Actively Recruiting

Age: 18Years +
All Genders
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

Led by Hospital Universitario Central de Asturias · Updated on 2024-11-22

100

Participants Needed

11

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebral aneurysms
  • Signed informed consent by the patient or their representative
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 11 locations

1

Hospital Universitario de A Coruña

A Coruña, Spain, 15006

Actively Recruiting

2

Hospital Universitari Germans Trias I Pujol

Badalona, Spain, 08916

Actively Recruiting

3

Hospital Universitari Vall D Hebron

Barcelona, Spain, 08035

Actively Recruiting

4

Hospital Universitario de Burgos

Burgos, Spain, 09006

Actively Recruiting

5

Hospital Universitario de Donostia

Donostia / San Sebastian, Spain, 20014

Actively Recruiting

6

Hospital Universitario La Paz

Madrid, Spain, 28046

Actively Recruiting

7

Hospital Regional Universitario de Malaga

Málaga, Spain, 29010

Actively Recruiting

8

Hospital Universitario Central de Asturias

Oviedo, Spain, 33006

Actively Recruiting

9

Hospital Parc Tauli

Sabadell, Spain, 08208

Actively Recruiting

10

Hospital Clínico Universitario de Valladolid

Valladolid, Spain, 47003

Actively Recruiting

11

Hospital Universitario Miguel Servet

Zaragoza, Spain, 50009

Actively Recruiting

Loading map...

Research Team

P

PEDRO VEGA VALDES, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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 | DecenTrialz