Clinical Research Directory

Development Platform Construction and Application Promotion of Drug-Eluting Stents for Intracranial Aneurysm Interventional Therapy

This study is a post-marketing clinical study of the Lattice Flow-Diverting Dense-Mesh Stent. It plans to enroll 280 patients, who will be treated for unruptured intracranial aneurysms using the Lattice Flow-Diverting Dense-Mesh Stent. Patients will be followed up at 12 months after device implantation, and data including the Raymond classification of the target aneurysms, the occurrence of complications, and whether complications result in neurological deficit symptoms will be collected and assessed. Through the above indicators, the clinical safety and efficacy of the product will be evaluated.

Impact of Life-size 3D Model on Patient Anxiety During Intracranial Aneurysms Embolization in Interventional Neuroradiology.

Intracranial aneurysm is a malformation of the cerebral arteries, identifying with a focal dilatation of the wall of an intracranial artery. This pathology is a fragility of the arterial wall which dilates abnormally creating ≪ a pocket ≫ where blood circulates under pressure. Due to their parietal fragility, aneurysms can grow or rupture. In addition, certain factors such as chronic arterial hypertension, smoking and chronic alcohol intoxication favor the risk of aneurysm rupture or growth. Cerebral aneurysm rupture has a serious prognosis: 10% of patients die before reaching hospital, 25% die within 24 hours, and 40-49% die within 3 months. Interventional neuroradiology offers treatment via an endovascular approach, by obstructing the aneurysm with coils and stents navigating within the arteries. This operation is not without risk of death or per-procedural stroke. In France, it is estimated that 5 to 7 patients per 100,000 of the population suffer a ruptured aneurysm, which means around 5,000 new cases every year. This figure does not take into account patients who die before accessing medical services. Interventional neuroradiology is a little-known discipline. Lack of knowledge about the activity, the professionals involved and the technologies involved, leads to anxiety among patients. Moreover, neurological pathologies are often physically undetectable. The investigators note a high degree of anxiety among patients on arrival at the department.However, it is difficult to explain the examination without support.That's why it would be interesting to build a simulation tool. The investigators note a high degree of anxiety among patients on arrival at the department. However, it is difficult to explain the examination without support. That's why it would be interesting to build a simulation tool. simulation tool to help explain the procedure: a 3D printer model of the vessels of a full-scale silicone model called the flow model, to be presented at the paramedical consultation for the experimental group. This will enable the patient to visualize the procedure and play an active role in it. The patient will therefore be able to benefit from all the information the procedure and the practices involved, understanding not only how the puncture is made and where, but also how it is arrived at. the aneurysm and how it is treated. In addition, visualizing the procedure will help patients to avoid the unknown, and make it easier to manage their anxiety. The flow model enables visualization of aneurysmal pathology in a simplified, concrete and didactic way for patients and the general public. At present, flow models of cerebral aneurysms have already been evaluated by some teams with a view to improving the information provided to the patient, in a non-randomized fashion and partially covering the operation. To our knowledge, there is no flow model reproducing the entire endovascular operative pathway from the puncture site (femoral or radial approach), the aorta and the graft to the aorta. the aorta, then the cervical arteries through to the cerebral aneurysm, has yet to be created and used. The major advantage of this modelization would be to simulate the entire procedure during the consultation, from puncture to placement of the stent and coils occluding the aneurysm. This project is particularly innovative, as it enables the patient to rationalize the procedure, potentially reducing his or her state of anxiety, and putting the patient and paramedical team in a practical situation to face up to the inherent risks of the operation. In addition, flow model simulation will enable the paramedical team to be trained in the practice of interventions. The ANXIFLOW project will therefore form the basis of a new handling training course for the continuing education of radiology technicians. This will involve preparing the radiology technicians to assist the doctor, preparing the equipment, disinfecting and laying the operating drapes, and anticipating the doctor's needs: prepared coils, micro-catheters, perfusion bag and purge circuit, etc.

Parent Artery Reconstruction for Small Unruptured Cerebral Aneurusms Using Flow DiverTers: a Multicenter Randomized Trial(PARAT-MT)

A prospective, multicenter, randomized controlled clinical trial with open-label treatment and blinded endpoint assessment.