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Analysis of Selective Cerebrovascular Distribution With FDCT in the Angiosuite

A

Antwerp University Hospital (UZA)

Status

Completed

Conditions

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

Treatments

Diagnostic Test: Intervention group

Study type

Interventional

Funder types

Other

Identifiers

NCT03916133
18/17/222

Details and patient eligibility

About

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?

Enrollment

127 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

127 participants in 1 patient group

Intervention group
Other group
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
Treatment:
Diagnostic Test: Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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