Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment

Intracranial Aneurysm Clinical Trial

— SENAT  

Official title:

Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928265
• Other study ID #: SENAT
• Status: Completed
• Phase: N/A
• First received: June 23, 2009
• Last updated: May 31, 2013
• Start date: July 2008
• Est. completion date: December 2010

Study information

• Verified date: May 2013
• Source: Stryker Neurovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Haute Autorité de Santé Transparency CommissionFrance: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• 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

Locations

Country	Name	City	State
France	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	Fondation Rotschild	Paris
France	Groupe Hospitalier Pitié-Salpétrière	Paris
France	Hôpital Lariboisière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Neurovascular

Country where clinical trial is conducted

France, 

References & Publications (13)

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. — View Citation

Alfke K, Straube T, Dörner 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. — View Citation

Baráth K, Cassot F, Rüfenacht 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. — View 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. — View 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. — View Citation

Cantón 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. — View 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. — View 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. — View 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. — View Citation

Leung CH, Poon WS, Yu LM; International Subarachnoid Aneurysm Trial. The ISAT trial. Lancet. 2003 Feb 1;361(9355):430-1; author reply 432. — View Citation

Lylyk P, Ferrario A, Pasbón 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. — View Citation

Murayama Y, Nien YL, Duckwiler G, Gobin YP, Jahan R, Frazee J, Martin N, Viñuela F. Guglielmi detachable coil embolization of cerebral aneurysms: 11 years' experience. J Neurosurg. 2003 May;98(5):959-66. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No