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

Launched by HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS · Dec 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for people with cerebral aneurysms, which are weak spots in the blood vessels in the brain that can lead to serious complications. The researchers are looking at two specific devices, called P64 and P48 flow-diverting stents, that have a special coating designed to reduce the risk of blood clots when they are placed in the blood vessels. The goal is to see how effective and safe these devices are for patients with different types of cerebral aneurysms, including those that are discovered by chance or are causing symptoms.

To participate in this study, you need to be at least 18 years old and have a cerebral aneurysm that is either incidental (found incidentally), symptomatic (causing problems), or has ruptured (burst). You will need to provide signed consent to join the trial. If you are under 18, have a known allergy to certain contrast dyes, or are pregnant or breastfeeding, you won’t be eligible. Participants will receive the new treatment and will be monitored for its effectiveness and any potential side effects. This research is important because it may lead to safer and more effective treatments for cerebral aneurysms, helping improve patient outcomes.

Gender

ALL

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.