Back to resultsCOMPLEX Post Market Surveillance Electronic Registry (COMPLEX)
Primary Purpose
Intracranial Aneurysm
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Endovascular Embolization Device
Sponsored by
About this trial
This is an interventional basic science trial for Intracranial Aneurysm focused on measuring Intracranial aneurysm
Eligibility Criteria
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.
Sites / Locations
- Kobe City General Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Trufill Detachable Coil System
Arm Description
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.
Outcomes
Primary Outcome Measures
To demonstrate performance of TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coils in the treatment of aneurysms
Secondary Outcome Measures
Adverse events and product complaints
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00663299
Brief Title
COMPLEX Post Market Surveillance Electronic Registry
Acronym
COMPLEX
Official Title
COMPLEX Post Market Surveillance Electronic Registry
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Codman & Shurtleff
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the treatment of aneurysms.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
Keywords
Intracranial aneurysm
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
299 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trufill Detachable Coil System
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
Endovascular Embolization Device
Other Intervention Name(s)
TRUFILL® DCS and TRUFILL DCS ORBIT Detachable Coils
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Adverse events and product complaints
Time Frame
Ongoing throughout study
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Bendok, M.D.
Organizational Affiliation
Northwestern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kobe City General Hospital
City
Kobe
ZIP/Postal Code
650-0046
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
18057282
Citation
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. doi: 10.1016/j.jvir.2007.07.020.
Results Reference
background
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COMPLEX Post Market Surveillance Electronic Registry
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