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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
Sponsor: Hospital Universitario Central de Asturias
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2024-01-12
Completion Date
2025-12-15
Last Updated
2024-11-22
Healthy Volunteers
No
Conditions
Interventions
Group 1 - Intervention 1
Endovascular treatment of cerebral aneurysms through the implantation of p64MW HPC and p48MW HPC devices.
Locations (11)
Hospital Universitario de A Coruña
A Coruña, Spain
Hospital Universitari Germans Trias I Pujol
Badalona, Spain
Hospital Universitari Vall D Hebron
Barcelona, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Regional Universitario de Malaga
Málaga, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Parc Tauli
Sabadell, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain