Clinical Research Directory

NOn-inVAsive Blood Pressure Monitoring in Intracranial Aneurysm Embolization

The goal of this clinical trial is to evaluate whether non-invasive continuous blood pressure monitoring (NVBP) using the ClearSight system can safely serve as an alternative to radial arterial catheterization for invasive arterial blood pressure monitoring (IABP) in patients undergoing coil embolization for unruptured intracranial aneurysms. The main questions it aims to answer are: * Does NVBP monitoring detect intraoperative hypotension and hypertension events with similar reliability compared to IABP? * Does NVBP monitoring reduce the need for invasive arterial catheterization without compromising patient safety or clinical outcomes? Researchers will compare patients assigned to NVBP monitoring with those receiving conventional IABP monitoring. Participants will: * Be randomly assigned to NVBP monitoring or standard IABP monitoring during coil embolization. * Receive continuous monitoring of cerebral oxygenation with near-infrared spectroscopy (rSO₂). * Undergo standard anesthesia induction, maintenance, and postoperative intensive care protocols. * Have their intraoperative hemodynamic events, vasopressor use, and postoperative outcomes recorded up to 30 days after the procedure.

Risk Analysis of Intracranial Aneurysm Rupture Through Social Determinants of Health

Intracranial aneurysms (IA) are arterial malformations affecting about 3% of the overall population. Rupture is the most severe complication, as it is associated with nearly 30% of death or severe disability. The available scores to assess rupture risk are mainly based on usual modifiable and non-modifiable risk factors from the literature, but they appear insufficient to predict rupture. Emerging factors, such as sleep apnea syndrome and the use of certain medications, seem to influence the risk of rupture. The study of social determinants of health (SDOH) is highly relevant, given numerous reports showing the impact of SDOH, in addition to vascular risk factors, on vascular diseases like ischemic stroke or myocardial infarction. It is therefore reasonable to study the interaction between rupture risk factors and SDOH on the rupture risk of IA. Several initiatives have been undertaken to assess rupture risk, but few have included SDH. Limitations were often raised, especially regarding data accessibility. However, it is now possible, thanks to artificial intelligence (AI) algorithms, particularly natural language processing (NLP), to reuse large-scale health data to address longstanding issues, such as those posed by SDH. The use of health data warehouses (HDWs) offers an opportunity to collect and analyze accurate, real-world data, particularly through AI and NLP to extract information from medical reports. However, various challenges limit the use of NLP models, notably the dominance of models trained on English medical texts and privacy-related legislative restrictions. Therefore, alongside leveraging these models for clinical research, it is essential to continue efforts to develop transparent French-language models that comply with legislation. Thus, the ARAMISS project proposes to study the interaction between SDH and known risk factors for IA rupture by comparing control populations and rupture cases. This study will be based on a certified health data warehouse (HDW) and an NLP algorithm previously developed by the team. In parallel, the project plans two FAIR-compliant knowledge-sharing approaches to disseminate the algorithm and training corpus to the broader community.

Targeting Real World Usage In Stroke Treatment

TRUST Registry is an observational, prospective, long-term, post-market surveillance registry of subjects treated with WallabyPhenox flow modulation devices, stent systems, bifurcation aneurysm implants including their HPC variants (Hydrophilic Polymer Coating) where applicable as well as coil systems, and other adjunctive medical devices. The overarching purpose of this registry is to carry out a proactive gathering, recording, and analysis of data on the safety, performance and usability of the devices as applied within the routine practice of the participating registry sites.

PC400 Coils for Treatment of Intracranial Aneurysms

The goal of this prospective, observational study is to evaluate the long-term occlusion rates and safety of the Penumbra PC400 coil in the treatment of ruptured and unruptured intracranial aneurysms in adult subjects ages 18-80. Specifically, the study aims to analyze rate of death, stroke, neurological death, or rebleeding associated with the treatment of intracranial aneurysm with the PC400 coil. Participants will undergo standard of care treatment and follow up for their aneurysm treatment, and participating sites will collect procedural and follow up data.

Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm

The Jacobs Institute is participating in a study designed to collect prospective clinical evidence to evaluate the approved use of the Pipeline™ Flex Embolization Device with Shield Technology™ for the endovascular treatment of adults (22 years of age or older) with wide-necked intracranial aneurysms

Screening in Relatives With Elevated Risk for Unruptured Intracranial Aneurysms

The purpose of this study is to screen first-degree relatives of patients with aneurysmal subarachnoid hemorrhage using magnetic resonance angiography to detect unruptured intracranial aneurysms. This study aims to identify individuals who are at increased risk and determine the effect of environmental factors for development of unruptured intracranial aneurysms.

Impact of Platelet Activation in Intracranial Aneurysm Rupture Risk - PLAQRAN

Sub arachnoid hemorrhage consecutive to intracranial aneurysm rupture is a devastating disease. Predictors of intracranial aneurysm rupture are limited and focus mainly on size and location. Platelet activation may have a deleterious role on aneurysm rupture. The assumption is that patients with ruptured intracranial aneurysm will present a higher rate of platelet activation compared to patients with non ruptured aneurysms.

Patients' Follow-up After Subarachnoid Haemorrhage Caused by Ruptured Intracranial Aneurysms

After endovascular treatment of the intracranial aneurysm, recanalization may occur, with a risk of recurrent subarachnoid haemorrhage or long-term angiographic recurrences of aneurysms. Few data exist on patients' long-term follow-up after subarachnoid haemorrhage caused by ruptured intracranial aneurysms.

ANEURYSM@RISK: Automatic Intracranial Aneurysm Quantification and Feature Learning Modelling to Optimize Intracranial Aneurysm Rupture Prediction

ANEURYSM@RISK is an observational study aiming to develop and validate an artificial intelligence (AI)-based prediction model for the growth and rupture of intracranial aneurysms (IAs). By applying automated 3D segmentation and morphological quantification of IAs from MR angiography (MRA) scans, the model is intended to provide clinicians with objective and reproducible risk estimates of aneurysm instability. The study utilizes retrospective imaging data from multiple European centers, including UMC Utrecht, AP-HP Paris, and University Medical Center Hamburg-Eppendorf (UKE). A clinical vignette study will evaluate the model's clinical utility and user experience among interventional radiologists. This study is exempt from medical ethics review (non-WMO in the Netherlands), as it involves only existing, anonymized data and imposes no additional burden on patients.

Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms

This is a multi-center, prospective, propensity matched twin armed study conducted on 50 patients in the experimental arm followed for 18 months after intervention evaluating cost effectiveness, safety and efficacy of therapy.

Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device

The proposed study is a multi-center single arm retrospective and prospective data collection, of patients treated with the LVIS device of specific sizes of 3.5mm, 4.0mm, 4.5mm, 5.5mm with up to 5 years follow-up. Information collected during the study will be standardized across centers to include pre-treatment baseline characteristics of patients including aneurysm(s) symptoms, procedural information, prespecified clinical safety events of interest, and follow-up imaging, clinical visits or telephone calls.

Evaluation of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms

The study is a prospective, multicenter single-arm cohort. The purpose of this study is to evaluate efficacy and safety of a novel intrasaccular embolization device for the treatment of intracranial aneurysms.

Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE

The aims of this clinical data collection are to investigate mortality, morbidity and neurological outcome 12 months after treatment of subject's intracranial aneurysm(s) and additionally to evaluate potential residual risks associated with the use of the commercial device(s) and to ensure the long-term safety and performance of Acandis Device(s) after its placing on the French market. On top of this, these cohorts will generate data for getting the renewal of the device's reimbursement on the French market.

Comparison of the Antiplatelet Efficacy of Aspirin Combined With Clopidogrel and Aspirin Combined With Half-dose Ticagrelor in Patients With Unruptured Intracranial Aneurysms With Normal CYP2C19 Metabolizer Phenotype

The goal of this clinical trial is to compare the antiplatelet efficacy of aspirin combined with clopidogrel and aspirin combined with half-dose ticagrelor in in patients with unruptured intracranial aneurysms with normal CYP2C19 metabolizer phenotype. The main questions it aims to answer are: If aspirin combined with half-dose ticagrelor is comparable to or better than aspirin combined with clopidogrel? What medical problems do participants have when taking aspirin combined with half-dose ticagrelor? Researchers will compare aspirin combined with half-dose ticagrelor to aspirin combined with clopidogrel to see if aspirin combined with half-dose ticagrelor works to treat patients with unruptured intracranial aneurysms received endovascular treatment. Participants will: Take aspirin combined with half-dose ticagrelor or aspirin combined with clopidogrel every day for 6 months Visit the clinic 1 month and 6 months for checkups and tests