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Completed

NCT Number: NCT03232151

C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions

The overarching objective of our proposal is to develop a One-Stop-Shop imaging using the available C-arm Cone-Beam Computed Tomography (CBCT) data acquisition systems currently widely available worldwide in interventional angiography suites to enable acute ischemic stroke patients to be imaged, triaged, treated, and assessed using a single modality in one room.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin, Madison

Madison, Wisconsin, 53705, United States

About this study

This is an evaluation to determine the efficacy of the use of C-arm CBCT with SMART RECON novel software for the rapid assessment of time-resolved CTA and CT perfusion in the setting of ischemic cerebrovascular events. As a leading center for the treatment of cerebrovascular disease in the Midwest as well as being one of the first Comprehensive Stroke Centers in the United States we have a large potential patient group to assess.

The pilot plan is to compare conventional CT/CTA/CTP acquired during the clinical work up with C-arm CBCT/CTA/CTP acquired in the angiography suite at initiation of therapy. The C-arm CBCT acquisition provides whole brain coverage (compared to only 8 cm brain coverage with conventional CT) with less radiation and higher resolution; the CT perfusion maps obtained using C-arm CBCT and new reconstruction algorithms provides better perfusion maps.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with acute ischemic stroke presenting within 8 hours of onset
  • Patients that present with a large artery occlusion
  • Adults 18 years of age or older.
  • Women of childbearing potential must not be pregnant.
  • National Institutes of Health Stroke Scale (NIHSS) of >5
  • No severe co-morbidities

Exclusion criteria

  • Women that are pregnant
  • History of severe renal disease (e.g. stage 4-5)
  • History of renal transplant

Treatment and study plan

C-Arm Cone Beam Computed Tomography

Diagnostic Test

C-ARM CBCT angiogram and CBCT perfusion imaging using prototype software (SMART-RECON) can rapidly and accurately assess the cerebral blood flow maps in the setting of decreased blood flow to the brain (ischemic cerebrovascular events). This rapid assessment would eliminate the need for the patient to be imaged in another scanner and be subsequently transported again to another room; all anatomic and physiologic imaging would occur in the angiography suite.

Other names: C-ARM CBCT

Primary outcomes

  1. Percent of C-arm Cone Beam CT scans that detect Hyperemia or Oligemia compared to Standard of Care conventional CT

    Time frame: 1 study visit up to 1 hour

    To demonstrate device feasibility for phase 2 of this study, the investigators need to demonstrate that the presence of hyperemia or oligemia detected with standard of care conventional CT is also detected to a clinically acceptable degree with C-arm Cone Beam CT.

Secondary outcomes

  1. Optimization of One-Stop-Shop Imaging

    Time frame: Up to 24 months

    Data collected will be used to optimize C-arm CBCT imaging parameters, data acquisition methods and contrast dose.

  2. Analysis of Perfusion Parameters from One-Stop-Shop Perfusion Maps

    Time frame: Up to 24 months

    Local perfusion parameters on image slices will be measured and compared against the corresponding measurements from diagnostic CTP measurements.

  3. Analysis of ROIs from One-Stop-Shop Perfusion Maps

    Time frame: Up to 24 months

    Standard deviations for a variety of regions of interest (ROIs) on image slices will be measured and compared against the corresponding measurements from diagnostic CTP measurements.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Official study title

C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions Evaluating Predictability and Accuracy for the Treatment of Acute Cerebral Ischemia in the Angiography Suite

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2017
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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