Status:
COMPLETED
COMPLEX Post Market Surveillance Electronic Registry
Lead Sponsor:
Codman & Shurtleff
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
Phase:
NA
Brief Summary
To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the treatment of aneurysms.
Detailed Description
This Post Market Surveillance Registry collect baseline characteristics, aneurysmal features, procedural and follow-up information, and complications/adverse events on the performance intracranial ane...
Eligibility Criteria
Inclusion
- Patients with angiographically documented aneurysms,
- Either ruptured or unruptured,
- Aneurysm deemed by the attending neurointerventionalist to be acceptable candidates for endovascular embolization
Exclusion
- 1\) Patient / Treatment outside of the approved labeling, indications for use.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT00663299
Start Date
June 1 2004
End Date
May 1 2009
Last Update
May 17 2012
Active Locations (1)
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1
Kobe City General Hospital
Kobe, Japan, 650-0046