COMPLEX Post Market Surveillance Electronic Registry
COMPLEX
1 other identifier
interventional
299
1 country
1
Brief Summary
To demonstrate performance of TRUFILL DCS and TRUFILL DCS ORBIT Detachable Coils in the treatment of aneurysms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 17, 2008
CompletedFirst Posted
Study publicly available on registry
April 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedMay 17, 2012
May 1, 2012
4.9 years
April 17, 2008
May 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To demonstrate performance of TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coils in the treatment of aneurysms
Between 3-6 months
Secondary Outcomes (1)
Adverse events and product complaints
Ongoing throughout study
Study Arms (1)
Trufill Detachable Coil System
OTHERThere 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients with angiographically documented aneurysms,
- Either ruptured or unruptured,
- Aneurysm deemed by the attending neurointerventionalist to be acceptable candidates for endovascular embolization
You may not qualify if:
- \) Patient / Treatment outside of the approved labeling, indications for use.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kobe City General Hospital
Kobe, 650-0046, Japan
Related Publications (1)
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.
PMID: 18057282BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bernard Bendok, M.D.
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2008
First Posted
April 22, 2008
Study Start
June 1, 2004
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
May 17, 2012
Record last verified: 2012-05