Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study (APEX-FIH)

Shape Memory Medical

Status

Completed

Conditions

Ruptured or Unruptured Cerebral Aneurysms

Treatments

Device: TrelliX Embolic Coil System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03988062

CRD1003

Details and patient eligibility

About

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

Enrollment

13 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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