Skip to main content
OpenTrials
Completed

NCT Number: NCT00929383

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intracranial Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Constriction, Pathologic Intracranial Arterial Diseases Intracranial Arteriosclerosis Nervous System Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

41 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Pellegrin, Bordeaux, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Wingspan Stent System with Gateway PTA Balloon Catheter

Device

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Stryker Neurovascular

Industry

Registry information

Acronym: IRISS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 29, 2009
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.