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C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
C-Arm Cone Beam Computed Tomography
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Acute Ischemic Stroke focused on measuring Stroke

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin, Madison

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

C-ARM CBCT

Arm Description

A C-arm CBCT evaluation with SMART RECON novel software for the rapid assessment of time-resolved CT angiogram and CT perfusion.

Outcomes

Primary Outcome Measures

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

Optimization of One-Stop-Shop Imaging
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 Maps
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 Maps
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.

Full Information

First Posted
July 18, 2017
Last Updated
May 24, 2022
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
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1. Study Identification

Unique Protocol Identification Number
NCT03232151
Brief Title
C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
March 26, 2020 (Actual)
Study Completion Date
March 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Stroke

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single center, open label, single-arm, pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
C-ARM CBCT
Arm Type
Experimental
Arm Description
A C-arm CBCT evaluation with SMART RECON novel software for the rapid assessment of time-resolved CT angiogram and CT perfusion.
Intervention Type
Diagnostic Test
Intervention Name(s)
C-Arm Cone Beam Computed Tomography
Other Intervention Name(s)
C-ARM CBCT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of C-arm Cone Beam CT scans that detect Hyperemia or Oligemia compared to Standard of Care conventional CT
Description
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.
Time Frame
1 study visit up to 1 hour
Secondary Outcome Measure Information:
Title
Optimization of One-Stop-Shop Imaging
Description
Data collected will be used to optimize C-arm CBCT imaging parameters, data acquisition methods and contrast dose.
Time Frame
Up to 24 months
Title
Analysis of Perfusion Parameters from One-Stop-Shop Perfusion Maps
Description
Local perfusion parameters on image slices will be measured and compared against the corresponding measurements from diagnostic CTP measurements.
Time Frame
Up to 24 months
Title
Analysis of ROIs from One-Stop-Shop Perfusion Maps
Description
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.
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly Aagaard-Kienitz, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin, Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions

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