Intracranial Aneurysm
Conditions
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.
Interventions
DEVICEOPTIMA and OPTIMAX Coils manufactured by Balt USA
\*Percentage from protocol
Sponsors
Balt USA
HCA Healthcare Research Institute
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analyze outcomes of small aneurysms defined as smaller than 5mm | 1 year follow up +/- 90 days | Outcomes of small aneurysms defined as smaller than 5mm |
| Subgroup analyses will be performed examining: | 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 |
| Measure Adequate Occlusion Using modified Raymond-Roy Occlusion Class (MRRC) I and II score | 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 | 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 | 1 year follow up +/- 90 days | Subgroup utilizing flow diverter for approximately 200 subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retreatment rate | 1 year post procedure | Retreatment of Target aneurysm |
| The number of coils used in an aneurysm | Upon enrollment | The number of coils used in an aneurysm stratified by aneurysm size. |
| Procedural fluoroscopic time | During procedure | Procedural fluoroscopic time |
| Change in degree of disability | 1 year post procedure | The proportion of patients with modified Rankin Scale score 0-2 (or at baseline score if \>2) |
| Adequate occlusion | Immediate Post Procedure | Confirmed by core lab adjudication. |
| Packing density | Day 1 | The percentage of coil volume to aneurysm volume using AngioSuite. |
| Complete occlusion | 1 Year post- procedure | Utilizing MRRC Class I |
| Recanalization rate | 1 year post procedure | Any worsening in aneurysm occlusion on the MRRC scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 7 days post-procedure or discharge | Device-related SAE |
| Secondary Safety Endpoint | 12 months post enrollment | 1. Intraprocedural aneurysm perforation or rupture. 2. Intraprocedural symptomatic thromboembolic event. 3. All-cause mortality at 12 months post-procedure. |
Countries
United States
Contacts
Primary ContactAllison Kiser
Backup ContactGina Remington
Outcome results
None listed