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COMPLEX Post Market Surveillance Electronic Registry (COMPLEX)

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ClinicalTrials.gov Identifier: NCT00663299
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : May 17, 2012
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff

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

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Device: Endovascular Embolization Device Not Applicable

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 aneurysms treated with the Trufill DCS Orbit detachable platinum coils.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 299 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: COMPLEX Post Market Surveillance Electronic Registry
Study Start Date : June 2004
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. To demonstrate performance of TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coils in the treatment of aneurysms [ Time Frame: Between 3-6 months ]

Secondary Outcome Measures :
  1. Adverse events and product complaints [ Time Frame: Ongoing throughout study ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663299


Locations
Japan
Kobe City General Hospital
Kobe, Japan, 650-0046
Sponsors and Collaborators
Codman & Shurtleff
Investigators
Principal Investigator: Bernard Bendok, M.D. Northwestern

Publications:
Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT00663299     History of Changes
Other Study ID Numbers: 03-2004
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: May 17, 2012
Last Verified: May 2012

Keywords provided by Codman & Shurtleff:
Intracranial aneurysm

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases