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

• Conditions: Cerebral Aneurysm; Thromboembolic Disease
• Interventions: Device: Group 1 - Intervention 1

• Registration Number: NCT06201598
• Lead Sponsor: Hospital Universitario Central de Asturias

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-30
• Study First Posted: 2024-01-11
• Study Start: 2024-01-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with p64MW HPC and p48MW HPC	Group 1 - Intervention 1	Patients with intracranial aneurysms or dissections undergoing endovascular treatment with p64MW HPC and p48MW HPC flow-diverting devices.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Hemorrhagic complications	1 year	Rate of cerebral and systemic hemorrhagic complications during the intervention and during patient follow-up.
Intimal hyperplasia	1 year	Rate of intimal hyperplasia within the stent leading to a luminal stenosis of over 50%, assessed through digital angiography at 4-6 months and 12 months post-treatment.
Intervention success	During the procedure	Rate of the ability to position the stent in the indicated location.
Clinical evolution of the patient using the National Institutes of Health Stroke Scale (NIHSS) and the Modified Rankin Scale (MRS).	1 year	NIHSS at 24 hours and at discharge (range 0-42, with higher scores indicating greater stroke severity).; MRS at 24 hours, at discharge, at 4-6 months and 12 months post-treatment (range 0-6, from no symptoms to dead, for the evaluation of neurological functional disability).
Thromboembolic complications with a single antiplatelet drug	1 year	Rate of thromboembolic complications during the intervention and patient follow-up in cases where a single antiplatelet drug is administered.
Thromboembolic complications	1 year	Rate of cerebral thromboembolic complications during the intervention and during patient follow-up.
Mortality	1 year	Mortality rate during patient follow-up.
Visible ischemic complications	6 months	Rate of visible ischemic complications in MRI during patient follow-up (4-6 months).
Aneurysm occlusion	1 year	Aneurysm occlusion rate assessed through digital angiography at 6 and 12 months post-intervention, according to the O'Kelly-Marotta (OKM) occlusion scale.
Intimal hyperplasia with a single antiplatelet drug	1 year	Rate of intimal hyperplasia within the stent leading to a luminal stenosis of over 50% in cases where a single antiplatelet drug is administered, assessed through digital angiography at 4-6 months and 12 months post-treatment.

Trial Locations

Locations (11)

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain

Hospital Universitario de A Coruña; 🇪🇸 A Coruña, Spain

Hospital Universitari Germans Trias I Pujol; 🇪🇸 Badalona, Spain

Hospital Universitari Vall D Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario de Donostia; 🇪🇸 Donostia, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Regional Universitario de Malaga; 🇪🇸 Málaga, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain

Hospital Parc Tauli; 🇪🇸 Sabadell, Spain

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain