Study Evaluating Safety and Effectiveness of Endovascular Treatment for Cerebral Aneurysms Using p64MW HPC and p48MW HPC Flow-Diverter Stents

What this Trial Is About

Researchers are evaluating the use of flow-diverting stents, specifically the p64MW HPC and p48MW HPC devices, for treating cerebral aneurysms. These devices have a coating designed to reduce the risk of blood clots, which can be a complication of this treatment. The study is observational and takes place in routine clinical settings across several Spanish hospitals to assess the effectiveness and safety of these devices over a one-year period. The study involves endovascular treatment where the flow-diverting stents are implanted to treat intracranial aneurysms or dissections. These devices have a hydrophilic polymer coating aimed at lowering thromboembolic complications. The study collects data during the procedure and continues with clinical and radiological follow-ups over twelve months to monitor outcomes and complications. Participants will undergo assessments to evaluate intervention success, thromboembolic and hemorrhagic complications, mortality, and clinical progression using scales such as the NIH Stroke Scale and Modified Rankin Scale. Additional monitoring includes imaging to evaluate aneurysm occlusion and ischemic complications at six months and one year. The total participation involves follow-ups for up to one year to measure both effectiveness and safety outcomes.

Prospective, Single-Arm, Multicenter Study to Evaluate the Effectiveness and Safety of Endovascular Treatment in Patients With Cerebral Aneurysms Using P64 and P48 Flow-Diverter Stents