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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular treatment of intracranial aneurysm. | Device | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity and Mortality associated with stenting and coiling | Assessment of morbidity and mortality at 30 days and 12-18 months post endovascular treatment of wide neck aneurysm with a Neurform 3 stent and coiling as assessed by the modified Rankin scale (mRS). | 30 days and 12-18 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the Neuroform stent for treatment of wide neck aneurysms | Assessment of the morphological results post endovascular coiling and stenting of wide neck aneurysms and assessment of anatomical stability of the treatment at 12-18 months post procedure | post procedure and at 12-18 months post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patient coming to the hospital to get an endovascular treatment of the aneurysm
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| Name | Affiliation | Role |
|---|---|---|
| Alessandra Biondi | Principal Investigator | |
| Alain Bonafé | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier pellegrin | Bordeaux | 33076 | France | |||
| CHU Hôpital de la Côte de Nacre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | International subarachnoid aneurysms trials. lancet 2003 feb,1;361 (9355):430-1 | ||
| 15891189 | Background | 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. | |
| 15090346 |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Caen |
| 14033 |
| France |
| CHRU Salengro | Lille | 59037 | France |
| CHU Limoges | Limoges | 87042 | France |
| Hôpital Neurologique | Lyon | 69394 | France |
| Hôpital Gui de Chauliac | Montpellier | 34059 | France |
| CHU Nancy | Nancy | 54035 | France |
| CHU Hôpital Guillaume et René Laënnec | Nantes | 44035 | France |
| Hôpital Saint-Roch | Nice | 06000 | France |
| Hôpital Lariboisière | Paris | 75010 | France |
| Groupe Hospitalier Pitié-Salpétrière | Paris | 75013 | France |
| Fondation Rotschild | Paris | 75019 | France |
| Background |
| 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. |
| 15569741 | Background | 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. |
| 15157292 | Background | 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. |
| 10663475 | Background | 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. |
| 16304994 | Background | 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. |
| 15825550 | Background | 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. |
| 14683536 | Background | 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. |
| 14683535 | Background | 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. |
| 15739550 | Background | 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. |
| 12744354 | Background | 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. |
| 9696095 | Background | 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. |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |