Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
Key facts
- Where
- Plano, United StatesSee the site
Where in United States
- Med City PlanoPlano, United StatesContact: Albert YooTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- HCA Healthcare Research Institute
- Trial code
- NCT06282939
- Record updated
- 28 February 2024
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Patients enrolled in this registry must be treated in accordance with the FDA-cleared indication 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 clinical procedure 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, if applicable.
Exclusion: Patient previously enrolled in the OPTIMA Registry; Since this is a real-world registry, few exclusion criteria are defined. Adjustments for baseline patient characteristics and aneurysm morphology will be used to identify outliers and unique cohorts; Life expectancy less than 1 year; Known multiple intracranial aneurysms, apart from the targeted aneurysm for the OPTIMA study, requiring treatment during the index procedure or within the study follow-up period; Patient is unwilling or unable to comply with the protocol follow-up schedule and/or based on the Investigator's judgment the patient is not a good registry candidate; Participation in another confirmed interventional clinical study that could confound the evaluation of this registry, per PI discretion; Pre-planned staged procedures on unruptured target aneurysms.