Clinical Trials Logo
  1. Home
  2. Cerebral Aneurysm
  3. 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 — pSPAIN_HPC  

Cerebral Aneurysm Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06201598
Study type Observational
Source Hospital Universitario Central de Asturias
Contact PEDRO VEGA VALDES, MD, PhD
Phone 0034985108000
Email peveval@yahoo.es
Status Recruiting
Phase
Start date January 12, 2024
Completion date December 15, 2025
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04583163 - Variability in Transcranial Doppler Technique in Neuro-Critical Care Patients
Recruiting NCT03306823 - Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 1 N/A
Recruiting NCT03306836 - Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 2 N/A
Recruiting NCT02345395 - Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms N/A
Completed NCT00962546 - Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage N/A
Recruiting NCT04141020 - Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms Phase 2
Recruiting NCT01460563 - Valproic Acid, Magnesium Sulphate, Rocuronium Requirement, Postoperative Analgesia N/A
Completed NCT02507999 - Goal-directed Therapy in Endovascular Coiling of Cerebral Aneurysm Patients N/A
Recruiting NCT02162654 - Remote Ischemic Preconditioning for Intracranial Aneurysm Treatment N/A
Completed NCT01943591 - DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial N/A
Recruiting NCT03815149 - Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms
Completed NCT03152201 - New Findings About Somatosensory Evoked Potentials (SEP) During Surgery for Cerebral Aneurysms
Recruiting NCT02444832 - Multicenter Retrospective Registry of Anterior Communicating Artery Aneurysms With Endovascular Therapy N/A
Active, not recruiting NCT05774782 - Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification N/A
Withdrawn NCT01878136 - Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage Phase 1/Phase 2
Completed NCT02455440 - Esmolol Infusion in Patients Undergoing Craniotomy Phase 3
Withdrawn NCT02011321 - Clevidipine for Vasospasm After Subarachnoid Hemorrhage (SAH) Phase 2
Completed NCT00614887 - Hypothalamo-, Pituitary-, Adrenal Axis Dysfunction in Subarachnoid Hemorrhage
Terminated NCT02281721 - Surpass Flow Diverter for Intracranial Aneurysms: SURMOUNT Registry Data Collection
Completed NCT04963933 - A Medical Device to Treat Brain Aneurysms N/A