Cerebral Aneurysm, Thromboembolic Disease
Conditions
Keywords
Cerebral aneurysm, Flow-diverting stents, Thrombogenicity, p64 MW HPC, p48 MW HPC
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 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.
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 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.
Interventions
DEVICEGroup 1 - Intervention 1
Endovascular treatment of cerebral aneurysms through the implantation of p64MW HPC and p48MW HPC devices.
Sponsors
Hospital Universitario Central de Asturias
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness objective | 1 year | Evaluation of the effectiveness of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals. |
| Safety Objective | 1 year | Evaluation of the safety of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemorrhagic complications | 1 year | Rate of cerebral and systemic hemorrhagic complications during the intervention and during patient follow-up. |
| Mortality | 1 year | Mortality rate during patient follow-up. |
| Clinical evolution of the patient using the National Institutes of Health Stroke Scale (NIHSS) and the Modified Rankin Scale (MRS). | 1 year | 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). |
| Intimal hyperplasia | 1 year | 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. |
| Intervention success | During the procedure | Rate of the ability to position the stent in the indicated location. |
| Intimal hyperplasia with a single antiplatelet drug | 1 year | 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. |
| Visible ischemic complications | 6 months | Rate of visible ischemic complications in MRI during patient follow-up (4-6 months). |
| Aneurysm occlusion | 1 year | Aneurysm occlusion rate assessed through digital angiography at 6 and 12 months post-intervention, according to the O'Kelly-Marotta (OKM) occlusion scale. |
| Thromboembolic complications with a single antiplatelet drug | 1 year | Rate of thromboembolic complications during the intervention and patient follow-up in cases where a single antiplatelet drug is administered. |
| Thromboembolic complications | 1 year | Rate of cerebral thromboembolic complications during the intervention and during patient follow-up. |
Countries
Spain
Contacts
Primary ContactPEDRO VEGA VALDES, MD, PhD
Outcome results
None listed