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)

May 10, 2024 updated by: Pedro Vega Valdes, Hospital Universitario Central de Asturias
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: PEDRO VEGA VALDES, MD, PhD
  • Phone Number: 39116 0034985108000
  • Email: peveval@yahoo.es

Study Locations

  • Spain
      • A Coruña, Spain, 15006
        • Recruiting
        • Hospital Universitario de A Coruña
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall D Hebron
      • Donostia, Spain, 20014
        • Recruiting
        • Hospital Universitario de Donostia
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
      • Oviedo, Spain, 33006
        • Recruiting
        • Hospital Universitario Central de Asturias
      • Sabadell, Spain, 08208
        • Recruiting
        • Hospital Parc Tauli
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Miguel Servet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated with p64MW HPC and p48MW HPC
Patients with intracranial aneurysms or dissections undergoing endovascular treatment with p64MW HPC and p48MW HPC flow-diverting devices.
Device: Group 1 - Intervention 1
Endovascular treatment of cerebral aneurysms through the implantation of p64MW HPC and p48MW HPC devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention success
Time Frame: During the procedure
Rate of the ability to position the stent in the indicated location.
During the procedure
Thromboembolic complications
Time Frame: 1 year
Rate of cerebral thromboembolic complications during the intervention and during patient follow-up.
1 year
Hemorrhagic complications
Time Frame: 1 year
Rate of cerebral and systemic hemorrhagic complications during the intervention and during patient follow-up.
1 year
Mortality
Time Frame: 1 year
Mortality rate during patient follow-up.
1 year
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).
1 year
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.
1 year
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.
1 year
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.
1 year
Visible ischemic complications
Time Frame: 6 months
Rate of visible ischemic complications in MRI during patient follow-up (4-6 months).
6 months
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Central de Asturias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

December 30, 2023

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023.014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Aneurysm

Clinical Trials on Group 1 - Intervention 1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe