Clinical trial NCT00928265: Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment
Official title: Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Keywords: intracranial
stenting
endovascular treatment
stent-assisted coiling
cerebrovascular disease
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient coming to the hospital to get an endovascular treatment of the aneurysm

Brief summary: This is a prospective observational multicenter registry to evaluate safety and efficacy data on Neuroform3TM stenting for treatment with endovascular coiling of wide neck aneurysms on an intent to treat basis.

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.

Detailed description: There is an increasing perception in the Neurovascular community - supported by extensive peer-to-peer and congress communications - that "stent-assisted coiling" of intracranial wide neck aneurysms improves the long term angiographic outcome of treated patients.

Eligibility criteria: Inclusion Criteria:

* 18 year's old patient or above.
* 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:

* patient with dissecting or fusiform aneurysm
* 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

Primary outcomes:
measure: Morbidity and Mortality associated with stenting and coiling
timeFrame: 30 days and 12-18 months post procedure
Secondary outcomes:
measure: Efficacy of the Neuroform stent for treatment of wide neck aneurysms
timeFrame: post procedure and at 12-18 months post procedure
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier pellegrin
city: Caen
country: France
facility: CHU Hôpital de la Côte de Nacre
city: Lille
country: France
facility: CHRU Salengro
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Hôpital Neurologique
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: CHU Hôpital Guillaume et René Laënnec
city: Nice
country: France
facility: Hôpital Saint-Roch
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpétrière
city: Paris
country: France
facility: Fondation Rotschild
Study officials:
name: Alessandra Biondi
role: PRINCIPAL_INVESTIGATOR
name: Alain Bonafé
role: PRINCIPAL_INVESTIGATOR
References:
citation: International subarachnoid aneurysms trials. lancet 2003 feb,1;361 (9355):430-1
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.