COMPLEX Post Market Surveillance Electronic Registry (COMPLEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00663299
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : May 17, 2012
Information provided by (Responsible Party):
Codman & Shurtleff

April 17, 2008
April 22, 2008
May 17, 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 ]
Same as current
Complete list of historical versions of study NCT00663299 on Archive Site
Adverse events and product complaints [ Time Frame: Ongoing throughout study ]
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.
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (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 Identifier (NCT Number) in Medline.
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.

Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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