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Completed

NCT Number: NCT03642821

Intracranial Aneurysms Treatment With the OPTIMA Coil System

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

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coiling Therapy Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Innsbruck, Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

-

Treatment and study plan

intracranial aneurysm coiling

Device

endovascular treatment of intracranial aneurysm by coiling procedure using OPTIMA coils system

Other names: OPTIMA coils

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Morbi-mortality at 12 months

    Time frame: 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.

  2. Clinical outcomes (mRS) at 12 months

    Time frame: 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.

  3. Aneurysm occlusion rate

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Balt Extrusion

Industry

Registry information

Acronym: INSTANT

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Aug 22, 2018
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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