Status:
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
Lead Sponsor:
Hospital Universitario Central de Asturias
Conditions:
Cerebral Aneurysm
Thromboembolic Disease
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebral aneurysms.
- Signed informed consent by the patient or their representative.
Exclusion
- 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.
Key Trial Info
Start Date :
January 12 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 15 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06201598
Start Date
January 12 2024
End Date
December 15 2025
Last Update
November 22 2024
Active Locations (11)
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1
Hospital Universitario de A Coruña
A Coruña, Spain, 15006
2
Hospital Universitari Germans Trias I Pujol
Badalona, Spain, 08916
3
Hospital Universitari Vall D Hebron
Barcelona, Spain, 08035
4
Hospital Universitario de Burgos
Burgos, Spain, 09006