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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitario Central de Asturias

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebral aneurysms.

Signed informed consent by the patient or their representative.

Disqualifiers

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 population

The study will include all patients with intracranial aneurysms or dissections suitable for endovascular treatment with a flow-diverting device, who attend the participating hospitals.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Group 1 - Intervention 1

    Device

    Endovascular treatment of cerebral aneurysms through the implantation of p64MW HPC and p48MW HPC devices.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patients treated with p64MW HPC and p48MW HPC1 intervention

Trial outcomes

Primary outcomes

1

Effectiveness objective

Evaluation of the effectiveness of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.

Time frame
1 year
2

Safety Objective

Evaluation of the safety of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.

Time frame
1 year

Secondary outcomes

1

Intervention success

Rate of the ability to position the stent in the indicated location.

Time frame
During the procedure
2

Thromboembolic complications

Rate of cerebral thromboembolic complications during the intervention and during patient follow-up.

Time frame
1 year
3

Hemorrhagic complications

Rate of cerebral and systemic hemorrhagic complications during the intervention and during patient follow-up.

Time frame
1 year
4

Mortality

Mortality rate during patient follow-up.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.