Analysis of Selective Cerebrovascular Distribution With FDCT in the Angiosuite

Ischemic Stroke Clinical Trial

Official title:

Evaluation of the Clinical Feasibility of Angiographic Flat-detector CT (FDCT) Perfusion Imaging (6sPBV) Technique.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916133
• Other study ID #: 18/17/222
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: May 2022
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. What is the selective contribution of an individual bypass artery to the brain perfusion? 2. Is a selective intra-arterial angiographic perfusion examination useful in the decision-making of performing pre-operative embolization of intracranial tumors? 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: January 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Hypoxia
• Cerebrovascular Disorders
• Hypoxia
• Hypoxia, Brain
• Intracranial Aneurysm
• Intracranial Arterial Diseases
• Intracranial Vascular Disorder
• Ischemic Stroke
• Vascular Diseases

Intervention

Diagnostic Test:
• Intervention group
6s PBV mapping will be conducted

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Antwerp	België

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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