Recruiting

Observational Study

Sponsor:

HCA Healthcare Research Institute

Code:

NCT06282939

Conditions

Intracranial Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OPTIMA and OPTIMAX Coils manufactured by Balt USA

Study Details

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.

Conditions

Intracranial Aneurysm

Study ID

NCT06282939

Start date

Nov 1, 2023

Status verified date

Feb, 2024

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Interventions

OPTIMA and OPTIMAX Coils manufactured by Balt USA

\*Percentage from protocol

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 ]
  • Assess coiling alone or in combination with adjunctive devices for approximately 400 patients [ Time Frame: 1 year follow up +/- 90 days ]
  • Evaluate Coiling with flow diversion for approximately 200 subjects [ Time Frame: 1 year follow up +/- 90 days ]
  • Subgroup analyses will be performed examining: [ Time Frame: 1 year follow up +/- 90 days ]
  • Analyze outcomes of small aneurysms defined as smaller than 5mm [ Time Frame: 1 year follow up +/- 90 days ]

Central Contacts and Locations

Locations

Med City Plano

Recruiting

Plano, Texas, United States, 75075

Contacts

More Information

Sponsor

HCA Healthcare Research Institute

Last update posted

Feb 28, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by HCA Healthcare Research Institute on 2024-02-28.