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

Last updated: November 20, 2024
Sponsor: Hospital Universitario Central de Asturias
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Thromboembolism

Deep Vein Thrombosis

Treatment

Group 1 - Intervention 1

Clinical Study ID

NCT06201598
2023.014
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebralaneurysms.

  • Signed informed consent by the patient or their representative.

Exclusion

Exclusion Criteria:

  • 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.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Group 1 - Intervention 1
Phase:
Study Start date:
January 12, 2024
Estimated Completion Date:
December 15, 2025

Study 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.

Connect with a study center

  • Hospital Universitario de A Coruña

    A Coruña, 15006
    Spain

    Active - Recruiting

  • Hospital Universitari Germans Trias I Pujol

    Badalona, 08916
    Spain

    Active - Recruiting

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario de Burgos

    Burgos, 09006
    Spain

    Active - Recruiting

  • Hospital Universitario de Donostia

    Donostia, 20014
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, 33006
    Spain

    Active - Recruiting

  • Hospital Parc Tauli

    Sabadell, 08208
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003
    Spain

    Active - Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.