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 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-01-12 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06201598 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cerebral Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06201598 currently recruiting?
Yes, NCT06201598 is actively recruiting participants. Contact the research team at peveval@yahoo.es for enrollment information.
Where is the NCT06201598 trial being conducted?
This trial is being conducted at A Coruña, Spain, Badalona, Spain, Barcelona, Spain, Burgos, Spain and 7 additional locations.
Who is sponsoring the NCT06201598 clinical trial?
NCT06201598 is sponsored by Hospital Universitario Central de Asturias. The trial plans to enroll 100 participants.