Clinical trial NCT00929383: An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis
Official title: An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Atherosclerosis
Keywords: Intracranial Atherosclerosis
Stenosis
ICAD
atherosclerotic lesions
stenting
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2009-06-29
Enrollment: 82
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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)

Primary outcomes:
measure: Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion)
timeFrame: Peri-procedural
measure: Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death)
timeFrame: 30 days
measure: Rate of Recurrent Ischemic Stroke in the Target Territory
timeFrame: 12 Months
Secondary outcomes:
measure: Cumulative Stroke Rate at 12 Months
timeFrame: 12 months
measure: Rate of Restenosis
timeFrame: 12 Months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Dijon
country: France
facility: CHU Dijon-Hopital General
city: Limoges
country: France
facility: CHU Limoges
city: Montpellier
country: France
facility: Höpital Gui de Chauliac
city: Nantes
country: France
facility: CHU Hôpital Guillaume et René Laënnec
city: Nice
country: France
facility: Hôpital Saint-Roch
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Fondation Rotschild
city: Reims
country: France
facility: CHU Reims
city: Toulouse
country: France
facility: CHU Toulouse
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Kiel
country: Germany
facility: UKSH Campus Kiel
Study officials:
name: Emmanuel Houdart
role: PRINCIPAL_INVESTIGATOR
name: Marius Hartmann
role: PRINCIPAL_INVESTIGATOR
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