COMPLEX Post Market Surveillance Electronic Registry
To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the treatment of aneurysms.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||COMPLEX Post Market Surveillance Electronic Registry|
- To demonstrate performance of TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coils in the treatment of aneurysms [ Time Frame: Between 3-6 months ] [ Designated as safety issue: Yes ]
- Adverse events and product complaints [ Time Frame: Ongoing throughout study ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2004|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Trufill Detachable Coil System
There is only one treatment arm in the registry and it is all patients receiving treatment with Trufill Detachable Coil System. The use of bare platinum coils for the endovascular occlusion of cerebral aneurysms.
Device: Endovascular Embolization Device
The TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils are each an embolic coil system that consists of a platinum detachable coil, a delivery system (delivery tube and coil introducer) and a syringe. Each system has been designed to deliver, position and detach embolic coils in order to embolize intracranial aneurysms
Other Name: TRUFILL® DCS and TRUFILL DCS ORBIT Detachable Coils
This Post Market Surveillance Registry collect baseline characteristics, aneurysmal features, procedural and follow-up information, and complications/adverse events on the performance intracranial aneurysms treated with the Trufill DCS Orbit detachable platinum coils.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663299
|Kobe City General Hospital|
|Kobe, Japan, 650-0046|
|Principal Investigator:||Bernard Bendok, M.D.||Northwestern|