Analysis of Selective Cerebrovascular Distribution With FDCT in the Angiosuite

NCT03916133 | Completed

• 1 other identifier: 18/17/222
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the clinical feasibility of the angiographic Flat Detector CT perfusion imaging (6s PBV) technique. The investigators will examine the specific vessel distribution of patients with steno-occlusive disease, treated with a surgical extracranial-intracranial bypass and assess the cerebral perfusion during test occlusion upon a neurovascular treatment and in intracranial tumor patients referred for potential pre-operative embolization. This study encompasses three scientific objectives:

1. 1.What is the selective contribution of an individual bypass artery to the brain perfusion?
2. 2.Is a selective intra-arterial angiographic perfusion examination useful in the decision-making of performing pre-operative embolization of intracranial tumors?
3. 3.What is the usefulness of performing additive 6s PBV images compared to classical 2D angiography and/or clinical neurological evaluation in case of test occlusion in the evaluation of possible mother vessel occlusion in treatment of complex neurovascular diseases?

Conditions

Ischemic Stroke; Intracranial Aneurysm; Intracranial Arterial Diseases; Cerebral Hypoxia; Intracranial Vascular Disorder

Outcome Measures

Primary Outcomes (1)

• Performance of flat-detector CT imaging in angiosuite

  The quality of the imaging scans obtained with FDCT will be assessed compared to conventional imaging techniques (CT, angiography and MRI)

  1 day

Study Arms (1)

Intervention group

OTHER

Included patients will undergo angiographic FDCT perfusion imaging.The study will be embedded in the standard procedure of pre-operative diagnostics and angiographic control after EC-IC bypass treatment of steno-occlusive disease and during pre-embolization mapping and embolization procedure. An informed consent will be acquired during consultations in the preparatory process of the different examinations and treatments

Diagnostic Test: Intervention group

Interventions

Intervention group DIAGNOSTIC_TEST

6s PBV mapping will be conducted

Also known as: Flat-detector CT perfusion imaging

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for diagnostics and surgical (extracranial-intracranial bypass) treatment of steno-occlusive neurovascular disorders.
• Patients referred for hypervascular intracranial tumor resection
• Patients referred for angiographic test occlusion as part of treatment of complex neurovascular disorders.

You may not qualify if:

• Pregnant women or women trying to get pregnant
• People younger than 18 years old
• Patients with thyroid disorders and diabetes, especially those using medication with metformin.

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Antwerp, België, 2018, Belgium

Location

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Aneurysm; Intracranial Arterial Diseases; Hypoxia, Brain; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Stroke; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Aneurysm; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 16, 2019
• Study Start: June 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)