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COMPLEX Post Market Surveillance Electronic Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT00663299
First received: April 17, 2008
Last updated: May 15, 2012
Last verified: May 2012

April 17, 2008
May 15, 2012
June 2004
May 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00663299 on ClinicalTrials.gov Archive Site
Adverse events and product complaints [ Time Frame: Ongoing throughout study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
COMPLEX Post Market Surveillance Electronic Registry
COMPLEX Post Market Surveillance Electronic Registry

To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the treatment of aneurysms.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Intracranial Aneurysm
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
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.
Intervention: Device: Endovascular Embolization Device
Hirsch JA, Bendok BR, Paulsen RD, Cognard C, Campos J, Cronqvist M. Midterm clinical experience with a complex-shaped detachable platinum coil system for the treatment of cerebral aneurysms: Trufill DCS Orbit detachable coil system registry interim results. J Vasc Interv Radiol. 2007 Dec;18(12):1487-94.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
299
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with angiographically documented aneurysms,
  2. Either ruptured or unruptured,
  3. Aneurysm deemed by the attending neurointerventionalist to be acceptable candidates for endovascular embolization

Exclusion Criteria:

1) Patient / Treatment outside of the approved labeling, indications for use.

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00663299
03-2004
No
Codman & Shurtleff
Codman & Shurtleff
Not Provided
Principal Investigator: Bernard Bendok, M.D. Northwestern
Codman & Shurtleff
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP