Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment
NCT ID: NCT00928265
Last Updated: 2013-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
116 participants
OBSERVATIONAL
2008-07-31
2010-12-31
Brief Summary
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The objectives of this study are:
1. Assessment of morbidity-mortality at 1 month and 12-18 months following the treatment of the intracranial aneurysm with Neuroform3TM stent and endovascular coiling using the modified Rankin scale (mRS).
2. to evaluate adverse events.
3. Angiographic assessment at 12-18 months compared to the initial post-treatment assessment via the modified Raymond scale and same/better/worse scale.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Endovascular treatment of intracranial aneurysm.
Neuroform stent is used in conjunction of occlusives devices such as coils. Neuroform Stent allows the treatment of wide neck aneurysm with embolic coils. Put in front of the wide neck, it keeps the coils into the aneurysm and avoids them to fall in the parent artery, preventing coil protrusion.
Accomplishes this by providing coil support at the neck of the aneurysm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* every patient suffering from an un-ruptured or ruptured aneurysm, for whom the endovascular treatment approach using the Neuroform3TM stent is considered by the therapeutic team in charge.
* patient who has given his consent to participate to the study and to get his anonymized data collected
Exclusion Criteria
* treatment of several aneurysms in the same procedure, except adjacent aneurysm treated by the same stent
* severe vasospasm
* aneurysm associated with an arterio-venous malformation
* use of another Neuroform3TM stent
* woman pregnant or nursing
* patients not likely to be followed upon (living abroad)
* people protected by justice (safeguard of law, supervision or trusteeship)
* patient unsuitable to the anti-thrombotic and/or to anticoagulants therapies
18 Years
ALL
No
Sponsors
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Stryker Neurovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Alessandra Biondi
Role: PRINCIPAL_INVESTIGATOR
Alain Bonafé
Role: PRINCIPAL_INVESTIGATOR
Locations
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Centre Hospitalier pellegrin
Bordeaux, , France
CHU Hôpital de la Côte de Nacre
Caen, , France
CHRU Salengro
Lille, , France
CHU Limoges
Limoges, , France
Hôpital Neurologique
Lyon, , France
Hôpital Gui de Chauliac
Montpellier, , France
CHU Nancy
Nancy, , France
CHU Hôpital Guillaume et René Laënnec
Nantes, , France
Hôpital Saint-Roch
Nice, , France
Hôpital Lariboisière
Paris, , France
Groupe Hospitalier Pitié-Salpétrière
Paris, , France
Fondation Rotschild
Paris, , France
Countries
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References
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International subarachnoid aneurysms trials. lancet 2003 feb,1;361 (9355):430-1
Akpek S, Arat A, Morsi H, Klucznick RP, Strother CM, Mawad ME. Self-expandable stent-assisted coiling of wide-necked intracranial aneurysms: a single-center experience. AJNR Am J Neuroradiol. 2005 May;26(5):1223-31.
Alfke K, Straube T, Dorner L, Mehdorn HM, Jansen O. Treatment of intracranial broad-neck aneurysms with a new self-expanding stent and coil embolization. AJNR Am J Neuroradiol. 2004 Apr;25(4):584-91.
Barath K, Cassot F, Rufenacht DA, Fasel JH. Anatomically shaped internal carotid artery aneurysm in vitro model for flow analysis to evaluate stent effect. AJNR Am J Neuroradiol. 2004 Nov-Dec;25(10):1750-9.
Benitez RP, Silva MT, Klem J, Veznedaroglu E, Rosenwasser RH. Endovascular occlusion of wide-necked aneurysms with a new intracranial microstent (Neuroform) and detachable coils. Neurosurgery. 2004 Jun;54(6):1359-67; discussion 1368. doi: 10.1227/01.neu.0000124484.87635.cd.
Byrne JV, Bashiri M, Pasco A, Morris JH. A novel flexible endovascular stent for use in small and tortuous vessels. Neuroradiology. 2000 Jan;42(1):56-61. doi: 10.1007/s002340050015.
Canton G, Levy DI, Lasheras JC, Nelson PK. Flow changes caused by the sequential placement of stents across the neck of sidewall cerebral aneurysms. J Neurosurg. 2005 Nov;103(5):891-902. doi: 10.3171/jns.2005.103.5.0891.
dos Santos Souza MP, Agid R, Willinsky RA, Cusimano M, Montanera W, Wallace MC, terBrugge KG, Marotta TR. Microstent-assisted coiling for wide-necked intracranial aneurysms. Can J Neurol Sci. 2005 Feb;32(1):71-81. doi: 10.1017/s0317167100016917.
Fiorella D, Albuquerque FC, Han P, McDougall CG. Preliminary experience using the Neuroform stent for the treatment of cerebral aneurysms. Neurosurgery. 2004 Jan;54(1):6-16; discussion 16-7. doi: 10.1227/01.neu.0000097194.35781.ea.
Howington JU, Hanel RA, Harrigan MR, Levy EI, Guterman LR, Hopkins LN. The Neuroform stent, the first microcatheter-delivered stent for use in the intracranial circulation. Neurosurgery. 2004 Jan;54(1):2-5. doi: 10.1227/01.neu.0000099370.05758.4d. No abstract available.
Lylyk P, Ferrario A, Pasbon B, Miranda C, Doroszuk G. Buenos Aires experience with the Neuroform self-expanding stent for the treatment of intracranial aneurysms. J Neurosurg. 2005 Feb;102(2):235-41. doi: 10.3171/jns.2005.102.2.0235.
Murayama Y, Nien YL, Duckwiler G, Gobin YP, Jahan R, Frazee J, Martin N, Vinuela F. Guglielmi detachable coil embolization of cerebral aneurysms: 11 years' experience. J Neurosurg. 2003 May;98(5):959-66. doi: 10.3171/jns.2003.98.5.0959.
Wakhloo AK, Lanzino G, Lieber BB, Hopkins LN. Stents for intracranial aneurysms: the beginning of a new endovascular era? Neurosurgery. 1998 Aug;43(2):377-9. doi: 10.1097/00006123-199808000-00126. No abstract available.
Other Identifiers
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SENAT
Identifier Type: -
Identifier Source: org_study_id
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