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

NCT03988062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-12-22

No results posted yet for this study

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

Interventions

DEVICE

TrelliX Embolic Coil System

Embolic coil with shape memory polymer

Sponsors & Collaborators

  • Shape Memory Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-21
Primary Completion
2021-05-31
Completion
2022-05-31
FDA Device
Yes

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03988062 on ClinicalTrials.gov