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

NCT03988062 | Completed FDA Device

• 1 other identifier: CRD1003
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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

Conditions

Ruptured or Unruptured Cerebral Aneurysms

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

TrelliX Embolic Coil System

EXPERIMENTAL

Device: TrelliX Embolic Coil System

Interventions

TrelliX Embolic Coil System DEVICE

Embolic coil with shape memory polymer

TrelliX Embolic Coil System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shape Memory Medical, Inc.: lead

Study Sites (2)

Hospital Clínico Regional Guillermo Grant Benavente

Concepción, Chile

Location

Instituto de Neurocirugía

Santiago, Chile

Location

MeSH Terms

Conditions

Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: June 17, 2019
• Study Start: November 21, 2018
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2022
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (2)