Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06282939
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-11-06
Brief Title:
Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
Sponsor:
HCA Healthcare Research Institute
Organization:
HCA Healthcare Research Institute
Study Overview
Official Title:
Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMA
Brief Summary:
This is a prospective open-label consecutive enrollment multi-center US registry of patients with intracranial aneurysms who are treated with the Optima Coil System
The primary objective of this registry is to evaluate the safety and effectiveness of the OptimaTM Coil System including the OptiMAX Coils in the real-world treatment of intracranial aneurysms Imaging will be analyzed by a designated core neuroimaging lab to assess procedural success and aneurysm occlusion rates Intent to treat population total 700 patients 600 patients up to 100 screen failures
The primary objective of this registry is to evaluate the safety and effectiveness of the OptimaTM Coil System including the OptiMAX Coils in the real-world treatment of intracranial aneurysms Imaging will be analyzed by a designated core neuroimaging lab to assess procedural success and aneurysm occlusion rates Intent to treat population total 700 patients 600 patients up to 100 screen failures
Detailed Description:
The primary objective of this registry is to evaluate the safety and effectiveness of the OptimaTM Coil System including the OptiMAX Coils in the real-world treatment of intracranial aneurysms Imaging will be analyzed by a designated core neuroimaging lab to assess procedural success and aneurysm occlusion rates
The core lab will consist of 4-5 physicians 2-3 from within HCA Healthcare and 2-3 from outside of HCA Healthcare Core lab physicians will be blinded to patient characteristics for HIPAA compliance Physicians within the core lab will not be principal investigators enrolling patients in the study
600 subjects with intracranial saccular aneurysms maximum dimension 24 mm ruptured or unruptured treated with the OptimaTM Coil System
As this is a registry there will be no formal hypothesis testing of the study endpoints and no formal sample size power calculations will be performed
Approximately 600 subjects will be enrolled in the registry at up to 12 clinical sites in the US Data analyses will be performed and led by the study PIs Site PIs and Sub-investigators
Expected descriptive statistics will include baseline patient demographics procedural characteristics radiographic parameters safety outcomes clinical and efficacy outcomes Pilot univariate and multivariate logistic regression will be performed on the intention-to-treat cohort to identify predictors of adequate and complete aneurysm occlusion
The core lab will consist of 4-5 physicians 2-3 from within HCA Healthcare and 2-3 from outside of HCA Healthcare Core lab physicians will be blinded to patient characteristics for HIPAA compliance Physicians within the core lab will not be principal investigators enrolling patients in the study
600 subjects with intracranial saccular aneurysms maximum dimension 24 mm ruptured or unruptured treated with the OptimaTM Coil System
As this is a registry there will be no formal hypothesis testing of the study endpoints and no formal sample size power calculations will be performed
Approximately 600 subjects will be enrolled in the registry at up to 12 clinical sites in the US Data analyses will be performed and led by the study PIs Site PIs and Sub-investigators
Expected descriptive statistics will include baseline patient demographics procedural characteristics radiographic parameters safety outcomes clinical and efficacy outcomes Pilot univariate and multivariate logistic regression will be performed on the intention-to-treat cohort to identify predictors of adequate and complete aneurysm occlusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None