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New brain aneurysm coil shows promise in early safety trial

NCT ID NCT03988062

Disease control Sponsor: Shape Memory Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new expandable coil system for treating medium to large brain aneurysms (both ruptured and unruptured) in 13 adults. The goal was to see if the coil is safe and effectively blocks blood flow into the aneurysm. Results focused on serious side effects and how well the aneurysm was sealed off.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

13 people

The number who actually took part.

Started

Nov 2018

Finished

May 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

brain aneurysm Rupture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ruptured or unruptured cerebral aneurysms

Contacts and locations

Locations

  • Hospital Clínico Regional Guillermo Grant Benavente

    Concepción, Chile

  • Instituto de Neurocirugía

    Santiago, Chile