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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Embolic coil with shape memory polymer
Hospital Clínico Regional Guillermo Grant Benavente
Concepción, Chile
Instituto de Neurocirugía
Santiago, Chile
Safety - Serious adverse events
Rate of freedom from incidence of serious adverse events related to the study
Time frame: 30 days
Efficacy - Angiographic occlusion
Rate of angiographic occlusion based on Raymond-Ray grading scale \[1 No filling of aneurysm neck or dome; 2 Residual filling of aneurysm neck, not dome; 3 Residual filling of aneurysm neck and dome (worst outcome)\]
Time frame: Immediate
Efficacy - Angiographic occlusion
Rate of angiographic occlusion based on Raymond-Ray grading scale \[1 No filling of aneurysm neck or dome; 2 Residual filling of aneurysm neck, not dome; 3 Residual filling of aneurysm neck and dome (worst outcome)\]
Time frame: 6 months and 12 months
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