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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00928265
Recruitment Status : Completed
First Posted : June 25, 2009
Last Update Posted : June 4, 2013
Information provided by (Responsible Party):
Stryker Neurovascular

June 23, 2009
June 25, 2009
June 4, 2013
July 2008
September 2010   (Final data collection date for primary outcome measure)
Morbidity and Mortality associated with stenting and coiling [ Time Frame: 30 days and 12-18 months post procedure ]
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).
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Complete list of historical versions of study NCT00928265 on Archive Site
Efficacy of the Neuroform stent for treatment of wide neck aneurysms [ Time Frame: post procedure and at 12-18 months post procedure ]
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
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Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment
Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment

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.
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.
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
Patient coming to the hospital to get an endovascular treatment of the aneurysm
Intracranial Aneurysm
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

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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2010
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Stryker Neurovascular
Stryker Neurovascular
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Principal Investigator: Alessandra Biondi
Principal Investigator: Alain Bonafé
Stryker Neurovascular
May 2013