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

NCT00929383 | Completed Results DMC

• 1 other identifier: IRISS
• Study Type: observational
• Target: 82
• Locations: 2 countries
• Sites: 19

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.

Conditions

Intracranial Atherosclerosis

Keywords

Intracranial Atherosclerosis; Stenosis; ICAD; atherosclerotic lesions; stenting

Outcome Measures

Primary Outcomes (3)

• 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

• Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death)

  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

  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 Outcomes (2)

• Cumulative Stroke Rate at 12 Months

  12 months

• Rate of Restenosis

  12 Months

Interventions

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.

Also known as: Wingspan™ Stent System, 3.5F Delivery Catheter (pre-loaded with Wingspan™ Stent), Gateway™ Over-The-Wire PTA Balloon Catheter, Rotating Hemostatic Valve

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stryker Neurovascular: lead

Study Sites (19)

Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

Location

CHU Dijon-Hopital General

Dijon, 21033, France

Location

CHU Limoges

Limoges, 87042, France

Location

Höpital Gui de Chauliac

Montpellier, 34059, France

Location

CHU Hôpital Guillaume et René Laënnec

Nantes, 44035, France

Location

Hôpital Saint-Roch

Nice, 06000, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Fondation Rotschild

Paris, 75019, France

Location

CHU Reims

Reims, 51100, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

Klinikum Augsburg

Augsburg, 86156, Germany

Location

Universitätsklinikum Dresden

Dresden, 1307, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40335, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Asklepios Klinik Altona

Hamburg, 22763, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

UKSH Campus Kiel

Kiel, 24105, Germany

Location

Related Publications (14)

• 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. doi: 10.1161/01.str.26.1.14.

  PMID: 7839388 BACKGROUND

• EC/IC Bypass Study Group. Failure of extracranial-intracranial arterial bypass to reduce the risk of ischemic stroke. Results of an international randomized trial. N Engl J Med. 1985 Nov 7;313(19):1191-200. doi: 10.1056/NEJM198511073131904.

  PMID: 2865674 BACKGROUND

• 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. doi: 10.1056/NEJMoa043033.

  PMID: 15800226 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.105.578229. Epub 2006 Jan 23.

  PMID: 16432056 BACKGROUND

• 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. doi: 10.3171/jns.1999.91.3.0415.

  PMID: 10470816 BACKGROUND

• 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. doi: 10.1161/01.STR.0000206142.03677.c2. Epub 2006 Feb 23.

  PMID: 16497979 BACKGROUND

• SSYLVIA Study Investigators. Stenting of Symptomatic Atherosclerotic Lesions in the Vertebral or Intracranial Arteries (SSYLVIA): study results. Stroke. 2004 Jun;35(6):1388-92. doi: 10.1161/01.STR.0000128708.86762.d6. Epub 2004 Apr 22.

  PMID: 15105508 BACKGROUND

• 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.

  PMID: 17032860 BACKGROUND

• 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. doi: 10.1161/STROKEAHA.106.477711. Epub 2007 Mar 29.

  PMID: 17395864 BACKGROUND

• 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. doi: 10.1227/01.NEU.0000290914.24976.83.

  PMID: 17881980 BACKGROUND

• 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.

  PMID: 18235078 BACKGROUND

• Fiorella D, Woo HH. Emerging endovascular therapies for symptomatic intracranial atherosclerotic disease. Stroke. 2007 Aug;38(8):2391-6. doi: 10.1161/STROKEAHA.107.482752. Epub 2007 Jun 21. No abstract available.

  PMID: 17585085 BACKGROUND

• 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. doi: 10.1159/000068744. No abstract available.

  PMID: 12656117 BACKGROUND

• 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.

  PMID: 10782772 BACKGROUND

MeSH Terms

Conditions

Intracranial Arteriosclerosis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: David Hess, Manager Clinical Affairs
• Organization: Stryker Neurovascular

david.hess@stryker.com

1-510-413-2642

Study Officials

• Emmanuel Houdart

  PRINCIPAL INVESTIGATOR

• Marius Hartmann

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2009
• First Posted: June 29, 2009
• Study Start: February 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 17, 2014
• Results First Posted: June 17, 2014

Record last verified: 2012-09

Locations

DE (9); FR (10)