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Intracranial AtherosclerosisIRISSNCT00929383

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

An observational study of Intracranial Atherosclerosis, run by Stryker Neurovascular at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 41 years and older
Conditions the study is for
Intracranial Atherosclerosis
What is being tested?
Wingspan Stent System with Gateway PTA Balloon Catheter
Type of treatment
Medical device
How many people
82 participants
Where
19 sitesin 2 countries
Study dates
Feb 2009to Mar 2013
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 41 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

France10 sites

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33076

  • CHU Dijon-Hopital General

    Dijon, 21033

  • CHU Limoges

    Limoges, 87042

  • Höpital Gui de Chauliac

    Montpellier, 34059

  • CHU Hôpital Guillaume et René Laënnec

    Nantes, 44035

  • Hôpital Saint-Roch

    Nice, 06000

  • Hôpital Lariboisière

    Paris, 75010

  • Fondation Rotschild

    Paris, 75019

  • CHU Reims

    Reims, 51100

  • CHU Toulouse

    Toulouse, 31059

Other trials in France

Germany9 sites

  • Klinikum Augsburg

    Augsburg, 86156

  • Universitätsklinikum Dresden

    Dresden, 1307

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40335

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsklinikum Essen

    Essen, 45122

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Asklepios Klinik Altona

    Hamburg, 22763

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • UKSH Campus Kiel

    Kiel, 24105

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Wingspan Stent System with Gateway PTA Balloon Catheter
Keywords
Intracranial Atherosclerosis, Stenosis, ICAD, atherosclerotic lesions, stenting
Medical subject headings
Intracranial Arteriosclerosis, Constriction, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wingspan Stent System with Gateway PTA Balloon CatheterDevice

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

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Peri-procedural

  2. 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.

    Measured: 30 days

  3. 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.

    Measured: 12 Months

Secondary outcomes (2)

  1. Cumulative Stroke Rate at 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

    Measured: 12 months

  2. 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)

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00929383
Sponsor's protocol ID
IRISS
Acronym
IRISS
Status last verified
Sep 2012
First submitted
26 Jun 2009
Last updated
17 Jun 2014
Data monitoring committee
Yes

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. doi: 10.1161/01.str.26.1.14.

    PubMed 7839388

  • 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.

    PubMed 2865674

  • 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.

    PubMed 15800226

  • 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.

    PubMed 16432056

  • 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.

    PubMed 10470816

  • 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.

    PubMed 16497979

  • 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.

    PubMed 15105508

  • 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.

    PubMed 17032860

  • 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.

    PubMed 17395864

  • 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.

    PubMed 17881980

  • 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.

    PubMed 18235078

  • 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.

    PubMed 17585085

  • 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.

    PubMed 12656117

  • 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.

    PubMed 10782772

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Atherosclerosis, run by Stryker Neurovascular at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00929383, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2014; AzTrials last refreshed its copy on 8 Nov 2026.

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