Observational Recruiting
NCT06189014 on ClinicalTrials.gov
The International PERForator ANeurysm Registry (PERFAN)
Official title: The International PERForator ANeurysm Registry (PERFAN) - Natural History, Treatment, and Outcome of Intracranial Perforator Aneurysms
- Sponsor: University Hospital of Bern
- Enrollment: 300 (Estimated)
- Study start: 2023-11-09 (Actual)
- Primary completion: 2025-12-31 (Estimated)
- Study completion: 2025-12-31 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
Brief Summary
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.
Conditions
- Aneurysm, Brain
Primary Outcome Measures
- mRS at 3 months after initial diagnosis of an intracranial perforator aneurysm (90 days)
- mRS at last follow-up (including time-point of last follow-up after diagnosis) (Last follow-up, expected to be on average 2 years)
- Rupture/re-rupture of the index aneurysm as a time-event outcome (Date of rupture/re-rupture)
- Death during the acute hospital stay (Until patient discharge, up to 4 weeks)
- Death up to 90 days (related to the index aneurysm) (90 days)
- Number of participants with ischemic stroke (imaging based) (Follow-up, expected to be up to 7 days)
- Periprocedural and postprocedural complications in patients submitted to endovascular or surgical treatment (Peri-/postprocedural, expected to be up to 24 hours)
- For patients receiving treatment, assessment of aneurysm occlusion after treatment and available follow-ups (First follow-up, expected to be within 7 days)
Countries
Switzerland
Locations and Investigators
-
Institute of Diagnostic and Interventional Neuroradiology, Inselspital Bern, Bern, Switzerland (Recruiting)
- Tomas Dobrocky, PD, MD
- Bettina Serrallach, MD
Study Officials
- Tomas Dobrocky, PD, MD (Principal Investigator) — Institute of Diagnostic and Interventional Neuroradiology, Inselspital Bern
- Johannes Kaesmacher, Prof, MD, PhD (Principal Investigator) — Institute of Diagnostic and Interventional Neuroradiology, Inselspital Bern
- Bettina L. Serrallach, MD (Principal Investigator) — Institute of Diagnostic and Interventional Neuroradiology, Inselspital Bern