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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT00928265
First received: June 23, 2009
Last updated: May 31, 2013
Last verified: May 2013

June 23, 2009
May 31, 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 ] [ 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).
Not Provided
Complete list of historical versions of study NCT00928265 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
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
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00928265
SENAT
No
Stryker Neurovascular
Stryker Neurovascular
Not Provided
Principal Investigator: Alessandra Biondi
Principal Investigator: Alain Bonafé
Stryker Neurovascular
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP