Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

Intracranial Aneurysm Clinical Trial

— OPTIMA  

Official title:

Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282939
• Other study ID #: 20234314
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

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