NCT06201598 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
| NCT ID | NCT06201598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitario Central de Asturias |
| Condition | Cerebral Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-01-12 |
| Primary Completion | 2025-12-15 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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.
Eligibility Criteria
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.