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Completed

NCT Number: NCT03988062

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

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

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Key information

Conditions

Ruptured or Unruptured Cerebral Aneurysms Rupture Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Regional Guillermo Grant Benavente, Concepción, Chile

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TrelliX Embolic Coil System

Device

Embolic coil with shape memory polymer

Primary outcomes

  1. Safety - Serious adverse events

    Time frame: 30 days

    Rate of freedom from incidence of serious adverse events related to the study

  2. Efficacy - Angiographic occlusion

    Time frame: Immediate

    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)]

  3. Efficacy - Angiographic occlusion

    Time frame: 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)]

Sponsors and collaborators

Lead sponsor

Shape Memory Medical, Inc.

Industry

Registry information

Acronym: APEX-FIH

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jun 17, 2019
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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