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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06282939
Other study ID # 20234314
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2023
Est. completion date December 1, 2027

Study information

Verified date February 2024
Source HCA Healthcare Research Institute
Contact Allison Kiser
Phone 812-617-5328
Email allison.kiser@hcahealthcare.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 1, 2027
Est. primary completion date December 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
OPTIMA and OPTIMAX Coils manufactured by Balt USA
*Percentage from protocol

Locations

Country Name City State
United States Med City Plano Plano Texas

Sponsors (2)

Lead Sponsor Collaborator
HCA Healthcare Research Institute Balt USA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Primary Safety Endpoint Device-related SAE 7 days post-procedure or discharge
Other Secondary Safety Endpoint Intraprocedural aneurysm perforation or rupture.
Intraprocedural symptomatic thromboembolic event.
All-cause mortality at 12 months post-procedure.
12 months post enrollment
Primary 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. 1 year follow up +/- 90 days
Primary Assess coiling alone or in combination with adjunctive devices for approximately 400 patients Subgroup using adjunctive devices include including balloon remodeling and stenting 1 year follow up +/- 90 days
Primary Evaluate Coiling with flow diversion for approximately 200 subjects Subgroup utilizing flow diverter for approximately 200 subjects 1 year follow up +/- 90 days
Primary 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 1 year follow up +/- 90 days
Primary Analyze outcomes of small aneurysms defined as smaller than 5mm Outcomes of small aneurysms defined as smaller than 5mm 1 year follow up +/- 90 days
Secondary Adequate occlusion Confirmed by core lab adjudication. Immediate Post Procedure
Secondary Packing density The percentage of coil volume to aneurysm volume using AngioSuite. Day 1
Secondary Complete occlusion Utilizing MRRC Class I 1 Year post- procedure
Secondary Complete occlusion Utilizing MRRC Class 1 Immediate post procedure
Secondary Recanalization rate Any worsening in aneurysm occlusion on the MRRC scale 1 year post procedure
Secondary Retreatment rate Retreatment of Target aneurysm 1 year post procedure
Secondary Change in degree of disability The proportion of patients with modified Rankin Scale score 0-2 (or at baseline score if >2) 1 year post procedure
Secondary The number of coils used in an aneurysm The number of coils used in an aneurysm stratified by aneurysm size. Upon enrollment
Secondary Procedural fluoroscopic time Procedural fluoroscopic time During procedure
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