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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Page 1 of 3 (12 locations)

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