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

Condition(s) studied

Investigational drug(s) / intervention(s)

Group 1 - Intervention 1: Endovascular treatment of cerebral aneurysms through the implantation of p64MW HPC and p48MW HPC devices.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Effectiveness objective — 1 year
  Evaluation of the effectiveness of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.
• Safety Objective — 1 year
  Evaluation of the safety of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.

Trial sites (11)