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.
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 the routine clinical practice of several Spanish hospitals. It is therefore an observational study, carried out with devices already commercialized. The success rate of the intervention, the rate of hemorrhagic and thromboembolic complications, as well as variables related to the clinical and radiological follow-up of patients over a 12-month period, will be analyzed.
Study Type
OBSERVATIONAL
Enrollment
100
Endovascular treatment of cerebral aneurysms through the implantation of p64MW HPC and p48MW HPC devices.
Hospital Universitario de A Coruña
A Coruña, Spain
RECRUITINGHospital Universitari Germans Trias I Pujol
Badalona, Spain
RECRUITINGHospital Universitari Vall D Hebron
Barcelona, Spain
RECRUITINGHospital Universitario de Burgos
Burgos, Spain
RECRUITINGHospital Universitario de Donostia
Donostia / San Sebastian, Spain
RECRUITINGHospital Universitario La Paz
Madrid, Spain
RECRUITINGHospital Regional Universitario de Malaga
Málaga, Spain
RECRUITINGHospital Universitario Central de Asturias
Oviedo, Spain
RECRUITINGHospital Parc Tauli
Sabadell, Spain
RECRUITINGHospital Clínico Universitario de Valladolid
Valladolid, Spain
RECRUITING...and 1 more locations
Effectiveness objective
Evaluation of the effectiveness of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.
Time frame: 1 year
Safety Objective
Evaluation of the safety of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.
Time frame: 1 year
Intervention success
Rate of the ability to position the stent in the indicated location.
Time frame: During the procedure
Thromboembolic complications
Rate of cerebral thromboembolic complications during the intervention and during patient follow-up.
Time frame: 1 year
Hemorrhagic complications
Rate of cerebral and systemic hemorrhagic complications during the intervention and during patient follow-up.
Time frame: 1 year
Mortality
Mortality rate during patient follow-up.
Time frame: 1 year
Clinical evolution of the patient using the National Institutes of Health Stroke Scale (NIHSS) and the Modified Rankin Scale (MRS).
NIHSS at 24 hours and at discharge (range 0-42, with higher scores indicating greater stroke severity). MRS at 24 hours, at discharge, at 4-6 months and 12 months post-treatment (range 0-6, from no symptoms to dead, for the evaluation of neurological functional disability).
Time frame: 1 year
Intimal hyperplasia
Rate of intimal hyperplasia within the stent leading to a luminal stenosis of over 50%, assessed through digital angiography at 4-6 months and 12 months post-treatment.
Time frame: 1 year
Thromboembolic complications with a single antiplatelet drug
Rate of thromboembolic complications during the intervention and patient follow-up in cases where a single antiplatelet drug is administered.
Time frame: 1 year
Intimal hyperplasia with a single antiplatelet drug
Rate of intimal hyperplasia within the stent leading to a luminal stenosis of over 50% in cases where a single antiplatelet drug is administered, assessed through digital angiography at 4-6 months and 12 months post-treatment.
Time frame: 1 year
Visible ischemic complications
Rate of visible ischemic complications in MRI during patient follow-up (4-6 months).
Time frame: 6 months
Aneurysm occlusion
Aneurysm occlusion rate assessed through digital angiography at 6 and 12 months post-intervention, according to the O'Kelly-Marotta (OKM) occlusion scale.
Time frame: 1 year
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