Clinical trial NCT06201598: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Aneurysm
Thromboembolic Disease
Keywords: Cerebral aneurysm
Flow-diverting stents
Thrombogenicity
p64 MW HPC
p48 MW HPC
Lead sponsor: Hospital Universitario Central de Asturias
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness objective
timeFrame: 1 year
measure: Safety Objective
timeFrame: 1 year
Secondary outcomes:
measure: Intervention success
timeFrame: During the procedure
measure: Thromboembolic complications
timeFrame: 1 year
measure: Hemorrhagic complications
timeFrame: 1 year
measure: Mortality
timeFrame: 1 year
measure: Clinical evolution of the patient using the National Institutes of Health Stroke Scale (NIHSS) and the Modified Rankin Scale (MRS).
timeFrame: 1 year
measure: Intimal hyperplasia
timeFrame: 1 year
measure: Thromboembolic complications with a single antiplatelet drug
timeFrame: 1 year
measure: Intimal hyperplasia with a single antiplatelet drug
timeFrame: 1 year
measure: Visible ischemic complications
timeFrame: 6 months
measure: Aneurysm occlusion
timeFrame: 1 year
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Hospital Universitario de A Coruña
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D Hebron
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Donostia
country: Spain
facility: Hospital Universitario de Donostia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Sabadell
country: Spain
facility: Hospital Parc Tauli
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
References:
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