Analysis of Selective Cerebrovascular Distribution With FDCT in the Angiosuite
Primary Purpose
Ischemic Stroke, Intracranial Aneurysm, Intracranial Arterial Diseases
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Intervention group
Sponsored by
About this trial
This is an interventional diagnostic trial for Ischemic Stroke
Eligibility 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.
Sites / Locations
- Antwerp University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention group
Arm Description
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
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03916133
First Posted
April 10, 2019
Last Updated
May 16, 2022
Sponsor
University Hospital, Antwerp
1. Study Identification
Unique Protocol Identification Number
NCT03916133
Brief Title
Analysis of Selective Cerebrovascular Distribution With FDCT in the Angiosuite
Official Title
Evaluation of the Clinical Feasibility of Angiographic Flat-detector CT (FDCT) Perfusion Imaging (6sPBV) Technique.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Intracranial Aneurysm, Intracranial Arterial Diseases, Cerebral Hypoxia, Intracranial Vascular Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Other
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Intervention group
Other Intervention Name(s)
Flat-detector CT perfusion imaging
Intervention Description
6s PBV mapping will be conducted
Primary Outcome Measure Information:
Title
Performance of flat-detector CT imaging in angiosuite
Description
The quality of the imaging scans obtained with FDCT will be assessed compared to conventional imaging techniques (CT, angiography and MRI)
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Antwerp University Hospital
City
Antwerp
State/Province
België
ZIP/Postal Code
2018
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analysis of Selective Cerebrovascular Distribution With FDCT in the Angiosuite
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