Ruptured or Unruptured Cerebral Aneurysms
Conditions
Brief 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
Interventions
DEVICETrelliX Embolic Coil System
Embolic coil with shape memory polymer
Sponsors
Shape Memory Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Serious adverse events | 30 days | Rate of freedom from incidence of serious adverse events related to the study |
| Efficacy - Angiographic occlusion | Immediate | Rate of angiographic occlusion based on Raymond-Ray grading scale \[1 No filling of aneurysm neck or dome; 2 Residual filling of aneurysm neck, not dome; 3 Residual filling of aneurysm neck and dome (worst outcome)\] |
Countries
Chile
Outcome results
None listed