Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment
SENAT
1 other identifier
observational
116
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2008
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 23, 2009
CompletedFirst Posted
Study publicly available on registry
June 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJune 4, 2013
May 1, 2013
2.2 years
June 23, 2009
May 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Efficacy of the Neuroform stent for treatment of wide neck aneurysms
post procedure and at 12-18 months post procedure
Interventions
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
Eligibility Criteria
Patient coming to the hospital to get an endovascular treatment of the aneurysm
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Centre Hospitalier pellegrin
Bordeaux, 33076, France
CHU Hôpital de la Côte de Nacre
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
Related Publications (13)
International subarachnoid aneurysms trials. lancet 2003 feb,1;361 (9355):430-1
BACKGROUNDAkpek 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.
PMID: 15891189BACKGROUNDAlfke 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.
PMID: 15090346BACKGROUNDBarath 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.
PMID: 15569741BACKGROUNDBenitez 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.
PMID: 15157292BACKGROUNDByrne 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.
PMID: 10663475BACKGROUNDCanton 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.
PMID: 16304994BACKGROUNDdos 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.
PMID: 15825550BACKGROUNDFiorella 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.
PMID: 14683536BACKGROUNDHowington 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.
PMID: 14683535BACKGROUNDLylyk 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.
PMID: 15739550BACKGROUNDMurayama 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.
PMID: 12744354BACKGROUNDWakhloo 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.
PMID: 9696095BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandra Biondi
- PRINCIPAL INVESTIGATOR
Alain Bonafé
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2009
First Posted
June 25, 2009
Study Start
July 1, 2008
Primary Completion
September 1, 2010
Study Completion
December 1, 2010
Last Updated
June 4, 2013
Record last verified: 2013-05