Coiling Therapy, Intracranial Aneurysm
Conditions
Keywords
coil, aneurysm
Brief 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
Interventions
DEVICEintracranial aneurysm coiling
endovascular treatment of intracranial aneurysm by coiling procedure using OPTIMA coils system
Sponsors
Balt Extrusion
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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 3. Patient older than 18 years 4. Patient who has been informed of the study and has signed an informed consent form where applicable according to local regulations.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbi-mortality at 30 days | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbi-mortality at 12 months | 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. |
| Clinical outcomes (mRS) at 12 months | 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. |
| Aneurysm occlusion rate | Up to 24h and 12 months | 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). |
Countries
Austria, France, Germany, Italy, Latvia, Spain, Switzerland
Outcome results
None listed