Last updated: February 21, 2024
Sponsor: HCA Healthcare Research Institute
Overall Status: Active - Recruiting
Phase
N/A
Condition
Aneurysm
Treatment
OPTIMA and OPTIMAX Coils manufactured by Balt USA
Clinical Study ID
NCT06282939
20234314
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Patients enrolled in this registry must be treated in accordance with the FDA-clearedindication for the Optima Coil System. In addition:
- Patient age ≥ 18 years;
- Candidate aneurysm is a previously untreated, saccular intracranial aneurysm measuring ≤ 24 mm in maximal diameter and suitable for embolization with coils;
- OptimaTM coil system accounts for at least 75% of the total number of implanted coils;
- Patient/ LARreceived the IRB-approved Consent Information Sheet to augment clinicalprocedure consent, and provided verbal consent to participate in the study
- Subject willing to comply with the protocol follow-up requirements; and
- Hunt & Hess classification of equal to or less than 4 for ruptured aneurysms, ifapplicable.
Exclusion
Exclusion Criteria: Since this is a real-world registry, few exclusion criteria are defined. Adjustments forbaseline patient characteristics and aneurysm morphology will be used to identify outliersand unique cohorts.
- Life expectancy less than 1 year.
- Patient previously enrolled in the OPTIMA Registry.
- Known multiple intracranial aneurysms, apart from the targeted aneurysm for the OPTIMAstudy, requiring treatment during the index procedure or within the study follow-upperiod.
- Patient is unwilling or unable to comply with the protocol follow-up schedule and/orbased on the Investigator's judgment the patient is not a good registry candidate.
- Participation in another confirmed interventional clinical study that could confoundthe evaluation of this registry, per PI discretion.
- Pre-planned staged procedures on unruptured target aneurysms
Study Design
Total Participants: 600
Treatment Group(s): 1
Primary Treatment: OPTIMA and OPTIMAX Coils manufactured by Balt USA
Phase:
Study Start date:
November 01, 2023
Estimated Completion Date:
December 01, 2027
Study Description
Connect with a study center
Med City Plano
Plano, Texas 75075
United StatesActive - Recruiting
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