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

Recruiting now

Conditions studied: Cerebral Aneurysm, Thromboembolic Disease

In brief

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.

Key facts

Study ID

NCT06201598

Run by

Hospital Universitario Central de Asturias

People needed

100

Starts

2024-01-12

Expected to finish

2025-12-15

Last updated by the study team

2024-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebral aneurysms.
• Signed informed consent by the patient or their representative.

You may not qualify if…

• 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 is running

• Hospital Universitario de A Coruña — A Coruña, Spain (enrolling)
• Hospital Universitari Germans Trias I Pujol — Badalona, Spain (enrolling)
• Hospital Universitari Vall D Hebron — Barcelona, Spain (enrolling)
• Hospital Universitario de Burgos — Burgos, Spain (enrolling)
• Hospital Universitario de Donostia — Donostia / San Sebastian, Spain (enrolling)
• Hospital Universitario La Paz — Madrid, Spain (enrolling)
• Hospital Regional Universitario de Malaga — Málaga, Spain (enrolling)
• Hospital Universitario Central de Asturias — Oviedo, Spain (enrolling)
• Hospital Parc Tauli — Sabadell, Spain (enrolling)
• Hospital Clínico Universitario de Valladolid — Valladolid, Spain (enrolling)
• Hospital Universitario Miguel Servet — Zaragoza, Spain (enrolling)

Full record on ClinicalTrials.gov

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