Clinical trial NCT06282939: Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
Official title: Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Aneurysm
Lead sponsor: HCA Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Balt USA
First posted: 2024-02-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 600 subjects with intracranial saccular aneurysms (maximum dimension ≤ 24 mm), ruptured or unruptured, treated with the OptimaTM Coil System.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

Patients enrolled in this registry must be treated in accordance with the FDA-cleared indication for the Optima Coil System.

In addition:

1. Patient age ≥ 18 years;
2. Candidate aneurysm is a previously untreated, saccular intracranial aneurysm measuring ≤ 24 mm in maximal diameter and suitable for embolization with coils;
3. OptimaTM coil system accounts for at least 75% of the total number of implanted coils;
4. Patient/ LARreceived the IRB-approved Consent Information Sheet to augment clinical procedure consent, and provided verbal consent to participate in the study
5. Subject willing to comply with the protocol follow-up requirements; and
6. Hunt \& Hess classification of equal to or less than 4 for ruptured aneurysms, if applicable.

Exclusion Criteria:

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.

1. Life expectancy less than 1 year.
2. Patient previously enrolled in the OPTIMA Registry.
3. 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.
4. 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.
5. Participation in another confirmed interventional clinical study that could confound the evaluation of this registry, per PI discretion.
6. Pre-planned staged procedures on unruptured target aneurysms

Primary outcomes:
measure: Measure Adequate Occlusion Using modified Raymond-Roy Occlusion Class (MRRC) I and II score
timeFrame: 1 year follow up +/- 90 days
measure: Assess coiling alone or in combination with adjunctive devices for approximately 400 patients
timeFrame: 1 year follow up +/- 90 days
measure: Evaluate Coiling with flow diversion for approximately 200 subjects
timeFrame: 1 year follow up +/- 90 days
measure: Subgroup analyses will be performed examining:
timeFrame: 1 year follow up +/- 90 days
measure: Analyze outcomes of small aneurysms defined as smaller than 5mm
timeFrame: 1 year follow up +/- 90 days
Secondary outcomes:
measure: Adequate occlusion
timeFrame: Immediate Post Procedure
measure: Packing density
timeFrame: Day 1
measure: Complete occlusion
timeFrame: 1 Year post- procedure
measure: Complete occlusion
timeFrame: Immediate post procedure
measure: Recanalization rate
timeFrame: 1 year post procedure
measure: Retreatment rate
timeFrame: 1 year post procedure
measure: Change in degree of disability
timeFrame: 1 year post procedure
measure: The number of coils used in an aneurysm
timeFrame: Upon enrollment
measure: Procedural fluoroscopic time
timeFrame: During procedure
Other outcomes:
measure: Primary Safety Endpoint
timeFrame: 7 days post-procedure or discharge
measure: Secondary Safety Endpoint
timeFrame: 12 months post enrollment
Locations:
city: Plano
country: United States
facility: Med City Plano
state: Texas
Study officials:
affiliation: HCA Research Institute
name: Albert Yoo
role: PRINCIPAL_INVESTIGATOR
References: