Evaluating flow-diverting stents for treating cerebral aneurysms
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
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario Central de Asturias Academic / other |
| Locations | 11 sites (A Coruña and 10 other locations) |
| Trial ID | NCT06201598 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with incidental, symptomatic, or ruptured cerebral aneurysms.
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.
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 performed: Previous studies have shown positive outcomes with flow-diverting stents, but this specific approach with the anti-thrombogenic coating is relatively novel.
Eligibility criteria
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 this trial is running
A Coruña and 10 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.