Analysis of Selective Cerebrovascular Distribution With FDCT in the Angiosuite

Not Applicable

Completed

• Conditions: Cerebral Hypoxia; Ischemic Stroke; Intracranial Aneurysm; Intracranial Arterial Diseases; Intracranial Vascular Disorder
• Interventions: Diagnostic Test: Intervention group

• Registration Number: NCT03916133
• Lead Sponsor: University Hospital, Antwerp

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. 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?

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Primary Completion: 2020-12-01
• Study Completion: 2021-01-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Intervention group	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

Primary Outcome Measures

Name	Time	Method
Performance of flat-detector CT imaging in angiosuite	1 day	The quality of the imaging scans obtained with FDCT will be assessed compared to conventional imaging techniques (CT, angiography and MRI)

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Antwerp, België, Belgium