Evaluating flow-diverting stents for treating cerebral aneurysms
Official title: 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
Run by Hospital Universitario Central de Asturias · NCT06201598 · Data updated 2026-11-12
This study is testing two types of stents to see if they can safely and effectively treat cerebral aneurysms in patients across several hospitals in Spain.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Hospital Universitario Central de Asturias Academic / other |
| Locations | 11 sites (A Coruña and 10 other locations) |
| Status | Recruiting |
| Started | January 12, 2024 |
| Main results expected | December 15, 2025 |
| Study ends | December 15, 2025 |
| Registry record updated | November 22, 2024 |
| Trial ID | NCT06201598 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years old with incidental, symptomatic, or ruptured cerebral aneurysms.
✕Probably not a fit
Patients under 18 years of age, those with untreated allergies to iodinated contrast, or pregnant/breastfeeding women may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the effectiveness and safety of two types of flow-diverting stents, p64MW HPC and p48MW HPC, in treating cerebral aneurysms across multiple hospitals in Spain. It is an observational study that will analyze the success rates of the interventions, as well as the occurrence of hemorrhagic and thromboembolic complications over a 12-month follow-up period. The study utilizes commercially available devices and focuses on real-world clinical practices to gather data on patient outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and effectiveness of endovascular treatments for patients with cerebral aneurysms.
How similar studies have gone: Previous studies have shown positive outcomes with flow-diverting stents, but this specific approach with the anti-thrombogenic coating is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Hospital Universitario de A Coruña
A Coruña, Spain Recruiting -
Hospital Universitari Germans Trias I Pujol
Badalona, Spain Recruiting -
Hospital Universitari Vall D Hebron
Barcelona, Spain Recruiting -
Hospital Universitario de Burgos
Burgos, Spain Recruiting -
Hospital Universitario de Donostia
Donostia / San Sebastian, Spain Recruiting -
Hospital Universitario La Paz
Madrid, Spain Recruiting
Show 5 more locations
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Hospital Regional Universitario de Malaga
Málaga, Spain Recruiting -
Hospital Universitario Central de Asturias
Oviedo, Spain Recruiting -
Hospital Parc Tauli
Sabadell, Spain Recruiting -
Hospital Clínico Universitario de Valladolid
Valladolid, Spain Recruiting -
Hospital Universitario Miguel Servet
Zaragoza, Spain Recruiting
Study contacts
- Study coordinator: PEDRO VEGA VALDES, MD, PhD
- Email: peveval@yahoo.es
- Phone: 0034985108000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.