Patient-specific Planning of Minimally Invasive Brain Interventions Based on Vascular-hemodynamic Mapping

NCT06588543 | Recruiting

• 1 other identifier: ONZ-2024-0129
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Endovascular procedures for treating brain aneurysms and arteriovenous malformations (AVMs) are becoming increasingly popular due to their less invasive nature and lower risk of complications. However, they still face challenges such as difficult catheter navigation and incomplete embolization. This study aims to improve the efficiency and safety of endovascular procedures by developing new preoperative planning methodologies. These methodologies involve mapping the cerebral vasculature and creating computational fluid dynamics (CFD) and artificial intelligence (AI) models to simulate blood flow. By using these models, interventional radiologists can better plan catheter navigation and predict embolization outcomes. This could lead to faster, more accurate procedures with reduced radiation exposure for patients.

Conditions

Intracranial Aneurysm; Arteriovenous Malformations, Cerebral

Outcome Measures

Primary Outcomes (4)

• Accuracy of CFD models

  Correlation coefficient between CFD-predicted and measured blood flow velocity and pressure distribution

  4 year

• Identification of important procedure parameters

  Identification of key procedure parameters (e.g., properties of embolization agent, procedural actions) using the computational framework.

  6 year

• Efficiency of AI-enhanced CFD modelling

  Time, sensitivity, specificity, and accuracy of AI models in verifying the acceleration power while maintaining high-quality results.

  6 year

• Cerebral vasculature mapping

  Development of accurate and efficient image processing methods to support clinical embolization procedures. Evaluation using independent datasets and metrics (e.g., accuracy, precision, recall, F1-score).

  6 year

Study Arms (2)

Intracranial aneurysms

Patients with at least one intracranial aneurysm that has been coiled

Device: Endovascular treatment

Arteriovenous malformations

Patients with a cerebral arteriovenous malformation that has been treated by endovascular embolisation

Device: Endovascular treatment

Interventions

Endovascular treatment DEVICE

Endovascular treatment

Arteriovenous malformations; Intracranial aneurysms

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subjects who had or will have endovascular treatment of an intracranial aneurysm or cerebral arteriovenous malformation

You may qualify if:

• Subjects who are diagnosed with aneurysm or arteriovenous malformation
• Subjects who are treated (or will be treated) with endovascular embolization and/or arteriovenous coiling
• During and before/after the subject's intervention, medical images (MRI, 3D rotational angiography, DSA) were collected of the cerebral arterial vascular tree (which can be used to develop patient-specific models), including catheter location and use of contrast fluid to visualize the cerebral to make the arterial tree more visible.

You may not qualify if:

• Procedures during which no imaging was performed

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm; Intracranial Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Peter Vanlangenhove, Prof. Dr.

CONTACT

+32 9 3323112; peter.vanlangenhove@uzgent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: September 19, 2024
• Study Start: August 13, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (1)