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The IRISS study is designed to collect clinical and angiographic outcomes data when stenting intracranial atherosclerotic lesions using the Wingspanâ„¢ Stent System with Gatewayâ„¢ PTA Balloon Catheter in routine clinical practice.
The Wingspanâ„¢ Stent System and Gatewayâ„¢ 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 Wingspanâ„¢ Stent in a real world setting.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Wingspanâ„¢ 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Rate of Restenosis |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic intracranial atherosclerotic stenosis. Patients will be included who are eligible for endovascular treatment and for which treatment with the Wingspanâ„¢ Stent system has been judged necessary by the treating physician.
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Houdart | Principal Investigator | |
| Marius Hartmann | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Pellegrin | Bordeaux | 33076 | France | |||
| CHU Dijon-Hopital General |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7839388 | Background | 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. | |
| 2865674 | 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. |
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This was an open label registry (observational study). All patients scheduled for treatment with a Wingspan Stent meeting inclusion/exclusion criteria were eligible for participation.
Patients eligible were diagnosed with symptomatic Intracranial Atheroslcerotic disease and scheduled to be treated with a Wingspan Stent in 6 centers in France and 9 centers in Germany.
The first patient was enrolled on 11 March 2009 and last patient on 30 April 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Wingspan | Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 |
| Dijon |
| 21033 |
| France |
| CHU Limoges | Limoges | 87042 | France |
| Höpital Gui de Chauliac | Montpellier | 34059 | France |
| CHU Hôpital Guillaume et René Laënnec | Nantes | 44035 | France |
| Hôpital Saint-Roch | Nice | 06000 | France |
| Hôpital Lariboisière | Paris | 75010 | France |
| Fondation Rotschild | Paris | 75019 | France |
| CHU Reims | Reims | 51100 | France |
| CHU Toulouse | Toulouse | 31059 | France |
| Klinikum Augsburg | Augsburg | 86156 | Germany |
| Universitätsklinikum Dresden | Dresden | 1307 | Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | 40335 | Germany |
| Universitätsklinikum Erlangen | Erlangen | 91054 | Germany |
| Universitätsklinikum Essen | Essen | 45122 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Asklepios Klinik Altona | Hamburg | 22763 | Germany |
| Universitätsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| UKSH Campus Kiel | Kiel | 24105 | Germany |
| 15800226 | 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. |
| 16432056 | 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. |
| 10470816 | 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. |
| 16497979 | 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. |
| 15105508 | 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. |
| 17032860 | 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. |
| 17395864 | 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. |
| 17881980 | 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. |
| 18235078 | 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. |
| 17585085 | 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. |
| 12656117 | 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. |
| 10782772 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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Prospective, open label registry. All patients meeting inclusion/exclusion at the study centers were eligible for paritcipation.
As this was an observational registry, no statistical hypothesis was stated a priori.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Treated With a Wingspan Stent | Prospective, single arm, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Successful Wingspanâ„¢ 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. | (ITT) Intent-to-treat | Posted | Number | patients w stent implanted | Peri-procedural |
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| Primary | Cumulative Morbidity and Mortality Rate (Ischemic Event, Parenchymal Brain Hemorrhage, Subarachnoid or Intraventricular Hemorrhage or Death) | Any stroke or neurological death at \ | (ITT) Intent-to-treat | Posted | Number | participants | 30 days |
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| 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. | (ITT) Intent-to-treat | Posted | Number | participants | 12 Months |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | (ITT) Intent-to-treat | Posted | Number | participants | 12 months |
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| 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) | There were only N=77 patients available for analysis of restenosis at 12 months. This differs from the original N=82 ITT population in that denominator is based on the number of subjects available at 30 day follow up. Five subjects who exited the study at discharge were excluded from the analysis (no stent implanted (4), death (1)). | Posted | Number | participants | 12 Months |
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Adverse event data was collected from the procedure until last follow up visit (12 months).
Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wingspan | Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site | 29 | 82 | 5 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
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| Catheter site hematoma | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Multi-organ failure | General disorders | MedDRA 14.0 | Systematic Assessment |
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| In-stent arterial restenosis | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Hydrocephalus | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Neurological decompensation | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Renal cancer | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
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| Urethral cancer | Renal and urinary disorders | MedDRA 14.0 | Systematic Assessment |
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| Artery dissection | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Thrombosis in device | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 14.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Artery dissection | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Hess, Manager Clinical Affairs | Stryker Neurovascular | 1-510-413-2642 | david.hess@stryker.com |
| ID | Term |
|---|---|
| D002537 | Intracranial Arteriosclerosis |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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