Actively Recruiting
Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
Led by HCA Healthcare Research Institute · Updated on 2024-02-28
600
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
H
HCA Healthcare Research Institute
Lead Sponsor
B
Balt USA
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, open-label, consecutive enrollment, multi-center, U.S. 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.
CONDITIONS
Official Title
Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be treated according to the FDA-cleared indication for the Optima Coil System
- Patient age 18 years or older
- A previously untreated, saccular intracranial aneurysm measuring 24 mm or less suitable for coil embolization
- At least 75% of implanted coils must be from the Optima Coil System
- Patient or legally authorized representative provided verbal consent and received IRB-approved consent information
- Patient willing to comply with study follow-up requirements
- Hunt & Hess classification of 4 or less for ruptured aneurysms, if applicable
You will not qualify if you...
- Life expectancy less than 1 year
- Previously enrolled in the OPTIMA Registry
- Known multiple intracranial aneurysms requiring treatment during the index procedure or follow-up, apart from the targeted aneurysm
- Unwilling or unable to comply with protocol follow-up schedule or deemed unsuitable by investigator
- Participation in another interventional clinical study that could interfere with this registry
- Pre-planned staged procedures on unruptured target aneurysms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Med City Plano
Plano, Texas, United States, 75075
Actively Recruiting
Research Team
A
Allison Kiser
CONTACT
G
Gina Remington
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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