Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment (SENAT)
This study has been completed.
Sponsor:
Stryker Neurovascular
Information provided by (Responsible Party):
Stryker Neurovascular
ClinicalTrials.gov Identifier:
NCT00928265
First received: June 23, 2009
Last updated: April 5, 2013
Last verified: April 2013
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| First Received Date ICMJE | June 23, 2009 | ||||||||
| Last Updated Date | April 5, 2013 | ||||||||
| Start Date ICMJE | July 2008 | ||||||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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). |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00928265 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment | ||||||||
| Official Title ICMJE | Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment | ||||||||
| 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:
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patient coming to the hospital to get an endovascular treatment of the aneurysm |
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| Condition ICMJE | Intracranial Aneurysm | ||||||||
| Intervention ICMJE | 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:
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| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 116 | ||||||||
| Completion Date | December 2010 | ||||||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00928265 | ||||||||
| Other Study ID Numbers ICMJE | SENAT | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Stryker Neurovascular | ||||||||
| Study Sponsor ICMJE | Stryker Neurovascular | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Stryker Neurovascular | ||||||||
| Verification Date | April 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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