Ruptured or Unruptured Cerebral AneurysmsAPEX-FIHNCT03988062
Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study
A study testing TrelliX Embolic Coil System in people with Ruptured or Unruptured Cerebral Aneurysms, run by Shape Memory Medical, Inc. at 2 sites in Chile.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ruptured or Unruptured Cerebral Aneurysms
- What is being tested?
- TrelliX Embolic Coil System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesChile
- Study dates
- 21 Nov 2018to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Hospital Clínico Regional Guillermo Grant Benavente
Concepción
Instituto de Neurocirugía
Santiago
About this 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
- Being tested
- TrelliX Embolic Coil System
- Medical subject headings
- Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrelliX Embolic Coil SystemDevice
Embolic coil with shape memory polymer
| Study group | Role | What they receive |
|---|---|---|
| TrelliX Embolic Coil System | Experimental | Not described Receives: Device: TrelliX Embolic Coil System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Serious adverse events
Rate of freedom from incidence of serious adverse events related to the study
Measured: 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)]
Measured: 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)]
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start21 Nov 2018
- Primary completion31 May 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ruptured or Unruptured Cerebral AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shape Memory Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03988062
- Sponsor's protocol ID
- CRD1003
- Acronym
- APEX-FIH
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2019
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study
- ClinicalTrials.gov ID
- NCT03988062
- Acronym / sponsor ID
- APEX-FIH / CRD1003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Shape Memory Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 17 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TrelliX Embolic Coil System | Experimental | Device: TrelliX Embolic Coil System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrelliX Embolic Coil SystemEmbolic coil with shape memory polymer | Device | TrelliX Embolic Coil System |
Primary outcome
Safety - Serious adverse events
Time frame: 30 days
Rate of freedom from incidence of serious adverse events related to the study
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)]
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)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TrelliX Embolic Coil System in people with Ruptured or Unruptured Cerebral Aneurysms, run by Shape Memory Medical, Inc. at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Serious adverse events (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.