NCT06201598

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Hospital Universitario Central de Asturias · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The use of flow-diverting stents for the endovascular treatment of cerebral aneurysms has proven to be effective and efficient in several clinical studies, leading to its widespread adoption. Devices with a higher number of filaments have a greater flow-diverting effect and less variation when there are changes in the caliber of the underlying vessel or in curved vessels. However, ischemic complications secondary to their implantation have been reported, prompting the development of various strategies to reduce their thrombogenicity. Phenox is the only company to date that has developed an anti-thrombogenic coating, known as HPC (Hydrophilic Polymer Coating), which, when applied to the p64 MW HPC and p48 MW HPC devices, has shown to reduce the likelihood of thromboembolic complications associated with their implantation.

Detailed description

The goal of this study is to evaluate the effectiveness and safety of endovascular treatment for cerebral aneurysms using the flow-diverting stents p64MW (flow modulation device) HPC and p48MW HPC in the routine clinical practice of several Spanish hospitals. It is therefore an observational study, carried out with devices already commercialized. The success rate of the intervention, the rate of hemorrhagic and thromboembolic complications, as well as variables related to the clinical and radiological follow-up of patients over a 12-month period, will be analyzed.

Conditions

• Cerebral Aneurysm
• Thromboembolic Disease

Interventions

Type	Name	Description
DEVICE	Group 1 - Intervention 1	Endovascular treatment of cerebral aneurysms through the implantation of p64MW HPC and p48MW HPC devices.

Timeline

• Start date: 2024-01-12
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2024-01-11
• Last updated: 2024-11-22

Locations

11 sites across 1 country: Spain