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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
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 10, 2019
Last Updated
May 16, 2022
Sponsor
University Hospital, Antwerp
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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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