Hôpital Guillaume et René Laënnec
      • Nice, France, 06000
        • Hôpital Saint-Roch
      • Paris, France, 75010
        • Hôpital Lariboisière
      • Paris, France, 75019
        • Fondation Rotschild
      • Reims, France, 51100
        • CHU Reims
      • Toulouse, France, 31059
        • CHU Toulouse
  • Germany
      • Augsburg, Germany, 86156
        • Klinikum Augsburg
      • Dresden, Germany, 1307
        • Universitätsklinikum Dresden
      • Düsseldorf, Germany, 40335
        • Universitätsklinikum Düsseldorf
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen
      • Essen, Germany, 45122
        • Universitätsklinikum Essen
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Hamburg, Germany, 22763
        • Asklepios Klinik Altona
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Kiel, Germany, 24105
        • UKSH Campus Kiel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

39 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Peri-procedural
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.
30 days
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.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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)
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stryker Neurovascular

Investigators

  • Principal Investigator: Emmanuel Houdart
  • Principal Investigator: Marius Hartmann

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 26, 2009

First Submitted That Met QC Criteria

June 26, 2009

First Posted (Estimate)

June 29, 2009

Study Record Updates

Last Update Posted (Estimate)

June 17, 2014

Last Update Submitted That Met QC Criteria

May 15, 2014

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRISS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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