Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study (NCT03988062) | Clinical Trial Compass
CompletedNot Applicable
Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study
Chile13 participantsStarted 2018-11-21
Plain-language summary
APEX-FIH is a first-in-human, open-label prospective multicenter study of the TrelliX Embolic Coil System for use in embolization of the medium to large, ruptured or unruptured cerebral aneurysms
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Subject age ≥18 and ≤80 years with a diagnosis of a ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure
* Aneurysm size \[largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen) ≥5 mm and ≤16mm
* If ruptured aneurysm: either WFNS grade 1 or 2, or Hunt and Hess 1 or 2
* If unruptured aneurysm: Subject grade Modified Rankin Scale mRS 0 - 2
* Investigator plans to use ≥70% in volume TrelliX coils to fill target aneurysm
Exclusion Criteria:
* Prior treatment (surgical or endovascular) of the target aneurysm
* Planned treatment of multiple aneurysms in index procedure
* Planned use of other modified coils (Matrix, HydroCoil or fibered coils)
* Planned use of liquid embolic material
* Life expectancy less than 12 months
* Presence of arteriovenous malformation
* Fusiform, mycotic, traumatic, or tumoral aneurysms
* Intended or planned aneurysm treatment by parent vessel occlusion
* Clipping or endovascular treatment of another intracranial aneurysm performed within 30 days before or planned within 30 days following the index procedure