Clinical Research Directory

Psychiatric Outcomes of Unruptured Intracranial Aneurysms (POUIA)

The impact of cerebrovascular procedures on patients experiencing anxiety and depression is not well studied despite the high prevalence of these mental health disorders. Unruptured Intracranial aneurysms (UIAs) have a prevalence of approximately 3% and an annual risk of 1-2% in the general population. Despite the high risk of fatality following aneurysm rupture with a rate of 40-50%, the overall aneurysm growth and rupture risks are rare (less than 3% per aneurysm per year) and many patients can be observed with serial follow-up imaging over years. Nevertheless, due to the gravity of the bad consequences of aneurysm rupture, simply informing many patients of UIA diagnosis has been found to result in worse outcomes of health-related quality of life. This study aims to investigate the impact of awareness of untreated UIA on the patients' mental health utilizing the Hospital Anxiety and Depression Scale (HADS) tool.

The TERUMO FRED X EARLY FEASIBILITY STUDY (FAST) STUDY.

The TERUMO FRED X EARLY FEASIBILITY STUDY (FAST) is a prospective, single-arm investigation.

Evaluating a Wireless NIRS Device in the Neonatal Intensive Care Unit

The wireless NIRS sensor will be placed on the participant's forehead, directly underneath the INVOS wired sensor. The wireless NIRS sensor will remain in place for 4 consecutive hours, over 2 consecutive days. As standard-of-care, nursing personnel removes all sensors at every care to evaluate skin and reduce the risk of pressure sores. The wireless NIRS device will be removed and reapplied at the same time, by the research team who will annotate what time the sensor was removed, replaced, and the condition of the skin. This will be used to correlate signal disconnection with sensor care (i.e., skin checks, sensor removal, etc.).

Interest of a Simulated Procedure Performed on a Printed Model in the Endovascular Treatment of Carotid-sylvian Aneurysms

It is now considered that 1% to 2% of the French population has an intracranial aneurysm. The major risk of this malformation is essentially the rupture which will lead in 10% of cases to death immediately, in 30% to 50% death within three weeks and in 30% of cases the patients will present a permanent disability. The management of this pathology represents today a major health challenge. Historically, neurosurgery was the discipline of first choice for the treatment of this pathology. This consists of clipping the aneurysm by a surgical approach to exclude it from the blood circulation and thus avoid its rupture. For many years now, interventional neuroradiology has established itself, through its "minimally invasive" and endovascular approach, as the reference treatment for ruptured and non-ruptured intracranial aneurysms: this is embolization. This so-called minimally invasive technique consists of placing directly into the aneurysm, using micro-catheters that are navigated under radiological control from the femoral artery, turns of plates called "coils" or prostheses called " stent" or "flow-diverter". This technique makes it possible to secure the aneurysm from the inside and thus reduce the risk of rupture. Today, 95% of patients are treated using this innovative technique and limited intraoperative risks. Interventional neuroradiology has constantly known in recent years a set of revolutions and innovations in terms of implantable medical devices (IMD) allowing to treat more and more patients with excellent clinical results. Today, the interventional neuroradiologist, assisted by the radiographer, has a very wide range of IMDs that he can combine with each other depending on the type, location, size and shape of the aneurysm. The role of the manipulator, here, is to work closely with the neuroradiologist so that he has, on the one hand, quality images and on the other hand, that he can count on a precious ally, an expert in IMDs, during embolization procedures. However, the wide choice of medical devices and the complexity of the aneurysms to be treated sometimes make treatment complicated. On the day of the "cold" treatment of the aneurysm (i.e. non-ruptured), the technicality of the catheterization and aneurysm's spatial conformation complicates the deployment of embolization equipment. This then sometimes leads to undesirable events such as intraoperative rupture. The very purpose of this study is to be able, by means of a 3D printer, to print the patient's aneurysm from the segmented 3D images obtained during the initial assessment and thus proceed to a simulation of the embolization procedure. This pre-operative planning (PPO) carried out in real conditions aims to anticipate the possible complications that could be encountered on the same day of treatment.

This Three-year Observational Study Involves Patients of All Ages Undergoing Endovascular Treatment for Various Cerebral or Spinal Vascular Conditions. It Aims to Assess Pre- and Post-operative Clinical Conditions, Report Complications, and Identify Preoperative Indicators of Treatment Outcomes. Pat

This three-year observational study involves patients of all ages undergoing endovascular treatment for various cerebral or spinal vascular conditions. It aims to assess pre- and post-operative clinical conditions, report complications, and identify preoperative indicators of treatment outcomes. Patients will also receive psychological support and Neuropsychological assessment. Clinical, medical, and demographic data will be recorded in a database during hospitalization and follow-up visits.

Perioperative Risk in Patients on Chronic Aspirin Undergoing Craniotomy

This study is looking at how taking aspirin regularly affects bleeding during and after brain surgery. Specifically, it focuses on patients who are having elective surgery to clip a brain aneurysm. Aspirin is commonly used to prevent heart attacks and strokes, but it can also increase the risk of bleeding. Doctors often face a tough decision: should patients stop taking aspirin before surgery to reduce bleeding risk, or continue it to prevent blood clots? To help answer this question, researchers will observe 100 patients, some who take aspirin regularly and some who don't, at hospitals in the U.S., Russia, and Italy. They will not change any treatments but will collect information about bleeding during surgery, blood test results, and CT scans after surgery. The goal is to better understand the risks of continuing aspirin and to help doctors make safer decisions for future patients.

LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan

The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms (IA). This is a single-arm, open-label, single-center, interventional study, screening patients approved for treatment of unruptured IAs based on national or international guidelines. Up to 10 eligible subjects meeting inclusion and exclusion criteria and providing consent will be enrolled in a Canadian site.

LUMENS-1 EU EFS CIP

The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms (IA). This is a prospective, single-arm, open-label, multi-center, interventional study, screening patients approved for treatment of unruptured IAs based on national or international guidelines. Up to 30 eligible subjects meeting inclusion and exclusion criteria and providing consent will be enrolled across a maximum of 10 medical centers in the EU.

Kaneka Endovascular Embolization and Protection

Prospective, multi-center, non-randomized registry / study, up to 164 patients enrolled and followed at 180 days +/- 45 days and again at 365 days +/- 90 days post procedure

Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices

To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of commercially available MicroVention devices used for the endovascular treatment of intracranial aneurysms (IA) at the direction of the treating physician.

Study to Evaluate the TUBE Device Ability to Treat Unruptured, Wide-neck or Fusiform Aneurysms

To assess the safety and performance of the TUBE device in the endovascular treatment of unruptured, wide-neck or fusiform intracranial aneurysms located on the internal carotid artery (ICA) or its branches

The Risk Factors Related to Rupture Flow-related Aneurysms in Posterior AVM

AVMs have been reported to rupture at a formidable annual rate of 2% to 3% at natural progression, often resulting in longterm neurological deficits and poor functional outcomes.The reported risk of hemorrhagic presentation in patients with AVMs is 41% to 65%. While many studies suggest a correlation between higher hemorrhage risk and the concurrent presence of AVM and aneurysms, few authors have focused specifically on flow-related aneurysms alone. In many instances, the source of rupture is also unclear. Meta-analysis from 2016 suggested that 49.2% of hemorrhages were secondary to aneurysm rupture, 45% from AVM rupture, and 5.7% were undetermined.In a study of 302 patients, of which 52.6% had a hemorrhagic presentation, demonstrated a significant increase in rate of hemorrhage in those with flow-related aneurysms. Thus, it is necessary to figure out risk factors related to ruptured flow-related aneurysms in pAVM.

Blood Pressure Treatment in ICU Patients with Subarachniodal Haemorrhage.

An MRI study to examine the relationship between blood pressure and cerebral blood flow in patients with subarachnoidal hemorrhage and suspect or verified vasospasm.