Status:
UNKNOWN
Appraising the Embolization of Aneurysms Using Balt Optima™ Coil System (APPLY Study)
Lead Sponsor:
Vascular Neurology of Southern California Inc.
Conditions:
Aneurysm
Intracranial Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In recent years, many developments have been made to the tools and techniques used to treat IAs via endovascular intervention. Specifically, to the detachable coils themselves. In March 2018, the US F...
Detailed Description
Intracranial aneurysms both ruptured and unruptured collectively affect a significant portion of the general population. Cases of unruptured intracranial aneurysms (UIA) are estimated to affect roughl...
Eligibility Criteria
Inclusion
- Patients age ≥ 18
- Patients undergoing the embolization of large or small intracranial aneurysms
- Patient's physician has decided that the best treatment for the patient's neurovascular abnormalities is the Optima Coil System and the patient has agreed to the treatment
- Of the total number of coils implanted Optima™ Coil System accounts for at least 80%
- Fully executed IRB approved Informed Consent
Exclusion
- Patient participation in another study that may disrupt the results of this study
- Anticipated life expectancy of less than 12-months
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 9 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04499508
Start Date
April 10 2020
End Date
April 9 2023
Last Update
April 26 2022
Active Locations (1)
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1
Vascular Neurology of Southern California
Thousand Oaks, California, United States, 91360