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

Not Applicable

Active, not recruiting

• Conditions: Ruptured or Unruptured Cerebral Aneurysms
• Interventions: Device: TrelliX Embolic Coil System

• Registration Number: NCT03988062
• Lead Sponsor: Shape Memory Medical, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-21
• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-14
• Study First Posted: 2019-06-17
• Primary Completion: 2021-05-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-26
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TrelliX Embolic Coil System	TrelliX Embolic Coil System	-

Primary Outcome Measures

Name	Time	Method
Safety - Serious adverse events	30 days	Rate of freedom from incidence of serious adverse events related to the study
Efficacy - Angiographic occlusion	6 months and 12 months	Rate of angiographic occlusion based on Raymond-Ray grading scale \[1 No filling of aneurysm neck or dome; 2 Residual filling of aneurysm neck, not dome; 3 Residual filling of aneurysm neck and dome (worst outcome)\]

Trial Locations

Locations (2)

Hospital Clínico Regional Guillermo Grant Benavente; 🇨🇱 Concepción, Chile

Instituto de Neurocirugía; 🇨🇱 Santiago, Chile