About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebral aneurysms.
Signed informed consent by the patient or their representative.
Disqualifiers
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.
Trial population
The study will include all patients with intracranial aneurysms or dissections suitable for endovascular treatment with a flow-diverting device, who attend the participating hospitals.
Trial design
Case-only
Prospective
Treatments tested in this trial
Group 1 - Intervention 1
DeviceEndovascular treatment of cerebral aneurysms through the implantation of p64MW HPC and p48MW HPC devices.
Treatment groups
Trial outcomes
Primary outcomes
Effectiveness objective
Evaluation of the effectiveness of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.
Safety Objective
Evaluation of the safety of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.
Secondary outcomes
Intervention success
Rate of the ability to position the stent in the indicated location.
Thromboembolic complications
Rate of cerebral thromboembolic complications during the intervention and during patient follow-up.
Hemorrhagic complications
Rate of cerebral and systemic hemorrhagic complications during the intervention and during patient follow-up.
Mortality
Mortality rate during patient follow-up.
Sponsors and contacts
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