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C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions

Not Applicable
Completed
Conditions
Acute Ischemic Stroke
Registration Number
NCT03232151
Lead Sponsor
University of Wisconsin, Madison
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  1. Patients with acute ischemic stroke presenting within 8 hours of onset
  2. Patients that present with a large artery occlusion
  3. Adults 18 years of age or older.
  4. Women of childbearing potential must not be pregnant.
  5. National Institutes of Health Stroke Scale (NIHSS) of >5
  6. No severe co-morbidities
Exclusion Criteria
  1. Women that are pregnant
  2. History of severe renal disease (e.g. stage 4-5)
  3. History of renal transplant

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Percent of C-arm Cone Beam CT scans that detect Hyperemia or Oligemia compared to Standard of Care conventional CT1 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 Outcome Measures
NameTimeMethod
Optimization of One-Stop-Shop ImagingUp to 24 months

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

Analysis of Perfusion Parameters from One-Stop-Shop Perfusion MapsUp to 24 months

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

Analysis of ROIs from One-Stop-Shop Perfusion MapsUp 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.

Trial Locations

Locations (1)

University of Wisconsin, Madison

🇺🇸

Madison, Wisconsin, United States

University of Wisconsin, Madison
🇺🇸Madison, Wisconsin, United States
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