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临床试验/NCT06189014
NCT06189014招募中不适用

The International PERForator ANeurysm Registry (PERFAN) - Natural History, Treatment, and Outcome of Intracranial Perforator Aneurysms

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年11月9日最近更新:
适应症

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

  1. 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.
  1. 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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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