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
Key facts
- Where
- A Coruña, Badalona, Barcelona, Burgos, Donostia / San Sebastian, Madrid, Málaga, Oviedo, Sabadell, Valladolid, and Zaragoza, SpainSee the 11 sites
Where in Spain
- Hospital Universitario de A CorunaA Coruña, SpainContact: PEDRO VEGA VALDES, MD, PhDTaking people
- Hospital Universitari Germans Trias i PujolBadalona, SpainContact: PEDRO VEGA VALDES, MD, PhDTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainContact: PEDRO VEGA VALDES, MD, PhDTaking people
- Hospital Universitario De BurgosBurgos, SpainContact: PEDRO VEGA VALDES, MD, PhDTaking people
- Hospital Universitario de DonostiaDonostia / San Sebastian, SpainContact: PEDRO VEGA VALDES, MD, PhDTaking people
- Hospital Universitario La PazMadrid, SpainContact: PEDRO VEGA VALDES, MD, PhDTaking people
- Hospital Regional Universitario de MalagaMálaga, SpainContact: PEDRO VEGA VALDES, MD, PhDTaking people
- Hospital Universitario Central De AsturiasOviedo, SpainContact: PEDRO VEGA VALDES, MD, PhDTaking people
- Hospital Parc TauliSabadell, SpainContact: PEDRO VEGA VALDES, MD, PhDTaking people
- Hospital Clínico Universitario de ValladolidValladolid, SpainContact: PEDRO VEGA VALDES, MD, PhDTaking people
- Hospital Universitario Miguel ServetZaragoza, SpainContact: PEDRO VEGA VALDES, MD, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hospital Universitario Central de Asturias
- Trial code
- NCT06201598
- Record updated
- 22 November 2024
- Original description
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.Read full original descriptionShow less
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.
Inclusion: Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebral aneurysms; Signed informed consent by the patient or their representative.
Exclusion: Known, medically untreatable allergy to iodinated contrast; Patients under 18 years of age; Absence of signed informed consent by the patient or their representative; Pregnant women or those breastfeeding.