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 (pSPAIN_HPC)

Hospital Universitario Central de Asturias

Status: Enrolling

Conditions: Thromboembolic Disease; Cerebral Aneurysm

Treatments: Device: Group 1 - Intervention 1

Study type: Observational

Funder types: Other

Identifiers

NCT06201598

2023.014

Details and patient eligibility

About

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.

Full description

The goal of this study is to evaluate the effectiveness and safety of endovascular treatment for cerebral aneurysms using the flow-diverting stents p64MW (flow modulation device) HPC and p48MW HPC in the routine clinical practice of several Spanish hospitals. It is therefore an observational study, carried out with devices already commercialized. The success rate of the intervention, the rate of hemorrhagic and thromboembolic complications, as well as variables related to the clinical and radiological follow-up of patients over a 12-month period, will be analyzed.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Patients treated with p64MW HPC and p48MW HPC

Description:

Patients with intracranial aneurysms or dissections undergoing endovascular treatment with p64MW HPC and p48MW HPC flow-diverting devices.

Treatment:

Device: Group 1 - Intervention 1