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NCT Number: 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

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.

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Key information

Conditions

Cerebral Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Thromboembolic Disease Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario de A Coruña, A Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group 1 - Intervention 1

Device

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

Primary outcomes

  1. Effectiveness objective

    Time frame: 1 year

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

  2. Safety Objective

    Time frame: 1 year

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

Secondary outcomes

  1. Intervention success

    Time frame: During the procedure

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

  2. Thromboembolic complications

    Time frame: 1 year

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

  3. Hemorrhagic complications

    Time frame: 1 year

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

  4. Mortality

    Time frame: 1 year

    Mortality rate during patient follow-up.

  5. Clinical evolution of the patient using the National Institutes of Health Stroke Scale (NIHSS) and the Modified Rankin Scale (MRS).

    Time frame: 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).

  6. Intimal hyperplasia

    Time frame: 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.

  7. Thromboembolic complications with a single antiplatelet drug

    Time frame: 1 year

    Rate of thromboembolic complications during the intervention and patient follow-up in cases where a single antiplatelet drug is administered.

  8. Intimal hyperplasia with a single antiplatelet drug

    Time frame: 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.

  9. Visible ischemic complications

    Time frame: 6 months

    Rate of visible ischemic complications in MRI during patient follow-up (4-6 months).

  10. Aneurysm occlusion

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

PEDRO VEGA VALDES, MD, PhD

CONTACT

[email protected]

0034985108000 ext. 39116

Sponsors and collaborators

Lead sponsor

Hospital Universitario Central de Asturias

Other

Registry information

Acronym: pSPAIN_HPC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 11, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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