Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study

Study Overview
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Brief Summary
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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

Official Title
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Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study

Conditions
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Ruptured or Unruptured Cerebral Aneurysms

Intervention / Treatment
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* Device: TrelliX Embolic Coil System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TrelliX Embolic Coil System<br> | Device: TrelliX Embolic Coil System<br>* Embolic coil with shape memory polymer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Serious adverse events | Rate of freedom from incidence of serious adverse events related to the study | 30 days | 
| Efficacy - Angiographic occlusion | 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)] | Immediate | 
| Efficacy - Angiographic occlusion | 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)] | 6 months and 12 months |