Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189014
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-12-04
Brief Title:
The International PERForator ANeurysm Registry PERFAN
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
The International PERForator ANeurysm Registry PERFAN - Natural History Treatment and Outcome of Intracranial Perforator Aneurysms
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERFAN
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
Detailed Description:
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 eg size on follow-up imaging
To examine the association between aneurysm size and the incidence of bleeding
3 Methods
31 Study population
This is an international multicenter mixed-retrospective-prospective exploratory observational study
So far in Switzerland the Inselspital the University Hospital Basel the University Hospital Lausanne the Regional Hospital of Lugano and the Cantonal Hospital St Gallen are participating in this study and have received ethical approval In addition since the start of the study in early November 2023 already 15 international centers have expressed their interest in participating More centers worldwide will be contacted via a distribution list European Society of Minimally Invasive Neurological Therapy ESMINT Society of Neurointerventional Surgery SNIS and invited to participate The investigators estimate that approximately 20-30 centers worldwide will participate with an estimated total sample size of 200-300 patients by 2025 The analysis will be based on a survey see below for included data specifically designed for this study and completed by local neuroradiologists neurologists or neurosurgeons involved in the management of intracranial perforator aneurysms The primary treating physician will review the clinical records of patients with intracranial perforator aneurysms treated conservatively endovascularly or surgically Study lead and coordination as well as radiological and statistical analysis will be performed by the team at the Inselspital Bern Switzerland
32 Baseline characteristics imaging variables treatment variables and outcome variables
Data include
Age sex relevant comorbidities such as eg hypertension arteriovenous malformation AVM Moya-Moya initial clinical presentation incidental vs hemorrhagic In case of hemorrhagic presentation the type of bleeding SAH perimesencephalic subarachnoid hemorrhage pmSAH intraventricular hemorrhage IVH or intracerebral hemorrhage ICH will be documented
Type of initial diagnostic modality CT MRI DSA
Perforator aneurysm identified on initial diagnostic modality
Type of treatment surgical vs endovascular In case of endovascular treatment specific type coiling n-butyl cyanoacrylate NBCA ethylene vinyl alcohol EVOH flow-diverter Electro-coagulation other
Pre- and post-treatment modified Rankin Scale mRS
Clinical endpoints include
mRS at 3 months after initial diagnosis of an intracranial perforator aneurysm
mRS at last follow-up including time-point of last follow-up after diagnosis
Rupturere-rupture of the index aneurysm as a time-event outcome
Safety endpoints include
Death during the acute hospital stay
Death up to 90 days related to the index aneurysm
Ischemic stroke imaging based
Periprocedural and postprocedural complications in patients submitted to endovascular or surgical treatment
Efficacy Endpoint
For patients receiving treatment assessment of aneurysm occlusion after treatment and available follow-ups
33 Data transfer and storage Medical-Blocks and REDCap
Imaging data from all external participating centers will be securely transferred via and stored on Medical-Blocks httpsmb-neuromedical-blocksch This cloud-based platform for storage anonymization and exchange of medical images in the neuro field MB-Neuro is provided by the Inselspital Bern The platform provides the necessary interfaces to communicate with other secure and advanced IT environments via various Application Programming Interfaces APIs Secure Sockets Layers SSL with 256-bit encryption is used which complies with the regulations of KlinV Verordnung über klinische Versuche Art 18 and HFV Humanforschungsverordnung Art 5 of the Swiss Ordinance on the Storage of Health-Related Personal Data and Biological Materials The clinical datasets will be provided in an anonymized fashion matching the anonymized imaging data by the physician primarily involved in patient management from the participating centers and entered and stored in REDCap
4 Sample size and statistical analyses
This is an exploratory study The investigators estimate that approximately 20-30 centers worldwide will participate with an estimated total sample size of 200-300 patients
Categorical variables will be presented as numbers and percentages and continuous variables as medians interquartile range IQR Fishers exact will be used for categorical and Mann-Whitney U test or Kruskal-Wallis test for continuous variables Logistic regression results will be displayed as odds ratios OR for simple regression or adjusted OR aOR for multinomial regression analyses with their corresponding 95 confidence intervals CIs As this is an exploratory study no conclusions about significance can be drawn Therefore a p-value 005 will be interpreted as a trend All analyses will be performed using established statistic software including R 401 or newer Python 383 or newer Stata 16 andor Statistical Package for the Social Sciences SPSS 2700 or newer
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 eg size on follow-up imaging
To examine the association between aneurysm size and the incidence of bleeding
3 Methods
31 Study population
This is an international multicenter mixed-retrospective-prospective exploratory observational study
So far in Switzerland the Inselspital the University Hospital Basel the University Hospital Lausanne the Regional Hospital of Lugano and the Cantonal Hospital St Gallen are participating in this study and have received ethical approval In addition since the start of the study in early November 2023 already 15 international centers have expressed their interest in participating More centers worldwide will be contacted via a distribution list European Society of Minimally Invasive Neurological Therapy ESMINT Society of Neurointerventional Surgery SNIS and invited to participate The investigators estimate that approximately 20-30 centers worldwide will participate with an estimated total sample size of 200-300 patients by 2025 The analysis will be based on a survey see below for included data specifically designed for this study and completed by local neuroradiologists neurologists or neurosurgeons involved in the management of intracranial perforator aneurysms The primary treating physician will review the clinical records of patients with intracranial perforator aneurysms treated conservatively endovascularly or surgically Study lead and coordination as well as radiological and statistical analysis will be performed by the team at the Inselspital Bern Switzerland
32 Baseline characteristics imaging variables treatment variables and outcome variables
Data include
Age sex relevant comorbidities such as eg hypertension arteriovenous malformation AVM Moya-Moya initial clinical presentation incidental vs hemorrhagic In case of hemorrhagic presentation the type of bleeding SAH perimesencephalic subarachnoid hemorrhage pmSAH intraventricular hemorrhage IVH or intracerebral hemorrhage ICH will be documented
Type of initial diagnostic modality CT MRI DSA
Perforator aneurysm identified on initial diagnostic modality
Type of treatment surgical vs endovascular In case of endovascular treatment specific type coiling n-butyl cyanoacrylate NBCA ethylene vinyl alcohol EVOH flow-diverter Electro-coagulation other
Pre- and post-treatment modified Rankin Scale mRS
Clinical endpoints include
mRS at 3 months after initial diagnosis of an intracranial perforator aneurysm
mRS at last follow-up including time-point of last follow-up after diagnosis
Rupturere-rupture of the index aneurysm as a time-event outcome
Safety endpoints include
Death during the acute hospital stay
Death up to 90 days related to the index aneurysm
Ischemic stroke imaging based
Periprocedural and postprocedural complications in patients submitted to endovascular or surgical treatment
Efficacy Endpoint
For patients receiving treatment assessment of aneurysm occlusion after treatment and available follow-ups
33 Data transfer and storage Medical-Blocks and REDCap
Imaging data from all external participating centers will be securely transferred via and stored on Medical-Blocks httpsmb-neuromedical-blocksch This cloud-based platform for storage anonymization and exchange of medical images in the neuro field MB-Neuro is provided by the Inselspital Bern The platform provides the necessary interfaces to communicate with other secure and advanced IT environments via various Application Programming Interfaces APIs Secure Sockets Layers SSL with 256-bit encryption is used which complies with the regulations of KlinV Verordnung über klinische Versuche Art 18 and HFV Humanforschungsverordnung Art 5 of the Swiss Ordinance on the Storage of Health-Related Personal Data and Biological Materials The clinical datasets will be provided in an anonymized fashion matching the anonymized imaging data by the physician primarily involved in patient management from the participating centers and entered and stored in REDCap
4 Sample size and statistical analyses
This is an exploratory study The investigators estimate that approximately 20-30 centers worldwide will participate with an estimated total sample size of 200-300 patients
Categorical variables will be presented as numbers and percentages and continuous variables as medians interquartile range IQR Fishers exact will be used for categorical and Mann-Whitney U test or Kruskal-Wallis test for continuous variables Logistic regression results will be displayed as odds ratios OR for simple regression or adjusted OR aOR for multinomial regression analyses with their corresponding 95 confidence intervals CIs As this is an exploratory study no conclusions about significance can be drawn Therefore a p-value 005 will be interpreted as a trend All analyses will be performed using established statistic software including R 401 or newer Python 383 or newer Stata 16 andor Statistical Package for the Social Sciences SPSS 2700 or newer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None