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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

Recruitingn/aAges 18 Years - anyAllHospital Universitario Central de Asturias
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebral aneurysms. * Signed informed consent by the patient or their representative. 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.
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What it tests

  • Group 1 - Intervention 1
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Where

11 sites
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

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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