An International Registry of the Wingspan™ Stent System for the Treatment of Intracranial Atherosclerotic Stenosis - Full Text View

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:

MedlinePlus related topics: Atherosclerosis

U.S. FDA Resources

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 ]
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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	February 2009
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

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:

Sacco RL, Kargman DE, Gu Q, Zamanillo MC. Race-ethnicity and determinants of intracranial atherosclerotic cerebral infarction. The Northern Manhattan Stroke Study. Stroke. 1995 Jan;26(1):14-20.

[No authors listed] Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke. Results of an international randomized trial. The EC/IC Bypass Study Group. N Engl J Med. 1985 Nov 7;313(19):1191-200.

Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16.

Kasner SE, Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Benesch CG, Sila CA, Jovin TG, Romano JG, Cloft HJ; Warfarin Aspirin Symptomatic Intracranial Disease Trial Investigators. Predictors of ischemic stroke in the territory of a symptomatic intracranial arterial stenosis. Circulation. 2006 Jan 31;113(4):555-63. Epub 2006 Jan 23.

Connors JJ 3rd, Wojak JC. Percutaneous transluminal angioplasty for intracranial atherosclerotic lesions: evolution of technique and short-term results. J Neurosurg. 1999 Sep;91(3):415-23.

Marks MP, Wojak JC, Al-Ali F, Jayaraman M, Marcellus ML, Connors JJ, Do HM. Angioplasty for symptomatic intracranial stenosis: clinical outcome. Stroke. 2006 Apr;37(4):1016-20. Epub 2006 Feb 23.

SSYLVIA Study Investigators. Stenting of Symptomatic Atherosclerotic Lesions in the Vertebral or Intracranial Arteries (SSYLVIA): study results. Stroke. 2004 Jun;35(6):1388-92. Epub 2004 Apr 22.

Wojak JC, Dunlap DC, Hargrave KR, DeAlvare LA, Culbertson HS, Connors JJ 3rd. Intracranial angioplasty and stenting: long-term results from a single center. AJNR Am J Neuroradiol. 2006 Oct;27(9):1882-92.

Bose A, Hartmann M, Henkes H, Liu HM, Teng MM, Szikora I, Berlis A, Reul J, Yu SC, Forsting M, Lui M, Lim W, Sit SP. A novel, self-expanding, nitinol stent in medically refractory intracranial atherosclerotic stenoses: the Wingspan study. Stroke. 2007 May;38(5):1531-7. Epub 2007 Mar 29.

Levy EI, Turk AS, Albuquerque FC, Niemann DB, Aagaard-Kienitz B, Pride L, Purdy P, Welch B, Woo H, Rasmussen PA, Hopkins LN, Masaryk TJ, McDougall CG, Fiorella DJ. Wingspan in-stent restenosis and thrombosis: incidence, clinical presentation, and management. Neurosurgery. 2007 Sep;61(3):644-50; discussion 650-1.

Zaidat OO, Klucznik R, Alexander MJ, Chaloupka J, Lutsep H, Barnwell S, Mawad M, Lane B, Lynn MJ, Chimowitz M; NIH Multi-center Wingspan Intracranial Stent Registry Study Group. The NIH registry on use of the Wingspan stent for symptomatic 70-99% intracranial arterial stenosis. Neurology. 2008 Apr 22;70(17):1518-24. Epub 2008 Jan 30.

Fiorella D, Woo HH. Emerging endovascular therapies for symptomatic intracranial atherosclerotic disease. Stroke. 2007 Aug;38(8):2391-6. Epub 2007 Jun 21. Review. No abstract available.

Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) Trial Investigators. Design, progress and challenges of a double-blind trial of warfarin versus aspirin for symptomatic intracranial arterial stenosis. Neuroepidemiology. 2003 Mar-Apr;22(2):106-17. No abstract available.

Samuels OB, Joseph GJ, Lynn MJ, Smith HA, Chimowitz MI. A standardized method for measuring intracranial arterial stenosis. AJNR Am J Neuroradiol. 2000 Apr;21(4):643-6.

Responsible Party:	Stryker Neurovascular
ClinicalTrials.gov Identifier:	NCT00929383 History of Changes
Other Study ID Numbers:	IRISS
Study First Received:	June 26, 2009
Last Updated:	September 14, 2012
Health Authority:	France: Haute Autorité de Santé Transparency Commission France: French Data Protection Autority Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Stryker Neurovascular:

Intracranial Atherosclerosis
Stenosis
ICAD
atherosclerotic lesions
stenting

Additional relevant MeSH terms:

Atherosclerosis
Constriction, Pathologic
Intracranial Arteriosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Intracranial Arterial Diseases

Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013

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