RecruitingNCT06201598

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

Enrollment

100 participants

Start Date

Jan 12, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebral aneurysms.
  • Signed informed consent by the patient or their representative.

Exclusion Criteria4

  • Patients under 18 years of age.
  • Absence of signed informed consent by the patient or their representative.
  • Known, medically untreatable allergy to iodinated contrast.
  • Pregnant women or those breastfeeding.

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Interventions

DEVICEGroup 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

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NCT06201598


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