C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions

Acute Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232151
• Other study ID #: 2015-0482
• Secondary ID: 1U01EB021183-01A
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: March 26, 2020

Study information

• Verified date: May 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 26, 2020
• Est. primary completion date: March 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin, Madison	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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