The International PERForator ANeurysm Registry (PERFAN) - Natural History, Treatment, and Outcome of Intracranial Perforator Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- mRS at 3 months after initial diagnosis of an intracranial perforator aneurysm
研究概览
简要总结
The goal of this international, multicenter, mixed retrospective-prospective, exploratory, observational study is to establish an international registry to fill the knowledge gap created by the rarity of lenticulostriate and basilar perforator aneurysms and the resulting lack of knowledge about their natural history, diagnostic evaluation, management, and clinical outcomes. Specifically, comparative analyses of outcomes in patients with intracranial perforator aneurysms treated conservatively, endovascularly, and surgically will be performed. The study will also evaluate the size and location of lenticulostriate and basilar intracranial perforator aneurysms, collect information on the specific type of endovascular treatment used, compare patients with predominantly perimesencephalic subarachnoid hemorrhage (SAH) who have a perforator aneurysm to those without, and evaluate spontaneous occlusion in conservatively treated aneurysms. Core lab analysis of these aneurysms on various imaging modalities will be performed at the Inselspital and changes in aneurysm characteristics over time will be documented. In addition, the relationship between baseline characteristics and aneurysm characteristics on the incidence of hemorrhage will be examined. The study will involve approximately 20-30 centers worldwide with an estimated total sample size of 200-300 patients by 2025.
详细描述
- Background and current state of research
Lenticulostriate and basilar perforator aneurysms are extremely rare subtypes of intracranial aneurysms. Recent years have seen an increase in their diagnosis due to advancements in imaging technology. However, their low incidence has left a significant gap in the understanding of their natural history, diagnostic evaluation, management, and clinical outcomes. To date, the available literature consists mainly of case reports or small case series, with only a limited number of systematic reviews, such as those on lenticulostriate aneurysms (112 cases) and basilar perforator aneurysms (54 patients).
The most common presentation of perforator aneurysms is rupture, although unruptured aneurysms may be diagnosed as an incidental finding or as the cause of compressive symptoms. Initial angiography fails to identify approximately 30%-60% of perforator aneurysms. Various treatment approaches have been reported, including surgery and various endovascular techniques such as coiling, embolization with liquid embolic agents, flow-diverters, and even electrothrombosis with a microguidewire. However, all invasive strategies have inherent periprocedural risks that must be carefully weighed against the reported overall high rate of favorable outcomes in conservatively managed patients.
Despite the growing interest and knowledge in this field, an international multicenter registry that includes baseline patient characteristics, imaging, follow-up protocols, treatment strategies, and outcomes for both ruptured and unruptured intracranial perforator aneurysms is still lacking. 2. Research questions, hypotheses and aims
The research questions of this exploratory study are:
- To conduct a comparative analysis of clinical characteristics and outcomes among patients with intracranial lenticulostriate and basilar perforator aneurysms treated conservatively, endovascularly, and surgically.
- To assess the size and exact location of lenticulostriate and basilar intracranial perforator aneurysms.
- To gather information regarding the specific type of endovascular treatment employed.
- To compare patients with predominantly perimesencephalic SAH harboring a perforator aneurysm and those without an aneurysm.
- To investigate the occurrence of spontaneous occlusion in aneurysms treated conservatively.
- To perform a core lab analysis of lenticulostriate and basilar intracranial perforator aneurysms using different imaging modalities, including computed tomography (CT), magnetic resonance imaging (MRI), 2D digital subtraction angiography (DSA), and 3D DSA.
- To review and document observed changes of lenticulostriate and basilar perforator aneurysms (e.g. size) on follow-up imaging.
- To examine the association between aneurysm size and the incidence of bleeding.
- Methods
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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 from the Inselspital and from participating centers worldwide, who have been diagnosed or will be diagnosed with one or more lenticulostriate, basilar and/or other intracranial perforator aneurysms (starting from January 1st, 2013).
- •Patients aged ≥18 years
- •Written informed consent
排除标准
- •Presence of documented written or verbal refusal.
- •Aneurysm arising from the middle cerebral artery trunk which does not incorporate a lenticulostriate artery (Vargas Type 1), as they are not perforator aneurysms by strict definition.
- •Aneurysm arising from the basilar artery trunk adjacent to a perforating branch but not involving a perforating artery (Satti Type 1), as they are not perforator aneurysms by strict definition.
结局指标
主要结局
mRS at 3 months after initial diagnosis of an intracranial perforator aneurysm
时间窗: 90 days
Periprocedural and postprocedural complications in patients submitted to endovascular or surgical treatment
时间窗: Peri-/postprocedural, expected to be up to 24 hours
mRS at last follow-up (including time-point of last follow-up after diagnosis)
时间窗: Last follow-up, expected to be on average 2 years
Number of participants with ischemic stroke (imaging based)
时间窗: Follow-up, expected to be up to 7 days
Rupture/re-rupture of the index aneurysm as a time-event outcome
时间窗: Date of rupture/re-rupture
For patients receiving treatment, assessment of aneurysm occlusion after treatment and available follow-ups
时间窗: First follow-up, expected to be within 7 days
Death during the acute hospital stay
时间窗: Until patient discharge, up to 4 weeks
Death up to 90 days (related to the index aneurysm)
时间窗: 90 days
次要结局
未报告次要终点
