Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Shape Memory Medical, Inc.
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Safety - Serious adverse events
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
TrelliX Embolic Coil System
Intervention: TrelliX Embolic Coil System (Device)
Outcomes
Primary Outcomes
Safety - Serious adverse events
Time Frame: 30 days
Rate of freedom from incidence of serious adverse events related to the study
Efficacy - Angiographic occlusion
Time Frame: 6 months and 12 months
Rate of angiographic occlusion based on Raymond-Ray grading scale \[1 No filling of aneurysm neck or dome; 2 Residual filling of aneurysm neck, not dome; 3 Residual filling of aneurysm neck and dome (worst outcome)\]
Efficacy - Angiographic occlusion
Time Frame: Immediate
Rate of angiographic occlusion based on Raymond-Ray grading scale \[1 No filling of aneurysm neck or dome; 2 Residual filling of aneurysm neck, not dome; 3 Residual filling of aneurysm neck and dome (worst outcome)\]
Secondary Outcomes
No secondary outcomes reported