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

Intracranial Atherosclerosis Clinical Trial

— IRISS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929383
• Other study ID #: IRISS
• Status: Completed
• Phase: N/A
• First received: June 26, 2009
• Last updated: May 15, 2014
• Start date: February 2009
• Est. completion date: March 2013

Study information

• Verified date: September 2012
• Source: Stryker Neurovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Haute Autorité de Santé Transparency CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 41 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis

Intervention

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.

Locations

Country	Name	City	State
France	Groupe Hospitalier Pellegrin	Bordeaux
France	CHU Dijon-Hopital General	Dijon
France	CHU Limoges	Limoges
France	Höpital Gui de Chauliac	Montpellier
France	CHU Hôpital Guillaume et René Laënnec	Nantes
France	Hôpital Saint-Roch	Nice
France	Fondation Rotschild	Paris
France	Hôpital Lariboisière	Paris
France	CHU Reims	Reims
France	CHU Toulouse	Toulouse
Germany	Klinikum Augsburg	Augsburg
Germany	Universitätsklinikum Dresden	Dresden
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Universitätsklinikum Essen	Essen
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Asklepios Klinik Altona	Hamburg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	UKSH Campus Kiel	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Neurovascular

Countries where clinical trial is conducted

France,  Germany, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Fiorella D, Woo HH. Emerging endovascular therapies for symptomatic intracranial atherosclerotic disease. Stroke. 2007 Aug;38(8):2391-6. Epub 2007 Jun 21. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1212/01.wnl.0000306308.08229.a3. Epub 2008 Jan 30. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful Wingspan™ Stent Implantation (Access to the Lesion With the Stent, Accurate Deployment of the Stent Across the Target Lesion)	The number of Wingspan Stents successfully deployed across the target lesion.	Peri-procedural	No
Primary	Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death)	Any stroke or neurological death at There was a 14.6% rate of cumulative morbidity and mortality at 30 days comprised of 12 events/82 patients.	30 days	Yes
Primary	Rate of Recurrent Ischemic Stroke in the Target Territory	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	Yes
Secondary	Cumulative Stroke Rate at 12 Months	The cumulative stroke rate at 12 months (any stroke or neurological death	12 months	Yes
Secondary	Rate of Restenosis	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	Yes