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Trial record 1 of 1 for:    NCT03642821
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Intracranial Aneurysms Treatment With the OPTIMA Coil System (INSTANT)

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ClinicalTrials.gov Identifier: NCT03642821
Recruitment Status : Not yet recruiting
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Balt Extrusion

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

Condition or disease Intervention/treatment
Intracranial Aneurysm Device: intracranial aneurysm coiling

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Intracranial Aneurysms Treatment With the OPTIMA Coil System
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: intracranial aneurysm coiling
    endovascular treatment of intracranial aneurysm by coiling procedure using OPTIMA coils system
    Other Name: OPTIMA coils


Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03642821


Contacts
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Contact: Laure Coutrot +33130101863 laure.coutrot@balt.fr

Sponsors and Collaborators
Balt Extrusion

Additional Information:

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Responsible Party: Balt Extrusion
ClinicalTrials.gov Identifier: NCT03642821     History of Changes
Other Study ID Numbers: CIP-201702-OPTIMA
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases