Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Evaluate Coiling with flow diversion for approximately 200 subjects
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Evaluate Coiling with flow diversion for approximately 200 subjects
时间窗: 1 year follow up +/- 90 days
Subgroup utilizing flow diverter for approximately 200 subjects
Measure Adequate Occlusion Using modified Raymond-Roy Occlusion Class (MRRC) I and II score
时间窗: 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
时间窗: 1 year follow up +/- 90 days
Subgroup using adjunctive devices include including balloon remodeling and stenting
Subgroup analyses will be performed examining:
时间窗: 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
Analyze outcomes of small aneurysms defined as smaller than 5mm
时间窗: 1 year follow up +/- 90 days
Outcomes of small aneurysms defined as smaller than 5mm
次要结局
- Recanalization rate(1 year post procedure)
- Packing density(Day 1)
- Change in degree of disability(1 year post procedure)
- The number of coils used in an aneurysm(Upon enrollment)
- Adequate occlusion(Immediate Post Procedure)
- Retreatment rate(1 year post procedure)
- Procedural fluoroscopic time(During procedure)
- Complete occlusion(Immediate post procedure)