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

December 18, 2025 updated by: Shape Memory Medical, Inc.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Concepción, Chile
        • Hospital Clínico Regional Guillermo Grant Benavente
      • Santiago, Chile
        • Instituto de Neurocirugía

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TrelliX Embolic Coil System
Device: TrelliX Embolic Coil System
Embolic coil with shape memory polymer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Serious adverse events
Time Frame: 30 days
Rate of freedom from incidence of serious adverse events related to the study
30 days
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)]
Immediate
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)]
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shape Memory Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2018

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

June 13, 2019

First Submitted That Met QC Criteria

June 14, 2019

First Posted (Actual)

June 17, 2019

Study Record Updates

Last Update Posted (Estimated)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD1003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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