Actively Recruiting
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
Eligibility Criteria
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
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
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
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
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