Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment - Full Text View

Purpose

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:

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).
to evaluate adverse events.
Angiographic assessment at 12-18 months compared to the initial post-treatment assessment via the modified Raymond scale and same/better/worse scale.

Condition	Intervention
Intracranial Aneurysm	Device: Endovascular treatment of intracranial aneurysm.

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Brain Aneurysm

U.S. FDA Resources

Further study details as provided by Stryker Neurovascular:

Primary Outcome Measures:

Morbidity and Mortality associated with stenting and coiling [ Time Frame: 30 days and 12-18 months post procedure ] [ Designated as safety issue: Yes ]
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).

Secondary Outcome Measures:

Efficacy of the Neuroform stent for treatment of wide neck aneurysms [ Time Frame: post procedure and at 12-18 months post procedure ] [ Designated as safety issue: No ]
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

Enrollment:	116
Study Start Date:	July 2008
Study Completion Date:	December 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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 Names:

Neuroform3TM Microdelivery Stent System
M003E3250100,M003E3250150,M003E3250200,
M003E3300100,M003E3300150,M003E3300200,M003E3300300
M003E3350100,M003E3350150,M003E3350200,M003E3350300
M003E3400100,M003E3400150,M003E400200,M003E400300
M003E3450100,M003E3450150,M003E3450200,M003E3450300

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patient coming to the hospital to get an endovascular treatment of the aneurysm

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928265

Locations

France
Centre Hospitalier pellegrin
Bordeaux, France, 33076
CHU Hôpital de la Côte de Nacre
Caen, France, 14033
CHRU Salengro
Lille, France, 59037
CHU Limoges
Limoges, France, 87042
Hôpital Neurologique
Lyon, France, 69394
Hôpital Gui de Chauliac
Montpellier, France, 34059
CHU Nancy
Nancy, France, 54035
CHU Hôpital Guillaume et René Laënnec
Nantes, France, 44035
Hôpital Saint-Roch
Nice, France, 06000
Groupe Hospitalier Pitié-Salpétrière
Paris, France, 75013
Fondation Rotschild
Paris, France, 75019
Hôpital Lariboisière
Paris, France, 75010

Sponsors and Collaborators

Stryker Neurovascular

Investigators

Principal Investigator:	Alessandra Biondi
Principal Investigator:	Alain Bonafé

More Information

Publications:

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, 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.

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.

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.

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.

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.

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.

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.

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. No abstract available.

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.

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.

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. No abstract available.

Responsible Party:	Stryker Neurovascular
ClinicalTrials.gov Identifier:	NCT00928265 History of Changes
Other Study ID Numbers:	SENAT
Study First Received:	June 23, 2009
Last Updated:	April 5, 2013
Health Authority:	France: Haute Autorité de Santé Transparency Commission France: French Data Protection Authority

Keywords provided by Stryker Neurovascular:

intracranial
stenting
endovascular treatment
stent-assisted coiling
cerebrovascular disease

Additional relevant MeSH terms:

Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases

Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013

Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment (SENAT)