Status:
COMPLETED
Safety and Efficacy of Neuroform3TM for Intracranial Aneurysm Treatment
Lead Sponsor:
Stryker Neurovascular
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18+ years
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 tr...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00928265
Start Date
July 1 2008
End Date
December 1 2010
Last Update
June 4 2013
Active Locations (12)
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1
Centre Hospitalier pellegrin
Bordeaux, France, 33076
2
CHU Hôpital de la Côte de Nacre
Caen, France, 14033
3
CHRU Salengro
Lille, France, 59037
4
CHU Limoges
Limoges, France, 87042