Intracranial AneurysmOPTIMANCT06282939
Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
An observational study of Intracranial Aneurysm, run by HCA Healthcare Research Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- OPTIMA and OPTIMAX Coils manufactured by Balt USA
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 1 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 600 subjects with intracranial saccular aneurysms (maximum dimension ≤ 24 mm), ruptured or unruptured, treated with the OptimaTM Coil System.
Who may be able to join
- 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.
Who cannot join
- 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.
- Patient previously enrolled in the OPTIMA Registry.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Med City Plano
Plano, Texas, 75075
Albert Yoo, 972-566-5411, ajyoo74@gmail.com
Pauline Matheri, 615-329-7274, Pauline.Matheri@HCAhealthcare.com
About this study
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.
Read the 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.
- Conditions
- Intracranial Aneurysm
- Being tested
- OPTIMA and OPTIMAX Coils manufactured by Balt USA
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIMA and OPTIMAX Coils manufactured by Balt USADevice
*Percentage from protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Adequate Occlusion Using modified Raymond-Roy Occlusion Class (MRRC) I and II score
Rated by a designated core lab without retreatment as confirmed by core lab adjudication.
Measured: 1 year follow up +/- 90 days
Assess coiling alone or in combination with adjunctive devices for approximately 400 patients
Subgroup using adjunctive devices include including balloon remodeling and stenting
Measured: 1 year follow up +/- 90 days
Evaluate Coiling with flow diversion for approximately 200 subjects
Subgroup utilizing flow diverter for approximately 200 subjects
Measured: 1 year follow up +/- 90 days
Subgroup analyses will be performed examining:
Aneurysms treated predominantly (≥50%) with Balt manufactured coils will also be analyzed for the number of coils utilized per aneurysm and procedure duration
Measured: 1 year follow up +/- 90 days
Analyze outcomes of small aneurysms defined as smaller than 5mm
Outcomes of small aneurysms defined as smaller than 5mm
Measured: 1 year follow up +/- 90 days
Secondary outcomes (9)
Adequate occlusion
Confirmed by core lab adjudication.
Measured: Immediate Post Procedure
Packing density
The percentage of coil volume to aneurysm volume using AngioSuite.
Measured: Day 1
Complete occlusion
Utilizing MRRC Class I
Measured: 1 Year post- procedure
Complete occlusion
Utilizing MRRC Class 1
Measured: Immediate post procedure
Recanalization rate
Any worsening in aneurysm occlusion on the MRRC scale
Measured: 1 year post procedure
Retreatment rate
Retreatment of Target aneurysm
Measured: 1 year post procedure
Change in degree of disability
The proportion of patients with modified Rankin Scale score 0-2 (or at baseline score if >2)
Measured: 1 year post procedure
The number of coils used in an aneurysm
The number of coils used in an aneurysm stratified by aneurysm size.
Measured: Upon enrollment
Procedural fluoroscopic time
Procedural fluoroscopic time
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Nov 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- HCA Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Balt USA
- Responsible party
- Sponsor
- Investigators
- Albert Yoo, Principal investigator, HCA Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282939
- Sponsor's protocol ID
- 20234314
- Acronym
- OPTIMA
- Status last verified
- Feb 2024
- First submitted
- 6 Nov 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
- ClinicalTrials.gov ID
- NCT06282939
- Acronym / sponsor ID
- OPTIMA / 20234314
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- HCA Healthcare Research InstituteUniversity, hospital or other
- Collaborators
- Balt USA
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 600 subjects with intracranial saccular aneurysms (maximum dimension ≤ 24 mm), ruptured or unruptured, treated with the OptimaTM Coil System.
Key inclusion criteria (8 listed)
- Patients enrolled in this registry must be treated in accordance with the FDA-cleared indication for the Optima Coil System.
- 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
Key exclusion criteria (7 listed)
- 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.
- Patient previously enrolled in the OPTIMA Registry.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPTIMA and OPTIMAX Coils manufactured by Balt USA*Percentage from protocol | Device | – |
Primary outcome
Measure Adequate Occlusion Using modified Raymond-Roy Occlusion Class (MRRC) I and II score
Time frame: 1 year follow up +/- 90 days
Rated by a designated core lab without retreatment as confirmed by core lab adjudication.
Assess coiling alone or in combination with adjunctive devices for approximately 400 patients
Time frame: 1 year follow up +/- 90 days
Subgroup using adjunctive devices include including balloon remodeling and stenting
Evaluate Coiling with flow diversion for approximately 200 subjects
Time frame: 1 year follow up +/- 90 days
Subgroup utilizing flow diverter for approximately 200 subjects
Subgroup analyses will be performed examining:
Time frame: 1 year follow up +/- 90 days
Aneurysms treated predominantly (≥50%) with Balt manufactured coils will also be analyzed for the number of coils utilized per aneurysm and procedure duration
Analyze outcomes of small aneurysms defined as smaller than 5mm
Time frame: 1 year follow up +/- 90 days
Outcomes of small aneurysms defined as smaller than 5mm
9 secondary outcomes
Adequate occlusion
Time frame: Immediate Post Procedure
Packing density
Time frame: Day 1
Complete occlusion
Time frame: 1 Year post- procedure
Complete occlusion
Time frame: Immediate post procedure
Recanalization rate
Time frame: 1 year post procedure
Retreatment rate
Time frame: 1 year post procedure
Change in degree of disability
Time frame: 1 year post procedure
The number of coils used in an aneurysm
Time frame: Upon enrollment
Procedural fluoroscopic time
Time frame: During procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Albert Yoo principal investigator
HCA Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by HCA Healthcare Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison Kiser (812-617-5328, allison.kiser@hcahealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure Adequate Occlusion Using modified Raymond-Roy Occlusion Class (MRRC) I and II score (time frame: 1 year follow up +/- 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.