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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date August 10, 2018
First Posted Date August 22, 2018
Last Update Posted Date August 22, 2018
Estimated Study Start Date October 2018
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 21, 2018)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 21, 2018)
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Intracranial Aneurysms Treatment With the OPTIMA Coil System
Official Title Intracranial Aneurysms Treatment With the OPTIMA Coil System
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
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
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.
Condition Intracranial Aneurysm
Intervention Device: intracranial aneurysm coiling
endovascular treatment of intracranial aneurysm by coiling procedure using OPTIMA coils system
Other Name: OPTIMA coils
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 21, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility 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:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Laure Coutrot +33130101863 laure.coutrot@balt.fr
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03642821
Other Study ID Numbers CIP-201702-OPTIMA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Balt Extrusion
Study Sponsor Balt Extrusion
Collaborators Not Provided
Investigators Not Provided
PRS Account Balt Extrusion
Verification Date August 2018