C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Diagnostic test: C-Arm Cone Beam Computed Tomography

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin, Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Diagnostic test: C-Arm Cone Beam Computed Tomography; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 study visit up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimization of One-Stop-Shop Imaging	Data collected will be used to optimize C-arm CBCT imaging parameters, data acquisition methods and contrast dose.	Up to 24 months
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.	Up to 24 months
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.	Up to 24 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Principal Investigator: Beverly Aagaard-Kienitz, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): March 26, 2020
• Study Completion (Actual): March 26, 2020

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 2015-0482; A539300 (Other Identifier: UW Madison); SMPH\RADIOLOGY\RADIOLOGY (Other Identifier: UW Madison); 1U01EB021183-01 (U.S. NIH Grant/Contract); Protocol Version 3/27/2020 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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