Intracranial Aneurysms Treatment With the OPTIMA Coil System (INSTANT)

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 Overview

• Status: Completed
• Conditions: Intracranial Aneurysm; Coiling Therapy
• Intervention / Treatment: Device: intracranial aneurysm coiling

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, A-6020
    • Medizinische Universität Innsbruck
• France
  • Bordeaux, France, 33000
    • CHU de Bordeaux - Hôpital Pellegrin
  • Brest, France, 29200
    • CHU de Brest - Hôpital La Cavale Blanche
  • Bron, France, 69677
    • Hospices Civils de Lyon - Hôpital Neurologique
  • Caen, France, 14000
    • CHU Côte de Nacre
  • Marseille, France, 13009
    • Hopital Prive Clairval
  • Montpellier, France, Costalat
    • CHU Gui de Chaulliac
  • Reims, France, 51000
    • CHU Hôpital Maison Blanche
  • Rouen, France, 76000
    • CHU Charles-Nicolle
  • Strasbourg, France, 67200
    • CHRU Strasbourg Hautepierre
• Germany
  • Augsburg, Germany, 86156
    • Zentralklinikum Augsburg
• Italy
  • Catania, Italy, 95126
    • Azienda Ospedallera
  • Monza, Italy, 20900
    • San Gerardo Hospital
  • Napoli, Italy, 80131
    • Antonio Cardarelli Hospital
  • Vicenza, Italy, 36100
    • ULSS8 Berica Ospedale San Bortolo
• Latvia
  • Riga, Latvia
    • University of Latvia, Faculty of Medicine
• Spain
  • Burgos, Spain, 09006
    • Hospital Universitario de Burgos
  • Madrid, Spain, 28222
    • Hospital: Fundacion Jimenez Diaz
  • Madrid, Spain, 28222
    • Hospital: Puerta de Hierro
• Switzerland
  • Geneva, Switzerland, CH-1211
    • HUG Hôpital cantonal universitaire de geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	Up to 24h and 12 months

Collaborators and Investigators

• Sponsor: Balt Extrusion

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): October 13, 2021
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: aneurysm; coil
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CIP-201702-OPTIMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No