Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство OPTIMA and OPTIMAX Coils manufactured by Balt USA
  \*Percentage from protocol

Первичные конечные точки

• Measure Adequate Occlusion Using modified Raymond-Roy Occlusion Class (MRRC) I and II score [Срок оценки: 1 year follow up +/- 90 days]
• Assess coiling alone or in combination with adjunctive devices for approximately 400 patients [Срок оценки: 1 year follow up +/- 90 days]
• Evaluate Coiling with flow diversion for approximately 200 subjects [Срок оценки: 1 year follow up +/- 90 days]
• Subgroup analyses will be performed examining: [Срок оценки: 1 year follow up +/- 90 days]
• Analyze outcomes of small aneurysms defined as smaller than 5mm [Срок оценки: 1 year follow up +/- 90 days]

Вторичные конечные точки (9)

• Adequate occlusion [Срок оценки: Immediate Post Procedure]
• Packing density [Срок оценки: Day 1]
• Complete occlusion [Срок оценки: 1 Year post- procedure]
• Complete occlusion [Срок оценки: Immediate post procedure]
• Recanalization rate [Срок оценки: 1 year post procedure]
• Retreatment rate [Срок оценки: 1 year post procedure]
• Change in degree of disability [Срок оценки: 1 year post procedure]
• The number of coils used in an aneurysm [Срок оценки: Upon enrollment]
• Procedural fluoroscopic time [Срок оценки: During procedure]

Критерии участия

Критерии включения

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

In addition:

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

Критерии исключения

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.

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• Med City Plano — Plano

Идентификаторы

NCT: NCT06282939 · 20234314

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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