Clinical trial Recruiting at 11 sites Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorHospital Universitario Central de Asturias
Academic / other
Locations11 sites (A Coruña and 10 other locations)
StatusRecruiting
StartedJanuary 12, 2024
Main results expectedDecember 15, 2025
Study endsDecember 15, 2025
Registry record updatedNovember 22, 2024
Trial IDNCT06201598 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.