- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00663299
COMPLEX Post Market Surveillance Electronic Registry (COMPLEX)
May 15, 2012 updated by: Codman & Shurtleff
To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the treatment of aneurysms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
299
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kobe, Japan, 650-0046
- Kobe City General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with angiographically documented aneurysms,
- Either ruptured or unruptured,
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To demonstrate performance of TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coils in the treatment of aneurysms
Time Frame: Between 3-6 months
|
Between 3-6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events and product complaints
Time Frame: Ongoing throughout study
|
Ongoing throughout study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bernard Bendok, M.D., Northwestern
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
April 17, 2008
First Submitted That Met QC Criteria
April 21, 2008
First Posted (Estimate)
April 22, 2008
Study Record Updates
Last Update Posted (Estimate)
May 17, 2012
Last Update Submitted That Met QC Criteria
May 15, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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