An observational study in Cerebral Aneurysm and Thromboembolic Disease, sponsored by Hospital Universitario Central de Asturias. Recruiting at 11 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Hospital Universitario Central de Asturias · Observational
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.
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 191 observational studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Hospital Universitario Central de Asturias is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with intracranial aneurysms or dissections undergoing endovascular treatment with p64MW HPC and p48MW HPC flow-diverting devices.
Device: Group 1 - Intervention 1
Endovascular treatment of cerebral aneurysms through the implantation of p64MW HPC and p48MW HPC devices.
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
Plan to share: No
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Hospital Universitario Central de Asturias