Intracranial Aneurysm
Conditions
Keywords
Intracranial aneurysm
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.
Interventions
DEVICEEndovascular 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
Sponsors
Codman & Shurtleff
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate performance of TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coils in the treatment of aneurysms | Between 3-6 months |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and product complaints | Ongoing throughout study |
Countries
Japan
Outcome results
None listed