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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
Sponsor:
Information provided by (Responsible Party):
Thijs van der Zijden, University Hospital, Antwerp

Study Description
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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?

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

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Arms and Interventions
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Arm Intervention/treatment
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
 Diagnostic Test: Intervention group
6s PBV mapping will be conducted
Other Name: Flat-detector CT perfusion imaging


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Belgium
Antwerp University Hospital
Antwerp, België, Belgium, 2018
Sponsors and Collaborators
University Hospital, Antwerp
More Information
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Responsible Party: Thijs van der Zijden, Principal Investigator, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03916133    
Other Study ID Numbers: 18/17/222
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ischemic Stroke
Intracranial Aneurysm
Hypoxia, Brain
Intracranial Arterial Diseases
Cerebrovascular Disorders
Aneurysm
Vascular Diseases
 Hypoxia
Stroke
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cardiovascular Diseases
Signs and Symptoms, Respiratory