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CompletedNCT03916133Updated May 17, 2022

Analysis of Selective Cerebrovascular Distribution With FDCT in the Angiosuite

An interventional study of Intervention group in Ischemic Stroke, Intracranial Aneurysm and Intracranial Arterial Diseases, sponsored by University Hospital, Antwerp. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-17.

Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jun 2018, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
127
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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?
02

Conditions studied

  • Ischemic Stroke
  • Intracranial Aneurysm
  • Intracranial Arterial Diseases
  • Cerebral Hypoxia
  • Intracranial Vascular Disorder
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's enrollment of 127 is close to the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
127 participants (actual)

Study arms

  • Other
    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

Interventions

  • Diagnostic testIntervention group

    6s PBV mapping will be conducted

    Also known as: Flat-detector CT perfusion imaging

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 1 day

07

Study locations

1 site
  • Antwerp University Hospital
    Antwerp, België 2018, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in Dec 2020, 30 months.

Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's 30 months is close to that.

Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2019
First posted
Apr 16, 2019
StartActual
Jun 1, 2018
Primary completionActual
Dec 1, 2020
CompletionActual
Jan 1, 2021
Last update
May 17, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03916133
Responsible party
Thijs van der Zijden (Principal Investigator, University Hospital, Antwerp) — Principal investigator
First posted
Apr 16, 2019
Start date
Jun 1, 2018
Primary completion
Dec 1, 2020
Completion
Jan 1, 2021
Last update
May 17, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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