Analysis of Selective Cerebrovascular Distribution With FDCT in the Angiosuite
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|ClinicalTrials.gov Identifier: NCT03916133|
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : May 17, 2022
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:
- What is the selective contribution of an individual bypass artery to the brain perfusion?
- Is a selective intra-arterial angiographic perfusion examination useful in the decision-making of performing pre-operative embolization of intracranial tumors?
- 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?
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke Intracranial Aneurysm Intracranial Arterial Diseases Cerebral Hypoxia Intracranial Vascular Disorder||Diagnostic Test: Intervention group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Clinical Feasibility of Angiographic Flat-detector CT (FDCT) Perfusion Imaging (6sPBV) Technique.|
|Actual Study Start Date :||June 1, 2018|
|Actual Primary Completion Date :||December 1, 2020|
|Actual Study Completion Date :||January 1, 2021|
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
6s PBV mapping will be conducted
Other Name: Flat-detector CT perfusion imaging
- Performance of flat-detector CT imaging in angiosuite [ Time Frame: 1 day ]The quality of the imaging scans obtained with FDCT will be assessed compared to conventional imaging techniques (CT, angiography and MRI)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916133
|Antwerp University Hospital|
|Antwerp, België, Belgium, 2018|