Intracranial AneurysmINSTANTNCT03642821
Intracranial Aneurysms Treatment With the OPTIMA Coil System
An observational study of Intracranial Aneurysm and Coiling Therapy, run by Balt Extrusion at 20 sites in 7 countries.
Trial summary
International, non-randomized, European , multicenter, observational study to collect data for the treatment of intracranial aneurysms with OPTIMA coils system to further document its safety and efficacy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm, Coiling Therapy
- What is being tested?
- intracranial aneurysm coiling
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 20 sitesin 7 countries
- Study dates
- 1 Mar 2019to 15 Feb 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. giant aneurysms (>25 mm) 2. recanalized aneurysms initially treated with stent or flow diverter (Only aneurysms initially treated with coils are eligible) 3. aneurysm treated with parent artery occlusion 4. dissecting or fusiform aneurysms 5. aneurysms associated with an arteriovenous malformation 6. aneurysm intended to be treated with flow diverter or flow disrupter during the procedure 7. aneurysm intended to be treated in a staged procedure 8. intracranial tumor (except meningioma) 9. Any condition or any situation that would prohibit the patient from coming to the investigational center for the follow-up, as requested according to sites current practice.
Who may be able to join
- Patient with small or large intracranial aneurysm, ruptured or unruptured, intended to be selectively treated with the OPTIMA coil system. Patients with recanalized aneurysms previously treated with coils exclusively are also eligible. Balloon and stent assisted coiling are allowed at index procedure.
- In case of multiple aneurysms, patient can be included when only 1 aneurysm is treated during the procedure and none of the other aneurysms are treated up to 30 days post-procedure
- Patient older than 18 years
- Patient who has been informed of the study and has signed an informed consent form where applicable according to local regulations.
Who cannot join
- -
Trial locations and contacts
20 sites in 7 countries.
20 sites in 7 countries
France9 sites
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, 33000
CHU de Brest - Hôpital La Cavale Blanche
Brest, 29200
Hospices Civils de Lyon - Hôpital Neurologique
Bron, 69677
CHU Côte de Nâcre
Caen, 14000
Hôpital Privé Clairval
Marseille, 13009
CHU Gui de Chaulliac
Montpellier, Costalat
CHU Hôpital Maison Blanche
Reims, 51000
CHU Charles-Nicolle
Rouen, 76000
CHRU Strasbourg Hautepierre
Strasbourg, 67200
Italy4 sites
Azienda Ospedallera
Catania, 95126
San Gerardo Hospital
Monza, 20900
Antonio Cardarelli Hospital
Naples, 80131
ULSS8 Berica Ospedale San Bortolo
Vicenza, 36100
Spain3 sites
Hospital Universitario de Burgos
Burgos, 09006
Hospital: Fundacion Jimenez Diaz
Madrid, 28222
Hospital: Puerta de Hierro
Madrid, 28222
Switzerland1 site
HUG Hôpital cantonal universitaire de geneva
Geneva, CH-1211
About this study
International, non-randomized, European , multicenter, observational study to collect data for the treatment of intracranial aneurysms with OPTIMA coils system to further document its safety and efficacy
- Conditions
- Intracranial Aneurysm, Coiling Therapy
- Being tested
- intracranial aneurysm coiling
- Keywords
- coil, aneurysm
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracranial aneurysm coilingDevice
Also called OPTIMA coils
endovascular treatment of intracranial aneurysm by coiling procedure using OPTIMA coils system
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbi-mortality at 30 days
Rate of adverse events including thromboembolic events, the bleeding/rebleeding episodes, the rate of retreated aneurysm and the rate of mortality occurring during the procedure and up to 30 days.
Measured: 30 days
Clinical outcomes (mRS) at 30 days
Classification of the patient clinical and neurological outcomes based on modified Rankin Scale from 0 (no symptoms a all) to 6 (dead). Global outcomes of mRS 0-2 are considered good and those of mRS 3-6 (including mRS 6 - deceased) are considered to be poor.
Measured: 30 days
Secondary outcomes (3)
Morbi-mortality at 12 months
Rate of adverse events including thromboembolic events, the bleeding/rebleeding episodes, the rate of retreated aneurysm and the rate of mortality occurring within 12 months after the procedure.
Measured: 12 months
Clinical outcomes (mRS) at 12 months
Classification of the patient clinical and neurological outcomes based on modified Rankin Scale from 0 (no symptoms a all) to 6 (dead). Global outcomes of mRS 0-2 are considered good and those of mRS 3-6 (including mRS 6 - deceased) are considered to be poor.
Measured: 12 months
Aneurysm occlusion rate
Post-procedure and 12-month follow-up efficacy based on the assessment of the aneurysm occlusion rate according to the 3-grade Montreal scale (complete occlusion/neck remnant/aneurysm remnant).
Measured: Up to 24h 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 posted22 Aug 2018
- Study start1 Mar 2019
- Primary completion13 Oct 2021
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Balt Extrusion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642821
- Sponsor's protocol ID
- CIP-201702-OPTIMA
- Acronym
- INSTANT
- Status last verified
- Sep 2025
- First submitted
- 10 Aug 2018
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracranial Aneurysms Treatment With the OPTIMA Coil System
- ClinicalTrials.gov ID
- NCT03642821
- Acronym / sponsor ID
- INSTANT / CIP-201702-OPTIMA
- Conditions
- Intracranial Aneurysm, Coiling Therapy
- Keywords
- coil, aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Balt ExtrusionIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 13 Oct 2021 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 22 Aug 2018 (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.
International, non-randomized, European , multicenter, observational study to collect data for the treatment of intracranial aneurysms with OPTIMA coils system to further document its safety and efficacy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. giant aneurysms (>25 mm) 2. recanalized aneurysms initially treated with stent or flow diverter (Only aneurysms initially treated with coils are eligible) 3. aneurysm treated with parent artery occlusion 4. dissecting or fusiform aneurysms 5. aneurysms associated with an arteriovenous malformation 6. aneurysm intended to be treated with flow diverter or flow disrupter during the procedure 7. aneurysm intended to be treated in a staged procedure 8. intracranial tumor (except meningioma) 9. Any condition or any situation that would prohibit the patient from coming to the investigational center for the follow-up, as requested according to sites current practice.
Key inclusion criteria (4 listed)
- Patient with small or large intracranial aneurysm, ruptured or unruptured, intended to be selectively treated with the OPTIMA coil system. Patients with recanalized aneurysms previously treated with coils exclusively are also eligible. Balloon and stent assisted coiling are allowed at index procedure.
- In case of multiple aneurysms, patient can be included when only 1 aneurysm is treated during the procedure and none of the other aneurysms are treated up to 30 days post-procedure
- Patient older than 18 years
- Patient who has been informed of the study and has signed an informed consent form where applicable according to local regulations.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| intracranial aneurysm coilingAlso: OPTIMA coilsendovascular treatment of intracranial aneurysm by coiling procedure using OPTIMA coils system | Device | – |
Primary outcome
Morbi-mortality at 30 days
Time frame: 30 days
Rate of adverse events including thromboembolic events, the bleeding/rebleeding episodes, the rate of retreated aneurysm and the rate of mortality occurring during the procedure and up to 30 days.
Clinical outcomes (mRS) at 30 days
Time frame: 30 days
Classification of the patient clinical and neurological outcomes based on modified Rankin Scale from 0 (no symptoms a all) to 6 (dead). Global outcomes of mRS 0-2 are considered good and those of mRS 3-6 (including mRS 6 - deceased) are considered to be poor.
3 secondary outcomes
Morbi-mortality at 12 months
Time frame: 12 months
Clinical outcomes (mRS) at 12 months
Time frame: 12 months
Aneurysm occlusion rate
Time frame: Up to 24h and 12 months
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 18 Sep 2025.
- Individual participant dataSharing planned: No
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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.
20 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm and Coiling Therapy, run by Balt Extrusion at 20 sites in 7 countries.
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 4 inclusion and 1 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 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, Italy, Spain, Austria, Germany and 2 more countries. 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?
Morbi-mortality at 30 days (time frame: 30 days). The study lists 2 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 18 Sep 2025.